essential prescribing information coated vicryl ...® family of... · coated vicryl* rapide...

Essential Prescribing Information Coated VICRYL* (Polyglactin 910) Suture USP EXCEPT FOR DIAMETER INDICATIONS Coated VICRYL suture is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological tissues. CONTRAINDICATIONS This suture, being absorbable, should not be used where extended approximation of tissue is required. WARNINGS Users should be familiar with surgical procedures and techniques involving absorbable sutures before employing Coated VICRYL suture for wound closure, as risk of wound dehiscence may vary with the site of application and the suture material used. Physicians should consider the in vivo performance (under ACTIONS section) when selecting a suture. The use of this suture may be inappropriate in elderly, malnourished, or debilitated patients, or in patients suffering from conditions which may delay wound healing. As this is an absorbable suture material, the use of supplemental nonabsorbable sutures should be considered by the surgeon in the closure of the sites which may undergo expansion, stretching or distention, or which may require additional support. Do not resterilize. Discard opened packages and unused sutures. As with any foreign body, prolonged contact of any suture with salt solutions, such as those found in the urinary or biliary tracts, may result in calculus formation. As an absorbable suture, Coated VICRYL suture may act transiently as a foreign body. Acceptable surgical practice should be followed for the management of contaminated or infected wounds. PRECAUTIONS Skin sutures which must remain in place longer than 7 days may cause localized irritation and should be snipped off or removed as indicated. Under some circumstances, notably orthopaedic procedures, immobilization of joints by external support may be employed at the discretion of the surgeon. Consideration should be taken in the use of absorbable sutures in tissues with poor blood supply as suture extrusion and delayed absorption may occur. In handling this or any other suture material, care should be taken to avoid damage from handling. Avoid crushing or crimping damage due to application of surgical instruments such as forceps or needle holders. Coated VICRYL sutures, which are treated to enhance handling characteristics, require the accepted surgical technique of flat and square ties with additional throws as warranted by surgical circumstance and the experience of the surgeon.

Avoid prolonged exposure to elevated temperatures. To avoid damaging needle points and swage areas, grasp the needle in an area one-third (1/3) to one-half (1/2) of the distance from the swaged end to the point. Reshaping needles may cause them to lose strength and be less resistant to bending and breaking. Users should exercise caution when handling surgical needles to avoid inadvertent needle sticks. Discard used needles in “sharps” container. ADVERSE REACTIONS Adverse effects associated with the use of this device include wound dehiscence, failure to provide adequate wound support in closure of the sites where expansion, stretching, or distension occur, failure to provide adequate wound support in elderly, malnourished or debilitated patients or in patients suffering from conditions which may delay wound healing, infection, minimal acute inflammatory tissue reaction, localized irritation when skin sutures are left in place for greater than 7 days, suture extrusion and delayed absorption in tissue with poor blood supply, calculi formation in urinary and biliary tracts when prolonged contact with salt solutions such as urine and bile occurs, and transitory local irritation at the wound site. Broken needles may result in extended or additional surgeries or residual foreign bodies. Inadvertent needle sticks with contaminated surgical needles may result in the transmission of bloodborne pathogens. See Package Insert for Full Prescribing Information. *Trademark

Coated VICRYL* RAPIDE (polyglactin 910)Braided Coated Synthetic Absorbable Suture, Undyed

Non-U.S.P.DESCRIPTIONCoated VICRYL* RAPIDE ( polyglactin 910) suture is a synthetic absorbable sterile surgical suture composed of a copolymer made from 90 % glycolide and 10 % L-lactide. The empirical formula of the copolymer is (C2H2O2)m(C3H4O2)n. The characteristic of rapid loss of strength is achieved by use of a polymer material with a lower molecular weight than Coated VICRYL* (polyglactin 910) suture.Coated VICRYL* RAPIDE sutures are obtained by coating the braided suture material with copolymer composed of 90 % caprolactone and 10 % glycolide followed by a mixture composed of equal parts of copolymer of glycolide and lactide (polyglactin 370) and calcium stearate. Polyglactin 910 copolymer and its coatings have been found to be nonantigenic, nonpyrogenic and elicit only a mild tissue reaction during absorption. Coated VICRYL* RAPIDE sutures are only available undyed.Although this suture is a synthetic absorbable suture, its performance characteristics are intended to model the performance of collagen (surgical gut) suture. The knot tensile strength of Coated VICRYL* RAPIDE suture meets U.S.P. knot tensile strength requirements for collagen sutures.

MAXIMUM SUTURE OVERSIZE IN DIAMETER (mm) FROM U.S.P. U.S.P. SUTURE SIZE DESIGNATION MAXIMUM OVERSIZE (mm) 6-0 .008 5-0 .016 4-0 .017 3-0 .018 2-0 .010 0 .022INDICATIONSCoated VICRYL* RAPIDE synthetic absorbable suture is indicated only for use in superficial soft tissue approximation of the skin and mucosa, where only short term wound support (7–10 days) is required. Coated VICRYL* RAPIDE suture is not intended for use in ligation, ophthalmic, cardiovascular or neurological procedures.ACTIONSCoated VICRYL* RAPIDE suture, when used in closure of skin and mucous membranes, typically begins to fall off 7 – 10 days post-operatively and can be wiped off subsequently with sterile gauze. Natural mechanical abrasion of the sutures while in situ may also accelerate this disappearance rate. Rapid loss of tensile strength may preclude the need for stitch removal.Coated VICRYL* RAPIDE elicits a minimal to moderate acute inflammatory reaction in tissue. Progressive loss of tensile strength and eventual absorption of Coated VICRYL* RAPIDE occurs by means of hydrolysis, where the copolymer degrades to glycolic and lactic acids which are subsequently absorbed and metabolized in the body. Absorption begins as a loss of tensile strength followed by a loss of mass.Subcutaneous tissue implantation studies of Coated VICRYL* RAPIDE sutures in rats show that 5 days post-implantation approximately 50 % of the original tensile strength remains. All of the original tensile strength is lost by approximately 10 to 14 days post-implantation. Intramuscular implantation studies in rats show that the absorption of these sutures occurs thereafter and is essentially complete by 42 days.CONTRAINDICATIONSDue to the rapid loss of tensile strength, this suture should not be used where extended approximation of tissues under stress is required or where wound support beyond 7 days is required.WARNINGSUsers should be familiar with surgical procedures and techniques involving absorbable sutures before employing Coated VICRYL* RAPIDE suture for wound closure, as a risk of wound dehiscence may vary with the site of application and the suture material used. Physicians should consider the in vivo performance when selecting a suture. The use of this suture may be inappropriate in elderly, malnourished, or debilitated patients, or in patients suffering from conditions which may delay wound healing.

a companySomerville, New Jersey 08876-0151

Do not resterilize. Discard opened packages and unused sutures. As with any foreign body, prolonged contact of any suture with salt solutions, such as those found in the urinary or biliary tracts, may result in calculus formation. As an absorbable suture, Coated VICRYL* RAPIDE suture may act transiently as a foreign body.Acceptable surgical practice should be followed for the management of contaminated or infected wounds.As this is an absorbable suture material, the use of supplemental nonabsorbable sutures should be considered by the surgeon in the closure of sites which may undergo expansion, stretching or distention, or which may require additional support.PRECAUTIONSSkin sutures which remain in place longer than 7 days may cause localized irritation and should be snipped off or removed as indicated.Under some circumstances, notably orthopaedic procedures, immobilization of joints by external support may be employed at the discretion of the surgeon.Consideration should be taken in the use of absorbable sutures in tissues with poor blood supply as suture extrusion and delayed absorption may occur. In handling this or any other suture material, care should be taken to avoid damage from handling. Avoid crushing or crimping damage due to application of surgical instruments such as forceps or needle holders. Coated VICRYL* RAPIDE suture, which is treated with coating to enhance handling characteristics, requires the accepted surgical technique of flat and square ties with additional throws as warranted by surgical circumstance and the experience of the surgeon.Avoid prolonged exposure to elevated temperatures.To avoid damaging needle points and swage areas, grasp the needle in an area one-third (1/3) to one-half (1/2) of the distance from the swaged end to the point. Reshaping needles may cause them to lose strength and be less resistant to bending and breaking.Users should exercise caution when handling surgical needles to avoid inadvertent needle sticks. Discard used needles in “sharps” containers.ADVERSE REACTIONSAdverse effects associated with the use of this device include wound dehiscence, failure to provide adequate wound support in closure of the sites where expansion, stretching, or distension occur, failure to provide adequate wound support in elderly, malnourished or debilitated patients or in patients suffering from conditions which may delay wound healing, infection, minimal acute inflammatory tissue reaction, localized irritation when skin sutures are left in place for greater than 7 days, suture extrusion and delayed absorption in tissue with poor blood supply, calculi formation in urinary and biliary tracts when prolonged contact with salt solutions such as urine and bile occurs, and transitory local irritation at the wound site. Broken needles may result in extended or additional surgeries or residual foreign bodies. Inadvertent needle sticks with contaminated surgical needles may result in the transmission of bloodborne pathogens. HOW SUPPLIEDCoated VICRYL* RAPIDE sutures are available sterile, undyed and attached to stainless steel needles of varying types and sizes. Coated VICRYL* RAPIDE sutures are available in various lengths in sizes 6-0 to 1 (0.7 to 4.0 metric) in one and three dozen boxes.

389307.R03 *Trademark ©ETHICON, INC. 2004

Method of sterilizationSee instructions for useDo not reuse / resterilizeBatch numberUse by – Year and month

DESCRIPTIONCoated VICRYL* Plus Antibacterial ( Polyglactin 910)Suture is a synthetic absorbable, sterile, surgical suturecomposed of a copolymer made from 90% glycolide and10% L-lactide. Coated VICRYL Plus Antibacterial Sutureis coated with a mixture composed of equal parts of acopolymer of glycolide and lactide (Polyglactin 370) andcalcium stearate. The suture contains Irgacare MP**(triclosan), a broad-spectrum antibacterial agent, at nomore than 472ug/m. The copolymers in this product havebeen found to be nonantigenic, nonpyrogenic and elicitonly a mild tissue reaction during absorption. The sutureis available undyed (natural) or dyed (D&C Violet No.2).Coated VICRYL Plus Antibacterial Sutures meet all therequirements established by the United StatesPharmacopoeia (U.S.P.) for Synthetic Absorbable SurgicalSuture (except for diameter) in the following sizes:

MAXIMUM SUTURE OVERSIZE IN DIAMETER (mm) FROM U.S.P.U.S.P. SUTURE SIZE DESIGNATION MAXIMUM OVERSIZE (mm)

5-0 .0164-0 .0173-0 .0182-0 .0040 .022

INDICATIONSCoated VICRYL Plus Antibacterial Suture is indicated foruse in general soft tissue approximation and/or ligation,except for ophthalmic, cardiovascular and neurological tissues.ACTIONSCoated VICRYL Plus Antibacterial Suture elicits a minimalacute inflammatory reaction in tissue and ingrowth offibrous connective tissue. Progressive loss of tensilestrength and eventual absorption of Coated VICRYL PlusAntibacterial Suture occurs by means of hydrolysis,where the copolymer degrades to glycolic and lacticacids, which are subsequently absorbed and metabolizedin the body. Absorption begins as a loss of tensilestrength followed by a loss of mass. Implantation studiesin rats indicate that Coated VICRYL Plus AntibacterialSuture retains approximately 75% of the original tensilestrength at two weeks post implantation. At three weeks,approximately 50% of the original strength is retained. Atfour weeks, approximately 25% of the original strength is

retained. All of the original tensile strength is lost by fiveweeks post implantation. Absorption of Coated VICRYLPlus Antibacterial Suture is essentially complete between56 and 70 days.

APPROXIMATE % ORIGINALDAYS IMPLANTATION STRENGTH REMAINING

14 Days 75%21 Days 50%28 Days 25%

Using zone of inhibition studies, Irgacare MP (triclosan) inCoated VICRYL Plus Antibacterial Suture has been shownto inhibit colonization of the suture by Staphylococcusaureus, Staphylococcus epidermidis, Methicillin ResistantS. aureus and Methicillin Resistant S. epidermidis whichare microorganisms known to contribute to surgical siteinfections. Animal studies have demonstrated that VICRYLPlus inhibits bacterial colonization of suture after direct in vivochallenge with bacteria. The clinical significance of thisfinding is unknown. CONTRAINDICATIONSThis suture, being absorbable, should not be used whereextended approximation of tissue under stress is required.Coated VICRYL Plus Antibacterial Suture should not beused in patients with known allergic reactions to IrgacareMP (triclosan).WARNINGSUsers should be familiar with surgical procedures andtechniques involving absorbable sutures beforeemploying Coated VICRYL Plus Antibacterial Suture forwound closure, as risk of wound dehiscence may varywith the site of application and the suture material used.Physicians should consider the in vivo performance(under ACTIONS section) when selecting a suture. Theuse of this suture may be inappropriate in elderly,malnourished, or debilitated patients, or in patientssuffering from conditions which may delay woundhealing. As this is an absorbable suture material, the useof supplemental nonabsorbable sutures should beconsidered by the surgeon in the closure of the siteswhich may undergo expansion, stretching or distention,or which may require additional support.Do not resterilize. Discard opened packages and unused sutures.As with any foreign body, prolonged contact of any suturewith salt solutions, such as those found in the urinary orbiliary tracts, may result in calculus formation. As anabsorbable suture, Coated VICRYL Plus AntibacterialSuture may act transiently as a foreign body. Acceptablesurgical practice should be followed for the managementof contaminated or infected wounds.

1 2

(Polyglactin 910) SutureU.S.P., EXCEPT FOR DIAMETER

HOW SUPPLIEDCoated VICRYL Plus Antibacterial Sutures are availablesterile, as braided, dyed (violet) and undyed (natural)strands in sizes 5-0 through 2 (metric sizes 1 - 5) in avariety of lengths, with or without needles, and onLIGAPAK*dispensing reels.Needles may be attached permanently or as CONTROLRELEASE* removable needles enabling the needles to bepulled off instead of being cut off. Coated VICRYL PlusAntibacterial Sutures are available in one, two and threedozen boxes. Full details are contained in the catalog.

PRECAUTIONSSkin sutures which must remain in place longer than 7days may cause localized irritation and should be snippedoff or removed as indicated.Under some circumstances, notably orthopaedicprocedures, immobilization of joints by external supportmay be employed at the discretion of the surgeon.Consideration should be taken in the use of absorbablesutures in tissues with poor blood supply as sutureextrusion and delayed absorption may occur.In handling this or any other suture material, care shouldbe taken to avoid damage from handling. Avoid crushingor crimping damage due to application of surgicalinstruments such as forceps or needle holders. CoatedVICRYL Plus Antibacterial Sutures, which are treated toenhance handling characteristics, require the acceptedsurgical technique of flat and square ties with additionalthrows as warranted by surgical circumstance and theexperience of the surgeon.Avoid prolonged exposure to elevated temperatures.To avoid damaging needle points and swage areas, graspthe needle in an area one-third (1/3) to one-half (1/2) ofthe distance from the swaged end to the point. Reshapingneedles may cause them to lose strength and be lessresistant to bending and breaking. Users should exercisecaution when handling surgical needles to avoidinadvertent needle sticks. Discard used needles in"sharps" container.ADVERSE REACTIONSAdverse effects associated with the use of this deviceinclude wound dehiscence, failure to provide adequatewound support in closure of the sites where expansion,stretching, or distension occur, failure to provideadequate wound support in elderly, malnourished ordebil i tated patients or in patients suffering fromconditions which may delay wound healing, infection,minimal acute inflammatory tissue reaction, localizedirritation when skin sutures are left in place for greaterthan 7 days, suture extrusion and delayed absorption intissue with poor blood supply, calculi formation in urinaryand biliary tracts when prolonged contact with saltsolutions such as urine and bile occurs, and transitorylocal irritation at the wound site, as well as allergicreaction to Irgacare MP (triclosan). Broken needles mayresult in extended or additional surgeries or residualforeign bodies. Inadvertent needle sticks withcontaminated surgical needles may result in thetransmission of bloodborne pathogens.

a company

Somerville, New Jersey 08876-0151

3 4

See instructions for use

Do not reuse/resterilize

Use by — year & month

LOTBatch number

Method of Sterilization —Ethylene Oxide

*Trademark of ETHICON, INC.**Trademark of Ciba Specialty Chemicals Corporation.©ETHICON,INC. 2002389595.R04

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Essential Prescribing Information

Surgical Stainless Steel Suture Nonabsorbable Surgical Sutures, USP INDICATIONS Surgical stainless steel suture is indicated for use in abdominal wound closure, hernia repair, sternal closure and orthopaedic procedures including cerclage and tendon repair. CONTRAINDICATIONS The use of this suture is contraindicated in patients with known sensitivities or allergies to 316L stainless steel, or constituent metals such as chromium and nickel. WARNINGS Users should be familiar with surgical procedures and techniques involving nonabsorbable, stainless steel sutures before employing for wound closure, as the risk of wound dehiscence may vary with the site of application and the suture material used. Acceptable surgical practice must be followed for the management of contaminated or infected wounds. PRECAUTIONS In handling this or any other suture material, care should be taken to avoid damage from handling, such as kinking or excessive twisting. To avoid damaging needle points and swage areas, grasp the needle in an area one-third (1/3) to one-half (1/2) of the distance from the swaged end to the point. Reshaping needles may cause them to lose strength and be less resistant to bending and breaking. Users should exercise caution when handling surgical needles to avoid inadvertent needle sticks. Discard used needles in "sharps" containers. ADVERSE REACTIONS Adverse effects associated with the use of this device include wound dehiscence, allergic response in patients with known sensitivities to 316L stainless steel, or constituent metals such as chromium and nickel, infection, minimal acute inflammatory tissue reaction, pain, edema and local irritation at the wound site. Broken needles may result in extended or additional surgeries or residual foreign bodies. Inadvertent needle sticks with contaminated surgical needles may result in the transmission of bloodborne pathogens. See Package Insert for Full Prescribing Information. *Trademark

Essential Prescribing Information PRONOVA* POLY (HEXAFLUOROPROPYLENE-VDF) SUTURE NONABSORBABLE SURGICAL SUTURE, USP Except for size 7-0 diameter INDICATIONS PRONOVA suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures. CONTRAINDICATIONS None known. WARNINGS Users should be familiar with surgical procedures and techniques involving nonabsorbable sutures before employing PRONOVA suture for wound closure, as risk of wound dehiscence may vary with the site of application and the suture material used. Do not resterilize. Discard opened packages and unused sutures. As with any foreign body, prolonged contact of any suture with salt solutions, such as those found in the urinary or biliary tracts, may result in calculus formation. Acceptable surgical practice must be followed for the management of infected or contaminated wounds. PRECAUTIONS In handling this suture material, care should be taken to avoid damage from handling. Avoid crushing or crimping damage due to application of surgical instruments such as forceps or needle holders. Adequate knot security requires the accepted surgical technique of flat, square ties of single suture strands. The use of additional throws is particularly appropriate when knotting monofilament sutures. To avoid damaging needle points and swage areas, grasp the needle in an area one-third (1/3) to one-half (1/2) of the distance from the swaged end to the point. Reshaping needles may cause them to lose strength and be less resistant to bending and breaking. Users should exercise caution when handling surgical needles to avoid inadvertent needle sticks. Discard used needles in "sharps" containers. ADVERSE REACTIONS Adverse effects associated with the use of this device include wound dehiscence, calculi formation in urinary and biliary tracts when prolonged contact with salt solutions such as urine and bile occurs, infection, minimal to mild inflammatory tissue reaction, and transitory local irritation at the wound site. Broken needles may result in extended or additional surgeries or residual foreign bodies. Inadvertent needle sticks with contaminated surgical needles may result in the transmission of bloodborne pathogens. See Package Insert for Full Prescribing Information. *Trademark

Essential Prescribing Information PROLENE* Polypropylene Suture Nonabsorbable Surgical Suture, USP Except for size 7-0 diameter and HEMO-SEAL* Needle Suture Attachment INDICATIONS PROLENE suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures. CONTRAINDICATIONS None known. WARNINGS Users should be familiar with surgical procedures and techniques involving nonabsorbable sutures before employing PROLENE Suture for wound closure, as risk of wound dehiscence may vary with the site of application and the suture material used. Do not resterilize. Discard opened packages and unused sutures. As with any foreign body, prolonged contact of any suture with salt solutions, such as those found in the urinary or biliary tracts, may result in calculus formation. Acceptable surgical practice must be followed for the management of infected or contaminated wounds. PRECAUTIONS In handling this suture material, care should be taken to avoid damage from handling. Avoid crushing or crimping damage due to application of surgical instruments such as forceps or needle holders. Adequate knot security requires the accepted surgical technique of flat, square ties of single suture strands. The use of additional throws is particularly appropriate when knotting polypropylene sutures. To avoid damaging needle points and swage areas, grasp the needle in an area one-third (1/3) to one-half (1/2) of the distance from the swaged end to the point. Reshaping needles may cause them to lose strength and be less resistant to bending and breaking. Users should exercise caution when handling surgical needles to avoid inadvertent needle sticks. Discard used needles in "sharps" containers. ADVERSE REACTIONS Adverse effects associated with the use of this device include wound dehiscence, calculi formation in urinary and biliary tracts when prolonged contact with salt solutions such as urine and bile occurs, infection, minimal acute inflammatory tissue reaction, and transitory local irritation at the wound site. Broken needles may result in extended or additional surgeries or residual foreign bodies. Inadvertent needle sticks with contaminated surgical needles may result in the transmission of bloodborne pathogens.

See Package Insert for Full Prescribing Information. *Trademark

Essential Prescribing Information

PERMA-HAND* Silk Suture Nonabsorbable Surgical Suture, USP

INDICATIONS PERMA-HAND Suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.

CONTRAINDICATIONS The use of this suture is contraindicated in patients with known sensitivities or allergies to silk.

Due to the gradual loss of tensile strength which may occur over prolonged periods in vivo, silk should not be used where permanent retention of tensile strength is required.

WARNINGS Users should be familiar with surgical procedures and techniques involving nonabsorbable sutures before employing PERMA-HAND Suture for wound closure, as risk of wound dehiscence may vary with the site of application and the suture material used.

As with any foreign body, prolonged contact of any suture with salt solutions, such as those found in the urinary or biliary tracts, may result in calculus formation.

Do not resterilize. Discard opened packages and unused sutures

Acceptable surgical practice should be followed for the management of infected or contaminated wounds.

PRECAUTIONS In handling this or any other suture material, care should be taken to avoid damage from handling. Avoid crushing or crimping damage due to application of surgical instruments such as forceps or needle holders. As with any suture material, adequate knot security requires the accepted surgical technique of flat and square ties with additional throws as warranted by surgical circumstance and the experience of the surgeon.

ADVERSE REACTIONS Adverse effects associated with the use of this device include wound dehiscence, gradual loss of all tensile strength over time, allergic response in patients that are known to be sensitive to silk, calculi formation in urinary and biliary tracts when prolonged contact with salt solutions such as urine and bile occurs, infection, acute inflammatory tissue reaction, and transitory local irritation at the wound site.

See Package Insert for Full Prescribing Information.

*Trademark

PDS* Plus Antibacterial (Polydioxanone) Suture Dyed and Clear Monofilament Synthetic Absorbable Sutures, U.S.P., except for diameter. Description PDS* Plus Antibacterial (polydioxanone) monofilament synthetic absorbable suture is prepared from the polyester, poly (p-dioxanone). The empirical molecular formula of the polymer is (C4H6O3)x. the suture contains Irgacare MP** (triclosan), a broad-spectrum antibacterial agent, at no more than 2360 µg/m. PDS Plus Antibacterial dyed suture is dyed with D&C Violet No. 2. Polydioxanone polymer has been found to be nonallergenic, nonpyrogenic and elicits only a slight tissue reaction during absorption. PDS Plus Antibacterial sutures are U.S.P., except for diameter.

Maximum Suture Oversize in Diameter (mm) from U.S.P.

U.S.P. Suture Size Designation Max. Oversize (mm)

6-0 0.015

5-0 0.029

4-0 0.029

3-0 0.056

2-0 0.029

0 0.071

1 0.047

Indications PDS Plus Antibacterial sutures are indicated for use in soft tissue approximation, including use in pediatric cardiovascular tissue where growth is expected to occur and ophthalmic surgery (other than contact with cornea and sclera). PDS Plus Antibacterial suture is not indicated in adult cardiovascular tissue, microsurgery, and neural tissue. These sutures are particularly useful where the combination of an absorbable suture and extended wound support (up to six weeks is desirable. Actions Two important characteristics describe the in vivo performance of absorbable sutures: first, tensile strength retention, and second, the absorption rate (loss of mass). PDS Plus Antibacterial suture has been formulated to minimize the variability of these characteristics and to provide wound support through an extended healing period. Data obtained from an implantation study in rats shows that PDS Plus Antibacterial suture is essentially absorbed between 182 and 238 days post-implantation.

The results of implantation studies indicate the percentage of original strength is retained as follows:

Days Implantation

Approximate % Original Strength

Remaining 4-0 and Smaller

Approximate %Original Strength

Remaining 3-0 and Smaller

14 DAYS 60% 80% 28 DAYS 40% 70% 42 DAYS 35% 60%

Using zone of inhibition studies, Irgacare MP (triclosan) in PDS Plus Antibacterial suture has been shown to inhibit colonization of the suture by Staphylococcus aureus, Staphylococcus epidermidis, Methicillin Resistant S. aureus, Methicillin Resistant S. epidermidis, Escherichia coli, and Klebsiella neumoniae which are microorganisms known to contribute to surgical site infections. Animal studies have demonstrated that PDS Plus Antibacterial suture inhibits bacterial colonization of suture after direct in vivo challenge with bacteria. Contraindications PDS Plus Antibacterial suture, being absorbable, is not to be used where prolonged (beyond six weeks) approximation of tissues under stress is required and is not to be used in conjunction with prosthetic devices (i.e., heart valves or synthetic grafts). PDS Plus Antibacterial suture should not be used in patients with known allergic reactions to Irgacare MP (triclosan). Warnings The safety and effectiveness of PDS Plus Antibacterial sutures have not been established in neural tissue, adult cardiovascular tissue, microsurgery, or for contact with cornea or sclera. Under certain circumstances, notably orthopedic procedures, immobilization by external support may be employed at the discretion of the surgeon. Do not resterilize. Discard open packages and unused sutures. Do not use after expiration date. Precautions The PDS Plus Antibacterial suture knots must be properly placed to be secure. As with other synthetic sutures, knot security requires the standard surgical technique of flat and square ties with additional throws if indicated by surgical circumstance and the experience of the operator. As with any suture, care should be taken to avoid damage when handling. Avoid the crushing or crimping application of surgical instruments, such as needle holders and forceps, to the strand except when grasping the free end of the suture during an instrument tie. Vaginal mucosal sutures remaining in place for extended periods may be associated with localized irritation and should be removed as indicated.

Subcuticular sutures should be placed as deeply as possible in order to minimize the erythema and induration normally associated with absorption. Acceptable surgical practice should be followed with respect to drainage and closure of infected wounds. Avoid exposure to elevated temperatures. To avoid damaging needle points and swage areas, grasp the needle in an area one-third (1/3) to one-half (1/2) of the distance from the swaged end to the point. Reshaping needles may cause them to lose strength and be less resistant to bending and breaking. Users should exercise caution when handling surgical needles to avoid inadvertent needle sticks. Discard used needles in “sharps” containers. Adverse Reactions Due to prolonged suture absorption, mild irritation has been observed in the vaginal mucosa. Adverse effects associated with the use of synthetic absorbable sutures include wound dehiscence, failure to provide adequate wound support in closure of the sites where expansion, stretching, or distension occur, failure to provide adequate wound support in elderly, malnourished or debilitated patients or in patients suffering from conditions which may delay wound healing, infection, minimal acute inflammatory tissue reaction, localized irritation when skin sutures are left in place for greater than 7 days, suture extrusion and delayed absorption in tissue with poor blood supply, calculi formation in urinary and biliary tracts when prolonged contact with salt solutions such as urine and bile occurs, and transitory local irritation at the wound site, as well as allergic reaction to Irgacare MP (triclosan). Broken needles may result in extended or additional surgeries or residual foreign bodies. Inadvertent needle sticks with contaminated surgical needles may result in the transmission of bloodborne pathogens. How Supplied PDS Plus Antibacterial sutures are available as sterile, monofilament dyed (violet) strands in sizes 6-0 thru 1 (metric sizes 0.7-4) and sterile, monofilament undyed (clear) strands in sizes 6-0 thru 1 (metric sizes 0.7-4) in a variety of lengths, with a variety of needles. PDS Plus Antibacterial sutures are available in one, two and three dozen boxes. *Trademark ©ETHICON, INC. 2007 **Trademark of Ciba Specialty Chemical Corporation.

Essential Prescribing Information PDS* II (POLYDIOXANONE) Suture DYED and CLEAR MONOFILAMENT SYNTHETIC ABSORBABLE SUTURES, USP, except for diameter. INDICATIONS PDS II monofilament synthetic absorbable sutures are indicated for use in all types of soft tissue approximation, including use in pediatric cardiovascular tissue where growth is expected to occur, and ophthalmic surgery. PDS II suture is not indicated in adult cardiovascular tissue, microsurgery and neural tissue. These sutures are particularly useful where the combination of an absorbable suture and extended wound support (up to six weeks) is desirable. CONTRAINDICATIONS These sutures, being absorbable, are not to be used where prolonged (beyond six weeks) approximation of tissues under stress is required and are not to be used in conjunction with prosthetic devices, i.e., heart valves or synthetic grafts. WARNINGS The safety and effectiveness of PDS II (polydioxanone) sutures have not been established in neural tissue, adult cardiovascular tissue or for use in microsurgery. Under certain circumstances, notably orthopaedic procedures, immobilization by external support may be employed at the discretion of the surgeon. Do not resterilize. PRECAUTIONS The PDS II suture knots must be properly placed to be secure. As with other synthetic sutures, knot security requires the standard surgical technique of flat and square ties with additional throws if indicated by surgical circumstance and the experience of the operator. As with any suture, care should be taken to avoid damage when handling. Avoid the crushing or crimping application of surgical instruments, such as needle holders and forceps, to the strand except when grasping the free end of the suture during an instrument tie. Conjunctival and vaginal mucosal sutures remaining in place for extended periods may be associated with localized irritation and should be removed as indicated. Subcuticular sutures should be placed as deeply as possible in order to minimize the erythema and induration normally associated with absorption. Acceptable surgical practice should be followed with respect to drainage and closure of infected wounds. ADVERSE REACTIONS Due to prolonged suture absorption, some irritation and bleeding has been observed in the conjunctiva and mild irritation has been observed in the vaginal mucosa. See Package Insert for Full Prescribing Information.

Essential Prescribing Information NUROLON* Nylon Suture Nonabsorbable Surgical Suture, USP INDICATIONS NUROLON Suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures. CONTRAINDICATIONS Due to the gradual loss of tensile strength which may occur over prolonged periods in vivo, nylon suture should not be used where permanent retention of tensile strength is required. WARNINGS Users should be familiar with surgical procedures and techniques involving nonabsorbable sutures before employing NUROLON suture for wound closure, as risk of wound dehiscence may vary with the site of application and the suture material used. As with any foreign body, prolonged contact of any suture with salt solutions, such as those found in the urinary or biliary tracts, may result in calculus formation. Acceptable surgical practices should be followed for the management of infected or contaminated wounds. Do not resterilize. Discard opened packages and unused sutures. PRECAUTIONS In handling this or any other suture material, care should be taken to avoid damage from handling. Avoid crushing or crimping damage due to application of surgical instruments such as forceps or needle holders. As with any suture material, adequate knot security requires the accepted surgical technique of flat and square ties with additional throws as warranted by surgical circumstance and the experience of the surgeon. To avoid damaging needle points and swage areas, grasp the needle in an area one-third (1/3) to one-half (1/2) of the distance from the swaged end to the point. Reshaping needles may cause them to lose strength and be less resistant to bending and breaking. Users should exercise caution when handling surgical needles to avoid inadvertent needle sticks. Discard used needles in "sharps" containers. ADVERSE REACTIONS Adverse effects associated with the use of this device include wound dehiscence, gradual loss of tensile strength over time, calculi formation in urinary and biliary tracts when prolonged contact with salt solutions such as urine and bile occurs, infection, minimal acute inflammatory tissue reaction, and transitory local irritation at the wound site. Broken needles may result in extended or additional surgeries or residual foreign

bodies. Inadvertent needle sticks with contaminated surgical needles may result in the transmission of bloodborne pathogens. See Package Insert for Full Prescribing Information. *Trademark

DESCRIPTIONMONOCRYL* Plus Antibacterial (poliglecaprone 25) violetmonofilament suture is a monofilament syntheticabsorbable surgical suture prepared from a copolymer ofglycolide and epsilon-caprolactone. The suture is dyedwith D&C Violet No. 2 and contains Irgacare MP**(triclosan), a broad-spectrum antibacterial agent, at nomore than 2360 ug/m. Poliglecaprone 25 copolymer hasbeen found to be nonantigenic, nonpyrogenic and elicitsonly a slight tissue reaction during absorption.MONOCRYL Plus Antibacterial sutures are U.S.P. exceptfor diameters in the following sizes:


6-0 0.0495-0 0.0334-0 0.0453-0 0.0672-0 0.0550 0.0881 0.066

INDICATIONSMONOCRYL Plus Antibacterial sutures are indicated foruse in general soft tissue approximation and/or ligation,but not for use in cardiovascular or neurological tissues,microsurgery or ophthalmic surgery.

ACTIONSMONOCRYL Plus Antibacterial suture is a monofilamentthat elicits a minimal acute inflammatory reaction intissues and ingrowth of fibrous connective tissue.Progressive loss of tensile strength and eventualabsorption of MONOCRYL Plus Antibacterial suturesoccurs by means of hydrolysis. Absorption begins as aloss of tensile strength followed by a loss of mass.Implantation studies in rats indicate that MONOCRYL PlusAntibacterial suture retains approximately 60 to 70% ofits original strength 7 days post implantation, andapproximately 30 to 40% of its original tensile strength at14 days post implantation. All of the original tensilestrength is lost by 28 days post implantation. Absorption

1

(Poliglecaprone 25) SutureVIOLET MONOFILAMENT

SYNTHETIC ABSORBABLE SUTURE, U.S.P., EXCEPT FOR DIAMETER

DYED

of MONOCRYL Plus Antibacterial absorbable syntheticsuture is essentially complete between 91 and 119 days.


7 DAYS 60 TO 70%14 DAYS 30 TO 40%

Using zone of inhibition studies, Irgacare MP (triclosan) inMONOCRYL Plus Antibacterial suture has been shown toinhibit colonization of the suture by Staphylococcusaureus, Staphylococcus epidermidis, Methicillin ResistantS. aureus, Methicil l in Resistant S. epidermidis,Escherichia coli and Klebsiella pneumoniae which aremicroorganisms known to contribute to surgical siteinfections. Animal studies have demonstrated thatMONOCRYL Plus Antibacterial inhibits bacterialcolonization of suture after direct in vivo challenge withbacteria.CONTRAINDICATIONSThis suture, being absorbable, should not be used whereextended approximation of tissue under stress isrequired.MONOCRYL Plus Antibacterial suture should not be usedin patients with known allergic reactions to Irgacare MP(triclosan).WARNINGSUsers should be familiar with surgical procedures andtechniques involving absorbable sutures beforeemploying MONOCRYL Plus Antibacterial suture forwound closure, as risk of wound dehiscence may varywith the site of application and the suture material used.Physicians should consider the in vivo performance(under ACTIONS section) when selecting a suture for usein patients. The use of this suture may be inappropriate inelderly, malnourished, or debilitated patients, or inpatients suffering from conditions that may delay woundhealing.Do not resterilize. Discard opened packages and unusedsutures.As with any foreign body, prolonged contact of any suturewith salt solutions, such as those found in the urinary orbiliary tracts, may result in calculus formation. As anabsorbable suture, MONOCRYL Plus Antibacterial suturemay act transiently as a foreign body. Acceptable surgicalpractice should be followed for the management ofcontaminated or infected wounds.As this is an absorbable suture material, the use ofsupplemental nonabsorbable sutures should beconsidered by the surgeon in the closure of the sites

2

which may undergo expansion, stretching or distention,or which may require additional support.PRECAUTIONSSkin sutures which must remain in place longer than 7days may cause localized irritation and should be snippedoff or removed as indicated. Subcuticular sutures shouldbe placed as deeply as possible to minimize the erythemaand induration normally associated with absorption.Under some circumstances, notably orthopaedicprocedures, immobilization of joints by external supportmay be employed at the discretion of the surgeon.Consideration should be taken in the use of absorbablesutures in tissue with poor blood supply as sutureextrusion and delayed absorption may occur.In handling this or any other suture material, care shouldbe taken to avoid damage from handling. Avoid crushingor crimping damage due to application of surgicalinstruments such as forceps or needle holders.MONOCRYL Plus Antibacterial suture knots must beproperly placed to be secure. Adequate knot securityrequires the accepted surgical technique of flat andsquare ties with additional throws as warranted bysurgical circumstance and the experience of the surgeon.The use of additional throws may be particularlyappropriate when knotting monofilaments.Avoid prolonged exposure to elevated temperature.To avoid damaging needle points and swage areas, graspthe needle in an area one-third (1/3) to one-half (1/2) ofthe distance from the swaged end to the point.Reshaping needles may cause them to lose strength andbe less resistant to bending and breaking. Users shouldexercise caution when handling surgical needles to avoidinadvertent needle sticks. Discard used needles in"sharps" containers.ADVERSE REACTIONSAdverse effects associated with the use of syntheticabsorbable sutures include wound dehiscence, failure toprovide adequate wound support in closure of the siteswhere expansion, stretching, or distension occur, failureto provide adequate wound support in elderly,malnourished or debilitated patients or in patientssuffering from conditions which may delay woundhealing, infection, minimal acute inflammatory tissuereaction, localized irritation when skin sutures are left inplace for greater than 7 days, suture extrusion anddelayed absorption in tissue with poor blood supply,calculi formation in urinary and biliary tracts whenprolonged contact with salt solutions such as urine andbile occurs, and transitory local irritation at the wound

3

site, as well as allergic reaction to Irgacare MP (triclosan).Broken needles may result in extended or additionalsurgeries or residual foreign bodies. Inadvertent needlesticks with contaminated surgical needles may result inthe transmission of bloodborne pathogens.HOW SUPPLIEDMONOCRYL Plus Antibacterial sutures are available assterile, monofilament, dyed (D&C Violet No. 2) strands insizes 6-0 through 1 (metric sizes 0.7-4), in a variety oflengths, with or without needles. Various needle types areavailable.MONOCRYL Plus Antibacterial sutures are available inone, two and three dozen boxes.

a company


4




LOTBatch number


*Trademark of ETHICON, INC.**Trademark of Ciba Specialty Chemicals Corporation.©ETHICON,INC. 2005389670

2D barcode withhuman readable389670. Delete frame.

DESCRIPTIONMONOCRYL* Plus Antibacterial (poliglecaprone 25)suture is a monofilament synthetic absorbable surgicalsuture prepared from a copolymer of glycolide andepsilon-caprolactone. The suture contains Irgacare MP**(triclosan), a broad-spectrum antibacterial agent, at nomore than 2360 ug/m. Poliglecaprone 25 copolymer hasbeen found to be nonantigenic, nonpyrogenic and elicitsonly a slight tissue reaction during absorption.MONOCRYL Plus Antibacterial sutures are U.S.P. exceptfor diameters in the following sizes:


6-0 0.0495-0 0.0334-0 0.0453-0 0.0672-0 0.0550 0.0881 0.066

INDICATIONSMONOCRYL Plus Antibacterial sutures are indicated foruse in general soft tissue approximation and/or ligation,but not for use in cardiovascular or neurological tissues,microsurgery or ophthalmic surgery.

ACTIONSMONOCRYL Plus Antibacterial suture is a monofilamentthat elicits a minimal acute inflammatory reaction intissues and ingrowth of fibrous connective tissue.Progressive loss of tensile strength and eventualabsorption of MONOCRYL Plus Antibacterial suturesoccurs by means of hydrolysis. Absorption begins as aloss of tensile strength followed by a loss of mass.Implantation studies in rats indicate that MONOCRYL PlusAntibacterial suture retains approximately 50 to 60% ofits original strength 7 days post implantation, andapproximately 20 to 30% of its original tensile strength at14 days post implantation. All of the original tensilestrength is lost by 21 days post implantation. Theabsolute strength remaining 14 days post implantation

1

(Poliglecaprone 25) SutureSYNTHETIC ABSORBABLE SUTURE, U.S.P., EXCEPT FOR DIAMETER

UNDYED

meets or exceeds that historically observed with plain orchromic surgical gut sutures. Absorption of MONOCRYLPlus Antibacterial absorbable synthetic suture isessentially complete between 91 and 119 days.


7 DAYS 50 TO 60%14 DAYS 20 TO 30%

Using zone of inhibition studies, Irgacare MP (triclosan) inMONOCRYL Plus Antibacterial suture has been shown toinhibit colonization of the suture by Staphylococcusaureus, Staphylococcus epidermidis, Methicillin ResistantS. aureus, Methicil l in Resistant S. epidermidis,Escherichia coli and Klebsiella pneumoniae which aremicroorganisms known to contribute to surgical siteinfections. Animal studies have demonstrated thatMONOCRYL Plus Antibacterial inhibits bacterialcolonization of suture after direct in vivo challenge withbacteria.CONTRAINDICATIONSThis suture, being absorbable, should not be used whereextended approximation of tissue under stress isrequired, such as in fascia.MONOCRYL Plus Antibacterial suture should not be usedin patients with known allergic reactions to Irgacare MP(triclosan).WARNINGSUsers should be familiar with surgical procedures andtechniques involving absorbable sutures beforeemploying MONOCRYL Plus Antibacterial suture forwound closure, as risk of wound dehiscence may varywith the site of application and the suture material used.Physicians should consider the in vivo performance(under ACTIONS section) when selecting a suture for usein patients. The use of this suture may be inappropriate inelderly, malnourished, or debilitated patients, or inpatients suffering from conditions that may delay woundhealing.Do not resterilize. Discard opened packages and unusedsutures.As with any foreign body, prolonged contact of any suturewith salt solutions, such as those found in the urinary orbiliary tracts, may result in calculus formation. As anabsorbable suture, MONOCRYL Plus Antibacterial suturemay act transiently as a foreign body. Acceptable surgicalpractice should be followed for the management ofcontaminated or infected wounds.As this is an absorbable suture material, the use of

2

supplemental nonabsorbable sutures should beconsidered by the surgeon in the closure of the siteswhich may undergo expansion, stretching or distention,or which may require additional support.PRECAUTIONSSkin sutures which must remain in place longer than 7days may cause localized irritation and should be snippedoff or removed as indicated. Subcuticular sutures shouldbe placed as deeply as possible to minimize the erythemaand induration normally associated with absorption.Under some circumstances, notably orthopaedicprocedures, immobilization of joints by external supportmay be employed at the discretion of the surgeon.Consideration should be taken in the use of absorbablesutures in tissue with poor blood supply as sutureextrusion and delayed absorption may occur.In handling this or any other suture material, care shouldbe taken to avoid damage from handling. Avoid crushingor crimping damage due to application of surgicalinstruments such as forceps or needle holders.MONOCRYL Plus Antibacterial suture knots must beproperly placed to be secure. Adequate knot securityrequires the accepted surgical technique of flat andsquare ties with additional throws as warranted bysurgical circumstance and the experience of the surgeon.The use of additional throws may be particularlyappropriate when knotting monofilaments.Avoid prolonged exposure to elevated temperature.To avoid damaging needle points and swage areas, graspthe needle in an area one-third (1/3) to one-half (1/2) ofthe distance from the swaged end to the point.Reshaping needles may cause them to lose strength andbe less resistant to bending and breaking. Users shouldexercise caution when handling surgical needles to avoidinadvertent needle sticks. Discard used needles in"sharps" containers.ADVERSE REACTIONSAdverse effects associated with the use of syntheticabsorbable sutures include wound dehiscence, failure toprovide adequate wound support in closure of the siteswhere expansion, stretching, or distension occur, failureto provide adequate wound support in elderly,malnourished or debilitated patients or in patientssuffering from conditions which may delay woundhealing, infection, minimal acute inflammatory tissuereaction, localized irritation when skin sutures are left inplace for greater than 7 days, suture extrusion anddelayed absorption in tissue with poor blood supply,calculi formation in urinary and biliary tracts when

3

prolonged contact with salt solutions such as urine andbile occurs, and transitory local irritation at the woundsite, as well as allergic reaction to Irgacare MP (triclosan).Broken needles may result in extended or additionalsurgeries or residual foreign bodies. Inadvertent needlesticks with contaminated surgical needles may result inthe transmission of bloodborne pathogens.HOW SUPPLIEDMONOCRYL Plus Antibacterial sutures are available assterile, monofilament, undyed strands in sizes 6-0through 1 (metric sizes 0.7-4), in a variety of lengths, withor without needles. Various needle types are available.MONOCRYL Plus Antibacterial sutures are available inone, two and three dozen boxes.

a company


4




LOTBatch number


*Trademark of ETHICON, INC.**Trademark of Ciba Specialty Chemicals Corporation.©ETHICON,INC. 2005389680

2D barcode withhuman readable389680 Delete frame.

SIMBOLI USATI SULL’ETICHETTA

= Monouso

= Da usarsi entro Anno & Mese

= Il prodotto è sterile se la confezione non è aperta o danneggiata. Metodo di Sterilizzazione – Ossido di Etilene

0086 = Marchio CE e numero di identificazione dell'Organismo notificato. Il prodotto è conforme ai requisiti essenziali dellaDirettiva CEE 93/42 sui Dispositivi Medici

= Numero di Lotto

= Leggere attentamente il foglio illustrativo.

GR Istruzioni per l'uso I Gebruiksaanwijzing NL

MONOCRYL®¶√§À°§À∫∞¶ƒ√¡∏ 25

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PAMMA

MONOCRYL®POLIGLECAPRONE 25

SUTURA STERILE, SINTETICA, ASSORBIBILE


STERIEL, SYNTHETISCH, RESORBEERBAAR

HECHTMATERIAAL

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∞¡∆∂¡¢∂π•∂π™A˘Ù¿ Ù· Ú¿ÌÌ·Ù·, ‚·ÌÌ¤Ó· Î·È ¿‚·Ê·, Î·ıfiÛÔÓ Â›Ó·È ·ÔÚÚÔÊ‹ÛÈÌ· ‰ÂÓ Ú¤ÂÈ Ó·¯ÚËÛÈÌÔÔÈÔ‡ÓÙ·È ÂÎÂ› fiÔ˘ ··ÈÙÂ›Ù·È ÂÎÙÂÙ·Ì¤ÓË Û˘ÁÎÚ¿ÙËÛË ÂÓ Â·Ê‹ ÙˆÓ ÈÛÙÒÓ˘fi Ù¿ÛË. ∆· ¿‚·Ê· Ú¿ÌÌ·Ù· ‰ÂÓ Ú¤ÂÈ Ó· ¯ÚËÛÈÌÔÔ‡ÓÙ·È ÁÈ· ÎÏÂ›ÛÈÌÔ ÙÔ˘ÎÔÈÏÈ·ÎÔ‡ ÙÔÈ¯ÒÌ·ÙÔ˜ ‹ ÁÈ· Û˘ÚÚ·Ê‹ ·ÔÓÂ‡ÚˆÛË˜.

¶ƒ√∂π¢√¶√π∏™∂π™ / ¶ƒ√ºÀ§∞•∂π™ / ∞§§∏§∂¶π¢ƒ∞™∂π™∏ ·ÛÊ¿ÏÂÈ· Î·È ·ÔÙÂÏÂÛÌ·ÙÈÎfiÙËÙ· ÙˆÓ Ú·ÌÌ¿ÙˆÓ MONOCRYL® ‰ÂÓ ¤¯ÂÈıÂÌÂÏÈˆıÂ› ÛÙ· ·ÎfiÏÔ˘ı· Â‰›·: ÓÂ˘ÚÈÎfi˜ ÈÛÙfi˜, Î·Ú‰È·ÁÁÂÈ·Îfi˜ ÈÛÙfi˜,ÌÈÎÚÔ¯ÂÈÚÔ˘ÚÁÈÎ‹ Î·È ÔÊı·ÏÌÔÏÔÁÈÎ‹ ¯ÂÈÚÔ˘ÚÁÈÎ‹. √È ¯Ú‹ÛÙÂ˜ Ú¤ÂÈ Ó· Â›Ó·ÈÂÍÔÈÎÂÈˆÌ¤ÓÔÈ ÌÂ ¯ÂÈÚÔ˘ÚÁÈÎ¤˜ ‰È·‰ÈÎ·Û›Â˜ Î·È ÙÂ¯ÓÈÎ¤˜ Ô˘ ÂÚÈÏ·Ì‚¿ÓÔ˘Ó·ÔÚÚÔÊ‹ÛÈÌ· Ú¿ÌÌ·Ù· ÚÈÓ ¯ÚËÛÈÌÔÔÈ‹ÛÔ˘Ó ÙÔ ª√¡√CRYL® ÁÈ· ÎÏÂ›ÛÈÌÔÏËÁÒÓ, Î·ıfiÛÔÓ Ô Î›Ó‰˘ÓÔ˜ ‰È¿ÓÔÈÍË˜ ÙË˜ ÏËÁ‹˜ ÌÔÚÂ› Ó· ÔÈÎ›ÏÏÂÈ ·Ó¿ÏÔÁ· ÌÂ ÙËı¤ÛË ÙË˜ ÂÊ·ÚÌÔÁ‹˜ Î·È ÙÔÓ Ù‡Ô ÙÔ˘ Ú¿ÌÌ·ÙÔ˜ Ô˘ ̄ ÚËÛÈÌÔÔÈ‹ıËÎÂ. √È ̄ ÂÈÚÔ‡ÚÁÔÈÚ¤ÂÈ Ó· Ï·Ì‚¿ÓÔ˘Ó ˘fi„ÈÓ ÙËÓ in vivo ·fi‰ÔÛË (ÛÙÔ ÎÂÊ¿Ï·ÈÔ ∞¶√¢√™∏) fiÙ·ÓÂÈÏ¤ÁÔ˘Ó Ù‡Ô Ú¿ÌÌ·ÙÔ˜. ∞˘Ùfi ÙÔ Ú¿ÌÌ· ÌÔÚÂ› Ó· Â›Ó·È ·Î·Ù¿ÏÏËÏÔ ÛÂËÏÈÎÈˆÌ¤ÓÔ˘˜, Î·¯ÂÎÙÈÎÔ‡˜ ‹ ÂÍ·ÛıÂÓËÌ¤ÓÔ˘˜ ·ÛıÂÓÂ›˜ ‹ ÛÂ ·ÛıÂÓÂ›˜ Ô˘‚Ú›ÛÎÔÓÙ·È ̆ fi ÙËÓ Â›‰Ú·ÛË Û˘ÓıËÎÒÓ Ô˘ ÌÔÚÂ› Ó· Î·ı˘ÛÙÂÚ‹ÛÔ˘Ó ÙËÓ ÂÔ‡ÏˆÛËÙË˜ ÏËÁ‹˜. √ˆ˜ Î·È ÌÂ Î¿ıÂ Í¤ÓÔ ÛÒÌ·, Ë ·Ú·ÙÂÙ·Ì¤ÓË Â·Ê‹ Î¿ıÂ Ú¿ÌÌ·ÙÔ˜ ÌÂ‰È·Ï‡Ì·Ù· ·Ï¿ÙˆÓ, fiˆ˜ ·˘Ù¿ Ô˘ ‚Ú›ÛÎÔÓÙ·È ÛÙÔ Ô˘ÚÔÔÈËÙÈÎfi Î·È ÛÙÈ˜ ¯ÔÏËÊfiÚÂ˜Ô‰Ô‡˜, ÌÔÚÂ› Ó· Ô‰ËÁ‹ÛÂÈ ÛÂ ÏÈı›·ÛË. ™·Ó ·ÔÚÚÔÊ‹ÛÈÌÔ Ú¿ÌÌ· ÙÔ ª√¡√CRYL®

ÌÔÚÂ› Ó· ‰Ú¿ÛÂÈ ·ÚÔ‰ÈÎ¿ Û·Ó Í¤ÓÔ ÛÒÌ·. ∏ Î·ıÈÂÚˆÌ¤ÓË ¯ÂÈÚÔ˘ÚÁÈÎ‹ Ú·ÎÙÈÎ‹Ú¤ÂÈ Ó· ·ÎÔÏÔ˘ıÂ›Ù·È ÁÈ· ÙÔÓ ¯ÂÈÚÈÛÌfi ÌÔÏ˘ÛÌ¤ÓˆÓ ‹ ÚÔÛ‚Â‚ÏËÌ¤ÓˆÓ ÏËÁÒÓ.∫·ıÒ˜ ·˘Ùfi Â›Ó·È ¤Ó· ·ÔÚÚÔÊ‹ÛÈÌÔ ˘ÏÈÎfi Ú·Ê‹˜, Ú¤ÂÈ Ó· ÂÍÂÙ·ÛıÂ› ·fi ÙÔ¯ÂÈÚÔ‡ÚÁÔ Ë ÂÚ›ÙˆÛË ̄ Ú‹ÛË˜ ÚfiÛıÂÙˆÓ, ÌË ·ÔÚÚÔÊ‹ÛÈÌˆÓ Ú·ÌÌ¿ÙˆÓ ÁÈ· ÎÏÂ›ÛÈÌÔÏËÁÒÓ ÛÂ ı¤ÛÂÈ˜ Ô˘ ÌÔÚÔ‡Ó Ó· ˘ÔÛÙÔ‡Ó ‰È·ÛÙÔÏ‹, ¤ÎÙ·ÛË ‹ ‰ÈfiÁÎˆÛË, ‹ ı¤ÛÂÈ˜Ô˘ Â›Ó·È Èı·Ófi Ó· ··ÈÙÔ‡Ó ÚfiÛıÂÙË ˘ÔÛÙ‹ÚÈÍË. √È Ú·Ê¤˜ ‰¤ÚÌ·ÙÔ˜, ÔÈ ÔÔ›Â˜·Ú·Ì¤ÓÔ˘Ó Ï¤ÔÓ ÙˆÓ 7 ËÌÂÚÒÓ Â›Ó·È ‰˘Ó·ÙfiÓ Ó· ÚÔÎ·Ï¤ÛÔ˘Ó ÂÓÙÔÈÛÌ¤ÓÔÂÚÂıÈÛÌfi Î·È Ú¤ÂÈ Ó· ÎÔÔ‡Ó ÌÂ „·Ï›‰È ‹ Ó· ·Ê·ÈÚÂıÔ‡Ó. √È ˘Ô‰ÂÚÌÈÎ¤˜ Ú·Ê¤˜Ú¤ÂÈ Ó· ÙÔÔıÂÙÔ‡ÓÙ·È fiÛÔ ‰˘Ó·ÙfiÓ ‚·ı‡ÙÂÚ·, ÒÛÙÂ Ó· ÂÏ·¯ÈÛÙÔÔÈÂ›Ù·È ÙÔÂÚ‡ıËÌ· Î·È Ë ÛÎÏ‹Ú˘ÓÛË, Ô˘ Û˘Ó‹ıˆ˜ Û˘Ó‰¤ÔÓÙ·È ÌÂ ÙËÓ ‰È·‰ÈÎ·Û›· ÙË˜·ÔÚÚfiÊËÛË˜. ™Â ÔÚÈÛÌ¤ÓÂ˜ ÂÚÈÙÒÛÂÈ˜, Î˘Ú›ˆ˜ ÔÚıÔÂ‰ÈÎ¤˜ ÂÂÌ‚¿ÛÂÈ˜, Èı·Ó‹·ÎÈÓËÙÔÔ›ËÛË ÙˆÓ ·ÚıÚÒÛÂˆÓ ÌÂ ÂÍˆÙÂÚÈÎfi ̆ ÔÛÙ‹ÚÈÁÌ· ¤ÁÎÂÈÙ·È ÛÙËÓ ‰È·ÎÚÈÙÈÎ‹Â˘¯¤ÚÂÈ· ÙÔ˘ ¯ÂÈÚÔ˘ÚÁÔ‡. ∏ ¯Ú‹ÛË ÙˆÓ ·ÔÚÚÔÊ‹ÛÈÌˆÓ Ú·ÌÌ¿ÙˆÓ ÛÂ ÈÛÙÔ‡˜ ÌÂÏËÌÌÂÏ‹ ·ÈÌ¿ÙˆÛË Ú¤ÂÈ Ó· ÙÂıÂ› ˘Ô ÂÍ¤Ù·ÛË, Î·ıÒ˜ ˘¿Ú¯ÂÈ ÂÚ›ÙˆÛË Ó·Û˘Ì‚Â› ÂÍÒıËÛË ÙˆÓ Ú·ÌÌ¿ÙˆÓ Î·È Î·ı˘ÛÙÂÚËÌ¤ÓË ·ÔÚÚfiÊËÛË. ∫·Ù¿ ÙË ̄ Ú‹ÛË ·˘ÙÔ‡‹ ÔÔÈÔ˘‰‹ÔÙÂ ¿ÏÏÔ˘ ̆ ÏÈÎÔ‡ Ú·Ê‹˜, Ú¤ÂÈ Ó· ·ÔÊÂ‡ÁÂÙ·È Ë ÚfiÎÏËÛË ÊıÔÚÒÓ Î·Ù¿ÙÔÓ ¯ÂÈÚÈÛÌfi ÙÔ˘˜. ∞ÔÊÂ‡ÁÂÙÂ ÙÈ˜ ÊıÔÚ¤˜ Ô˘ ÔÊÂ›ÏÔÓÙ·È ÛÂ Û˘ÓÙÚÈ‚‹ ‹ ÂÏ›ÎˆÛËÏfiÁˆ ¯Ú‹ÛË˜ ¯ÂÈÚÔ˘ÚÁÈÎÒÓ ÂÚÁ·ÏÂ›ˆÓ, fiˆ˜ ÔÈ Ï·‚›‰Â˜ Î·È Ù· ‚ÂÏÔÓÔÎ¿ÙÔ¯·. ∏Â·ÚÎ‹˜ ·ÛÊ¿ÏÂÈ· ÙˆÓ ÎfiÌˆÓ ··ÈÙÂ› ÙËÓ Î·ıÈÂÚˆÌ¤ÓË ¯ÂÈÚÔ˘ÚÁÈÎ‹ ÙÂ¯ÓÈÎ‹ ÙˆÓÂ›Â‰ˆÓ Î·È ÙÂÙÚ¿ÁˆÓˆÓ ‰ÂÛÌÒÓ ÌÂ ÂÈÏ¤ÔÓ Ú¿ÌÌ·Ù·, fiˆ˜ ˘Ô‰ÂÈÎÓ‡ÂÈ ÙÔ

¯ÂÈÚÔ˘ÚÁÈÎfi ÂÚÈÛÙ·ÙÈÎfi Î·È Ë ÂÌÂÈÚ›· ÙÔ˘ ¯ÂÈÚÔ‡ÚÁÔ˘. ∏ ÂÊ·ÚÌÔÁ‹ ÂÈÏ¤ÔÓÚ·ÊÒÓ ÌÔÚÂ› Ó· Â›Ó·È È‰È·›ÙÂÚ· ¯Ú‹ÛÈÌË Î·Ù¿ ÙÔ ‰¤ÛÈÌÔ ÔÔÈÔ˘‰‹ÔÙÂÌÔÓfiÎÏˆÓÔ˘ Ú¿ÌÌ·ÙÔ˜. ¶Ú¤ÂÈ Ó· ‰›ÓÂÙ·È ÚÔÛÔ¯‹ ÒÛÙÂ Ó· ·ÔÊÂ‡ÁÔÓÙ·È ÔÈÊıÔÚ¤˜ fiÙ·Ó ¯ÚËÛÈÌÔÔÈÔ‡ÓÙ·È ¯ÂÈÚÔ˘ÚÁÈÎ¤˜ ‚ÂÏfiÓÂ˜. ¶È¿ÛÙÂ ÙËÓ ‚ÂÏfiÓ· ÛÂ ÌÈ·ÂÚÈÔ¯‹ Ô˘ Ó· Î˘Ì·›ÓÂÙ·È ·Ô ¤Ó· ÙÚ›ÙÔ (1/3) ¤ˆ˜ ÙÔ ÌÈÛfi (1/2) ÙË˜ ·fiÛÙ·ÛË˜ÙË˜ Ì‡ÙË˜ ÙË˜ ‚ÂÏfiÓ·˜ ·Ô ÙÔ ÛËÌÂ›Ô Ô˘ Â›Ó·È ÚÔÛ·ÚÌÔÛÌ¤ÓÔ ÙÔ Ú¿ÌÌ·. ¶È¿ÛÈÌÔÛÙËÓ ÂÚÈÔ¯‹ ÙË˜ Ì‡ÙË˜ ÙË˜ ‚ÂÏfiÓ·˜ ÌÔÚÂ› Ó· ‚Ï¿„ÂÈ ÙËÓ ‰ÈÂÈÛ‰˘ÙÈÎ‹ÈÎ·ÓfiÙËÙ· Î·È Ó· ÚÔÎ·Ï¤ÛÂÈ ıÚ·‡ÛË ÙË˜ ‚ÂÏfiÓ·˜. ¶È¿ÛÈÌÔ ÛÙÔ ¿ÏÏÔ ¿ÎÚÔ ‹ ÙÔÛËÌÂ›Ô Ô˘ Â›Ó·È ÚÔÛ·ÚÌÔÛÌ¤ÓÔ ÙÔ Ú¿ÌÌ· ÌÔÚÂ› Ó· ÚÔÎ·Ï¤ÛÂÈ Ï‡ÁÈÛÌ· ‹Û¿ÛÈÌÔ. ∂·Ó·ÊÔÚ¿ ÙË˜ Ï˘ÁÈÛÌ¤ÓË˜ ‚ÂÏfiÓ·˜ ÛÙËÓ ·Ú¯ÈÎ‹ Î·Ù¿ÛÙ·ÛË ÌÔÚÂ› Ó·Ô‰ËÁ‹ÛÂÈ ÛÂ ·ÒÏÂÈ· ÙË˜ ·ÓÙÔ¯‹˜ ÙË˜ Î·È ÙË˜ ·ÓÙ›ÛÙ·ÛË˜ ÙË˜ ÛÙÔ Ï‡ÁÈÛÌ· Î·ÈÛÙÔ Û¿ÛÈÌÔ. √È ¯Ú‹ÛÙÂ˜ ı· Ú¤ÂÈ Ó· Â›Ó·È ÚÔÛÂÎÙÈÎÔ› fiÙ·Ó ¯ÂÈÚ›˙ÔÓÙ·È¯ÂÈÚÔ˘ÚÁÈÎ¤˜ ‚ÂÏfiÓÂ˜ Î·È Ó· ·ÔÊÂ‡ÁÔ˘Ó Ù· ÙÚ˘‹Ì·Ù· ·Ô ·ÚfiÛÂÎÙË ¯Ú‹ÛË.∞ÔÚÚ›ÙÂÙÂ ÙÈ˜ ¯ÚËÛÈÌÔÔÈËÌ¤ÓÂ˜ ‚ÂÏfiÓÂ˜ ÛÙÔ˘˜ Î¿‰Ô˘˜ ÁÈ· ·È¯ÌËÚ¿·ÓÙÈÎÂ›ÌÂÓ·.

¶∞ƒ∂¡∂ƒ°∂π∂™√È ·ÚÂÓ¤ÚÁÂÈÂ˜ Ô˘ Û˘Ó‰¤ÔÓÙ·È ÌÂ ÙËÓ ¯Ú‹ÛË ·˘ÙÔ‡ ÙÔ˘ ÚÔ˚fiÓÙÔ˜ ÂÚÈ-Ï·Ì‚¿ÓÔ˘Ó: ·ÚÔ‰ÈÎfi ÙÔÈÎfi ÂÚÂıÈÛÌfi ÛÙË ı¤ÛË ÙË˜ ÏËÁ‹˜, ·ÚÔ‰ÈÎ‹ÊÏÂÁÌÔÓÒ‰Ë ·ÓÙ›‰Ú·ÛË ÛÂ Í¤ÓÔ ÛÒÌ·, ÂÚ‡ıËÌ· Î·È ÛÎÏ‹Ú˘ÓÛË Î·Ù¿ ÙË‰È·‰ÈÎ·Û›· ·ÔÚÚfiÊËÛË˜ ÙˆÓ ̆ Ô‰ÂÚÌÈÎÒÓ Ú·ÌÌ¿ÙˆÓ. Ÿˆ˜ fiÏ· Ù· Í¤Ó· ÛÒÌ·Ù·ÙÔ MONOCRYL® ÌÔÚÂ› Ó· ÂÓÈÛ¯‡ÛÂÈ ÌÈ· ÚÔ¸¿Ú¯Ô˘Û· ÌfiÏ˘ÓÛË.

∞¶√™∆∂πƒø™∏∆· Ú¿ÌÌ·Ù· ª√¡√CRYL® ·ÔÛÙÂÈÚÒÓÔÓÙ·È ÌÂ ·¤ÚÈÔ ·Èı˘ÏÂÓÔÍÂ›‰ÈÔ. ªËÓ Ù·Â·Ó·ÔÛÙÂÈÚÒÓÂÙÂ. ªËÓ Ù· ¯ÚËÛÈÌÔÔÈÂ›ÙÂ Â·Ó Ë Û˘ÛÎÂ˘·Û›· ¤¯ÂÈ ·ÓÔÈ¯ıÂ› ‹Î·Ù·ÛÙÚ·ÊÂ›. ∞ÔÚÚ›ÙÂÙÂ Ù· ·ÓÔÈÁÌ¤Ó·, ÌË ¯ÚËÛÈÌÔÔÈËÌ¤Ó· Ú¿ÌÌ·Ù·.

∞¶√£∏∫∂À™∏

¶∂ƒπ°ƒ∞º∏ ∆Ô ª√¡√CRYL® Â›Ó·È ¤Ó· ·ÔÛÙÂÈÚˆÌ¤ÓÔ Û˘ÓıÂÙÈÎfi ·ÔÚÚÔÊ‹ÛÈÌÔ ÌÔÓfiÎÏˆÓÔÚ¿ÌÌ·, ·Ú·ÛÎÂ˘·ÛÌ¤ÓÔ ·fi ¤Ó· Û˘ÌÔÏ˘ÌÂÚ¤˜ ÙÔ˘ ÁÏ˘ÎÔÏÈ‰›Ô˘ Î·È ÙË˜ Â-Î·ÚÔÏ·ÎÙfiÓË˜. √ ÂÌÂÈÚÈÎfi˜ ÌÔÚÈ·Îfi˜ Ù‡Ô˜ ÙÔ˘ ÔÏ˘ÌÂÚÔ‡˜ Â›Ó·È(C2H2O2)m(C6H10O2)n. ∂¯ÂÈ ‚ÚÂıÂ› fiÙÈ ÙÔ Û˘ÌÔÏ˘ÌÂÚ¤˜ ÔÏ˘ÁÏ˘Î·ÚfiÓË 25 ‰ÂÓ ¤¯ÂÈ ·ÓÙÈÁÔÓÈÎ¤˜È‰ÈfiÙËÙÂ˜, ‰ÂÓ Â›Ó·È ˘ÚÂÙÔÁfiÓÔ Î·È ÂÌÊ·Ó›˙ÂÈ Ì¤ÙÚÈ· ÌfiÓÔ ÈÛÙÈÎ‹ ·ÓÙ›‰Ú·ÛËÎ·Ù¿ÙËÓ ·ÔÚÚfiÊËÛË. ∆· Ú¿ÌÌ·Ù· ª√¡√CRYL® ‚¿ÊÔÓÙ·È ÌÂ ÙËÓ ÚÔÛı‹ÎË ÈÒ‰Ô˘˜ D&C ÓÔ‡ÌÂÚÔ 2(∞ÚÈıÌfi˜ ‰Â›ÎÙË˜ ¯ÚÒÌ·ÙÔ˜ 60725) Î·Ù¿ ÙÔÓ ÔÏ˘ÌÂÚÈÛÌfi. ∂›Ó·È Â›ÛË˜ ‰È·ı¤ÛÈÌ·¿‚·Ê·. ∆· Ú¿ÌÌ·Ù· ª√¡√CRYL® ‰È·Ù›ıÂÓÙ·È ÛÂ ÌÈ· ÔÈÎÈÏ›· ‰È·ÌÂÙÚËÌ¿ÙˆÓÎ·È ÌËÎÒÓ, ¯ˆÚ›˜ ‚ÂÏfiÓ· ‹ ÚÔÛ·ÚÌÔÛÌ¤Ó· ÛÂ ·ÓÔÍÂ›‰ˆÙÂ˜ ·ÙÛ¿ÏÈÓÂ˜ ‚ÂÏfiÓÂ˜‰È·ÊfiÚˆÓ Ù‡ˆÓ Î·È ÌÂÁÂıÒÓ. √È ‚ÂÏfiÓÂ˜ ÌÔÚÂ› Ó· Â›Ó·È ÌfiÓÈÌ· ÚÔÛ·ÚÌÔÛÌ¤ÓÂ˜‹ ÂÏÂÁ¯fiÌÂÓË˜ ·ÂÏÂ˘ı¤ÚˆÛË˜ (CONTROL RELEASE), Ô˘ ÂÈÙÚ¤ÂÈ ÛÙÈ˜ ‚Â-ÏfiÓÂ˜ Ó· ·ÔÛÒÓÙ·È ·ÓÙ› Ó· Îfi‚ÔÓÙ·È. ¶Ï‹ÚÂÈ˜ ÏÂÙÔÌ¤ÚÂÈÂ˜ ÙË˜ ÔÈÎÈÏ›·˜ ÙˆÓÚÔ˚fiÓÙˆÓ ÂÚÈ¤¯ÔÓÙ·È ÛÙÔÓ Î·Ù¿ÏÔÁÔ. ∆Ô ª√¡√CRYL® ÏËÚÂ› fiÏÂ˜ ÙÈ˜ ÚÔ‰È·ÁÚ·Ê¤˜ ÙË˜ ∂˘Úˆ·˚Î‹˜ º·ÚÌ·ÎÔÔÈ›·˜ÁÈ· Û˘ÓıÂÙÈÎ¿ ·ÔÚÚÔÊ‹ÛÈÌ· ÌÔÓfiÎÏˆÓ· Ú¿ÌÌ·Ù· Î·È ÙÈ˜ ÚÔ‰È·ÁÚ·Ê¤˜ ÙË˜·ÓÙ›ÛÙÔÈ¯Ë˜ ÙˆÓ ∏¶∞ ÁÈ· ·ÔÚÚÔÊ‹ÛÈÌ· ¯ÂÈÚÔ˘ÚÁÈÎ¿ Ú¿ÌÌ·Ù·, ÂÎÙfi˜ ·fi ÌÈ·ÌÈÎÚ‹ ˘¤Ú‚·ÛË ÛÙË ‰È¿ÌÂÙÚÔ.

∂¡¢∂π•∂π™∆· Ú¿ÌÌ·Ù· ª√¡√CRYL® ÂÓ‰Â›ÎÓ˘ÓÙ·È ÁÈ· ÁÂÓÈÎ‹ ¯Ú‹ÛË ÛÂ Û˘ÁÎÚ¿ÙËÛËÌ·Ï·ÎÒÓ ÈÛÙÒÓ ÛÂ Â·Ê‹ Î·È/‹ Û‡Ó‰ÂÛË, fiÔ˘ ÂÓ‰Â›ÎÓ˘Ù·È ·ÔÚÚÔÊ‹ÛÈÌÔ ˘ÏÈÎfi.

∂º∞ƒª√°∏∏ ÂÈÏÔÁ‹ Î·È ÂÌÊ‡ÙÂ˘ÛË ÙˆÓ Ú·ÌÌ¿ÙˆÓ ÂÍ·ÚÙ¿Ù·È ·fi ÙËÓ Î·Ù¿ÛÙ·ÛË ÙÔ˘·ÛıÂÓÔ‡˜, ÙË ¯ÂÈÚÔ˘ÚÁÈÎ‹ ÂÌÂÈÚ›·, ÙË ¯ÂÈÚÔ˘ÚÁÈÎ‹ ÙÂ¯ÓÈÎ‹ Î·È ÙÔ Ì¤ÁÂıÔ˜ ÙË˜ÏËÁ‹˜.

∞¶√¢√™∏To MONOCRYL® ÂÌÊ·Ó›˙ÂÈ ÌÈ· ÂÏ¿¯ÈÛÙË ·Ú¯ÈÎ‹ ÊÏÂÁÌÔÓÒ‰Ë ÈÛÙÈÎ‹ ·ÓÙ›‰Ú·ÛËÎ·È ·ÓÙÈÎ·ı›ÛÙ·Ù·È ÙÂÏÈÎ¿ ·Ô ¤Ó· ÂÈ ÙfiÔ˘ ·Ó·Ù˘ÁÌ¤ÓÔ ÈÓÒ‰Ë Û˘Ó‰ÂÙÈÎfi ÈÛÙfi.∏ ÚÔÔ‰Â˘ÙÈÎ‹ ·ÒÏÂÈ· ÙË˜ ·ÓÙÔ¯‹˜ ÛÙËÓ ¤ÏÍË Î·È Ë ÙÂÏÈÎ‹ ·ÔÚÚfiÊËÛË ÙˆÓÚ·ÌÌ¿ÙˆÓ MONOCRYL® Ú·ÁÌ·ÙÔÔÈÂ›Ù·È Ì¤Ûˆ ˘‰ÚfiÏ˘ÛË˜, fiÔ˘ ÙÔ ÔÏ˘ÌÂÚ¤˜·ÔÈÎÔ‰ÔÌÂ›Ù·È ÚÔ˜ ·‰ÈÈÎfi ÔÍ‡, ÙÔ ÔÔ›Ô ÛÙË Û˘Ó¤¯ÂÈ· ·ÔÚÚÔÊ¿Ù·È Î·ÈÌÂÙ·‚ÔÏ›˙ÂÙ·È ÛÙÔ ÛÒÌ·. ∏ ·ÔÚÚfiÊËÛË ·Ú¯›˙ÂÈ ˆ˜ ·ÒÏÂÈ· ·ÓÙÔ¯‹˜ ÛÙËÓ ¤ÏÍË·ÎÔÏÔ˘ıÔ‡ÌÂÓË ·Ô ·ÒÏÂÈ· Ì¿˙·˜. ªÂÏ¤ÙÂ˜ ÂÌÊ‡ÙÂ˘ÛË˜ ÛÂ ·ÚÔ˘Ú·›Ô˘˜ ‰Â›¯ÓÔ˘Ó

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DESCRIZIONEIl MONOCRYL® è un tipo di sutura monofilamento sintetica sterile e assorbibileper uso chirurgico costituita da un copolimero composto di glicolide ed Â-capro-lattone. La formula empirica del copolimero è (C2H2O2)m (C6H10O2)n.Il Poliglecaprone 25 è non-antigenico, non-pirogenico, e provoca solamenteuna leggera reazione tissutale durante l’assorbimento.Le suture di MONOCRYL® sono colorate con violetto D&C n. 2 (C.I. n. 60725)aggiunto durante il processo di polimerizzazione. Sono disponibili anche suturenon colorate.Le suture di MONOCRYL® sono disponibili in diversi calibri e lunghezze, siasenza ago che montate su aghi di acciaio inossidabile di vari tipi e dimensioni.Gli aghi possono essere fissati al filo o uniti con un sistema di distacco control-lato (Control Release), che permette di rimuovere l’ago dalla sutura, evitando direcidere il filo all’altezza dell’attacco con lo stesso.Informazioni dettagliate sull’intera gamma disponibile, sono contenute nel cata-logo prodotti.Il MONOCRYL® è conforme ai requisiti delle monografie della FarmacopeaEuropea e degli Stati Uniti per le Suture Chirurgiche assorbibili, eccetto per unleggero surdimensionamento dello spessore.

INDICAZIONIIl MONOCRYL® è indicato per suture e legature di tessuti molli, nei casi in cui siaindicato l’uso di suture in materiale assorbibile.

APPLICAZIONILe suture devono essere scelte ed impiantate tenendo presenti le condizioni delpaziente, l’esperienza dell’operatore, la tecnica chirurgica adottata e le dimen-sioni della ferita da suturare.

PRESTAZIONIIl MONOCRYL® provoca solo una minima o moderata reazione infiammatoriainiziale nei tessuti, e viene gradualmente rimpiazzato da tessuto connettivo fi-broso neo-formato.La progressiva perdita di resistenza tensile della sutura con conseguente assor-bimento finale avviene per idrolisi del copolimero che si degrada ad acido adipicoche è successivamente assorbito e metabolizzato dall’organismo.

L’assorbimento comincia con la perdita di resistenza tensile seguita da perdita dimateriale.Studi di impianti in ratti hanno dimostrato il seguente profilo:

VIOLETTO NON COLORATO Post-impianto Resistenza Post-impianto Resistenza

originale residua originale residua(valori approssimativi) (valori approssimativi)

7 giorni 60% 7 giorni 50%14 giorni 30% 14 giorni 20%La resistenza tensile si azzera del tutto La resistenza tensile si azzera del tuttodopo 28 giorni dall’impianto. dopo 21 giorni dall’impianto.

L’assorbimento si completa tra 90 e 120 giorni.

CONTROINDICAZIONIQueste suture, (violetto e non colorate) essendo assorbibili, non debbono essereutilizzate quando sia necessaria la rimarginazione di estese aree di tessuto sottotensione.Le suture di MONOCRYL® non colorate non devono essere usate per suture addo-minali di tessuto fasciale.

AVVERTENZE / PRECAUZIONI / INTERAZIONILa sicurezza ed efficacia delle suture MONOCRYL® non sono ancora state valuta-te nelle seguenti applicazioni: chirurgia del tessuto nervoso e cardiovascolare, micro-chirurgia e chirurgia oftalmica. Prima di utilizzare MONOCRYL® per la sutura delleferite, l’operatore deve aver già familiarizzato con le procedure chirurgiche e conl’utilizzo delle suture assorbibili, poiché il rischio di deiscenza può variare, infatti, aseconda della localizzazione della ferita e del materiale da sutura usato. Quandosceglie un tipo di sutura il chirurgo dovrebbe prendere in considerazione le presta-zioni in vivo descritte più sopra nella sezione “prestazioni”. Queste suture possononon essere indicate nei pazienti anziani, in quelli malnutriti o debilitati, o in pazientiaffetti da condizioni che possono rallentare la cicatrizzazione di ferite. Come avvieneper ogni corpo estraneo, il contatto prolungato di ogni tipo di sutura con soluzionisaline quali quelle presenti nei tratti urinario e biliare, può dar luogo a formazioni dicalcoli. Quale sostanza assorbibile, la sutura di MONOCRYL® può agire come cor-po estraneo. È necessario attenersi alla normale pratica chirurgica in tema di dre-naggio ed approssimazione dei tessuti infetti o contaminati. Dato che MONOCRYL®

è un materiale assorbibile, l’uso di suture addizionali non assorbibili deve esserepreso in considerazione dal chirurgo nella rimarginazione di ferite che potrebbero inseguito subire espansione, stiramento o distensione, o che richiedano supportosupplementare. Suture cutanee che rimangano in situ più a lungo di sette giornipotrebbero causare irritazione localizzata e, se necessario, dovrebbero quindi esse-re tolte. Le suture sottocutanee devono essere impiantate il più profondamente pos-sibile onde minimizzare la formazione di eritema ed indurimento normalmenteassociati con il procedimento di assorbimento. In determinate circostanze e spe-cialmente in casi di procedimenti ortopedici, l’immobilizzazione di articolazioni medi-ante supporti esterni può essere applicata a giudizio del chirurgo. Bisogna fare at-tenzione quando si usano suture assorbibili in tessuti con scarsa irrorazione sangui-gna poiché possono verificarsi estrusione delle suture e rallentato assorbimentodelle stesse. Nell’utilizzazione di MONOCRYL®, così come per ogni altro materialeda sutura, bisogna far attenzione a non danneggiare le suture stesse. Evitare distringere e/o schiacciare i fili con strumenti chirurgici quali pinze e porta aghi. Come

per altri materiali da sutura, allo scopo di garantire una adeguata sicurezza del nodo,si consiglia di applicare l’usuale tecnica chirurgica del nodo piatto o quadrato, coneventuali nodi addizionali, a seconda di quanto richiesto dalla specifica circostanzachirurgica e dall’esperienza dell’operatore. Nel maneggiare gli aghi da chirurgia, bi-sogna far attenzione a non danneggiarli. L’ago, deve essere afferrato in un puntosituato tra circa un terzo e la metà della distanza tra la cruna e la punta. Se l’agoviene afferrato troppo vicino alla punta, si potrebbe impedirne la penetrazione e/ocausarne la rottura. Se viene invece afferrato vicino alla cruna, si potrebbe piegare ospezzare. Cercare di modificare la forma dell’ago, potrebbe diminuirne la resistenzaalla piegatura e alla rottura. Chi maneggia aghi da chirurgia, deve fare attenzione anon ferirsi pungendosi. Eliminare gli aghi usati, gettandoli negli appositi contenitori.

EFFETTI INDESIDERATIIndesiderabili reazioni associate all’uso di questo prodotto, sono rappresentate dainiziali reazioni infiammatorie tissutali di minima entità e locale irritazione transitoriadella ferita. Come tutti i corpi estranei, la sutura MONOCRYL® può far peggiorare unapreesistente infezione.

STERILITÀMONOCRYL® è sterilizzato ad ossido di etilene. Non risterilizzare! Non usare se laconfezione è stat aperta o danneggiata! Eliminare il prodotto aperto e non usato!

CONSERVAZIONESi consiglia di conservare il prodotto a temperatura inferiore a 25° C, lontano daumidità e fonti di calore. Non usare il prodotto oltre la data di scadenza!

gemetaboliseerd. Het oplossen begint met een verlies van de treksterkte, ge-volgd door een vermindering van de massa. Implantatie studies bij de rat hebbende volgende resultaten gegeven:

GEKLEURD ONGEKLEURDPost-implantatie Overblijvende Post-implantie Overblijvende

treksterkte treksterkte7 dagen 60% 7 dagen 50%14 dagen 30% 14 dagen 20%De gehele oorspronkelijke treksterkte is 28 De gehele oorspronkelijke treksterkte is 21dagen na implantatie vrijwel verdwenen. dagen na implantatie vrijwel verdwenen.Resorptie is zo goed als volledig na 90 tot 120 dagen.

CONTRA-INDICATIESDit hechtmateriaal (gekleurd en ongekleurd) moet, aangezien het resorbeerbaaris, niet worden gebruikt voor de adaptie van uitgebreide wonden waarbij sprake isvan spanning op het weefsel. MONOCRYL® ongekleurd hechtmateriaal moetniet worden gebruikt voor het sluiten van de buikwand of van bindweefsellagen

WAARSCHUWINGEN / VOORZORGSMAATREGELEN / INTERACTIESDe veiligheid en de doeltreffendheid van MONOCRYL® hechtmateriaal is nietvastgesteld in de volgende gebieden – zenuwweefsel, hart- en vaatweefsel,microchirurgie en oogheelkundige chirurgie. De gebruiker moet vertrouwd zijnmet de methodes en technieken betreffende resorbeerbaar hechtmateriaal al-vorens gebruik te maken van MONOCRYL® hechtingen voor het sluiten van eenwond, aangezien het risico van dehiscentie van de wond kan variëren, afhanke-lijk van de plaats van de wond en van het gebruikte hechtmateriaal.Bij het kiezenvan een hechtdraad moet de chirurg rekening houden met de in vivo eigen-schappen (zie paragraaf WERKING).Dit hechtmateriaal kan ongeschikt zijn voorbejaarde, ondervoede of verzwakte patiënten, of voor patiënten die lijden aanaandoeningen die de wondheling kunnen vertragen. Evenals met andere vreem-de lichamen, kan een langdurig contact van hechtingen met zoutoplossingen,zoals bijvoorbeeld in de urine- of galwegen, leiden tot steenvorming. MONO-CRYL® kan, als oplosbaar materiaal, tijdelijk optreden als lichaamsvreemde stof.Besmette of geïnfecteerde wonden moeten op aanvaardbare wijze chirurgischbehandeld worden. Aangezien het hier gaat om resorbeerbaar hechtmateriaal,moet de chirurg het gebruik van extra, niet-resorbeerbare hechtingen in overwe-ging nemen bij het sluiten van wonden die onder spanning kunnen komen testaan, of waarbij meer ondersteuning nodig is.Hechtingen van de huid die langerdan 7 dagen blijven zitten en plaatselijke irritatie veroorzaken moeten wordenafgeknipt of verwijderd. Subcutane hechtingen moeten zo diep mogelijk wordenaangebracht, om erytheem en induratie die normaliter gepaard gaan met hetresorptieproces, zo gering mogelijk te houden. Onder bepaalde omstandighe-den, met name bij orthopedische ingrepen, kan immobilisatie van het gewrichtmet uitwendige hulpmiddelen worden toegepast, afhankelijk van het oordeel vande chirurg. Bij het gebruik van resorbeerbaar hechtmateriaal in weefsel met eenslechte doorbloeding is voorzichtigheid geboden, aangezien zich afstoting vanhet hechtmateriaal en een vertraagde resorptie kan voordoen. Bij het hanterenvan dit of enig ander hechtmateriaal moet zorgvuldig te werk worden gegaan ombeschadiging te voorkomen. Vermijd pletten en vouwen ten gevolge van hetgebruik van chirurgische instrumenten, zoals pincet of naaldvoerder. De juiste

BESCHRIJVINGMONOCRYL® is een steriele synthetisch resorbeerbaar monofilament hechtma-teriaal, vervaardigd uit een copolymeer van glycolide en Â-caprolactone. De mole-culaire formule van het polymeer is (C2H2O2)m(C6H10O2)n.Poliglecaprone 25 copolymeer heeft geen antigene of pyrogene werking en ver-oorzaakt slechts een geringe weefselreactie tijdens de resorptie.MONOCRYL® hechtmateriaal wordt gekleurd door toevoeging van D&C violet no. 2(kleur index nummer 60725) tijdens het polymerisatieproces. MONOCRYL® hecht-materiaal is ook ongekleurd verkrijgbaar. MONOCRYL® hechtmateriaal is verkrijg-baar in verschillende standaardmaten en -lengten, al of niet voorzien van roestvrijsta-len naalden in diverse soorten en maten. De naalden kunnen blijvend vast zitten ofzijn aangehecht als CONTROL RELEASE, zodat ze van de draad kunnen wordenafgetrokken in plaats van te worden afgeknipt. De volledige details betreffende deproduktreeks staan beschreven in de catalogus.MONOCRYL® voldoet aan alle vereisten van de Europese Farmacopee voor SterileSynthetic Absorbable Monofilament Sutures en aan die van de United States Phar-macopoeia for Absorbable Surgical Sutures met uitzondering van een geringe over-schrijding van de diameter.

INDICATIESMONOCRYL® hechtingen zijn bestemd voor gebruik bij algemene adaptatie vanweke delen en/of als ligaturen, waarbij een resorbeerbaar materiaal is geïndiceerd.

TOEPASSINGHet hechtmateriaal moet worden gekozen en aangebracht afhankelijk van de toe-stand van de patiënt, de chirurgische ervaring, de gebruikte techniek en de groottevan de wond.

WERKINGMONOCRYL® hechtmateriaal veroorzaakt in eerste instantie een minimale ontste-kingsreactie in de weefsels en wordt uiteindelijk vervangen door fibreus bindweefsel.Een geleidelijk verlies van de treksterkte en de uiteindelijke oplossing vanMONOCRYL® hechtingen treedt op door hydrolyse, waarbij het copolymeer wordtafgebroken tot adipinezuur, dat vervolgens door het lichaam wordt opgenomen en

GebrauchsanweisungMONOCRYL®STERIL

Instrucciones de usoMONOCRYL®ESTERILNotice d'utilisationMONOCRYL®STERILE

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MONOCRYL®POLIGLECAPRONA 25

FIO DE SUTURAESTERILIZADO, SINTÉTICO, REABSORVÍVEL

COLORIDO INCOLORDias após a implantação Força Tênsil Dias após a implantação Força Tênsil

Residual Aprox Residual Aprox(% do valor inicial) (% do valor inicial)

7 dias 60 % 7 dias 50%14 dias 30 % 14 dias 20%A força tênsil é praticamente nula ao fim A força tênsil é praticamente nula ao fimde 28 dias após a implantação. de 21 dias após a implantação.

A reabsorção é praticamente total entre os 90 e os 120 dias após a implantação.

CONTRA-INDICAÇÕESUma vez que estes fios de sutura ( com e sem cor ) são reabsorvíveis, nãodevem ser utilizados nos casos em que é necessária uma coaptaçãoprolongada de estruturas sob tensão. O MONOCRYL® INCOLOR não deve serutilizado cm casos de fecho abdominal ou de tecidos da fáscia.

ADVERTÊNCIAS / PRECAUÇÕES / INTERACÇÕESA segurança e a eficácia dos fios de sutura MONOCRYL® ainda não foramdeterminadas nas seguintes áreas: intervenções neurológicas ecardiovasculares, microcirurgia e cirurgia oftálmica. O utilizador deve dominaras técnicas cirúrgicas que envolvem o uso de suturas reabsorvíveis antes deutilizar o MONOCRYL®, pois o risco de deiscência varia consoante o local deaplicação e o tipo de material de sutura utilizado. Ao escolher estes fios desutura, o cirurgião deve ter em atenção as propriedades do produto in vivo (vera secção “Actuação”). Este fio de sutura pode ser contra-indicado no caso depacientes idosos, desnutridos ou debilitados, assim como no caso de pacientesque apresentem uma afecção susceptível de atrasar a cicatrização. Comoacontece com todos os corpos estranhos, o contacto prolongado do fio desutura com as soluções salinas (ao nível das vias urinárias ou biliares, porexemplo) pode conduzir à formação de cálculos. Uma vez que o MONOCRYL®

é um material reabsorvível, pode comportar-se temporariamente como umcorpo estranho. Convém respeitar os procedimentos cirúrgicos habituais para otratamento de feridas contaminadas ou infectadas. Sendo o MONOCRYL® umfio de sutura reabsorvível, o cirurgião deve considerar o uso de suturas nãoreabsorvíveis adicionais no fecho de lesões susceptíveis de serem submetidasa forças de tensão ou de expansão, ou que exijam um reforço suplementar. Assuturas cutâneas que se devem conservar mais de sete dias podem causaruma irritação localizada, e deverão ser cortadas ou retiradas, se for necessário.As suturas subcutâneas devem ser colocadas tão profundamente quantopossível para minimizar o eritema e a fibrose que acompanham geralmente oprocesso de reabsorção. Em determinadas circunstâncias, nomeadamente noquadro das intervenções ortopédicas, o cirurgião pode imobilizar as articulaçõesutilizando um dispositivo de apoio externo. Convém ser-se prudente no caso dautilização de fios de sutura reabsorvíveis ao nível dos tecidos em que a perfusãoé deficiente, pois existe o risco de rejeição da sutura e de atraso da reabsorção.Como acontece com qualquer outro fio de sutura, deve ter-se cuidado para nãodanificar o fio MONOCRYL® durante o seu manuseamento. Em particular, deveter-se cuidado ao utilizar instrumentos cirúrgicos, tais como pinças e porta-agulhas, para evitar danos por dobragem ou esmagamento. Para garantir umacontenção adequada, o fio de sutura deve ser utilizado em conformidade comas técnicas habituais de sutura e de nós cirúrgicos com nós de reforço, de

acordo com a circunstância cirúrgica e a experiência do cirurgião; a utilizaçãodestes nós de reforço é particularmente indicada no caso dos monofilamentos.Deve ter-se cuidado para evitar danos durante o manuseamento das agulhascirúrgicas. O cirurgião deve pegar na agulha na área situada entre um terço(1/3) e um meio (1/2) da distância entre o engaste do fio e a ponta. Se pegar naárea da ponta, pode prejudicar a penetração e causar a quebra da agulha. Sepegar no ponto de engaste, a agulha pode dobrar-se ou partir-se. A tentativa deendireitar as agulhas pode diminuir a resistência global das mesmas, nomea-damente a resistência às dobras e quebra. O utilizador deve ser particularmen-te cuidadoso durante o manuseamento das agulhas cirúrgicas, para evitarpicadas acidentais. Após a utilização, descartar as agulhas nos recipientesreservados a objectos cortantes.

REACÇÕES ADVERSASAs reacções adversas susceptíveis de ocorrer durante a utilização deste produ-to incluem: irritação local transitória ao nível da lesão, reacção inflamatóriatransitória a corpo estranho, aparecimento de eritema e fibrose durante a reab-sorção das suturas subcutâneas. Como acontece com todos os corpos estran-hos, o MONOCRYL® pode agravar uma infecção pré-existente.

ESTERILIZAÇÃOOs fios de sutura MONOCRYL® são esterilizados por irradiação. Não reesterili-zar! Não utilizar se a embalagem estiver aberta ou danificada. Inutilizar o produ-to aberto, não utilizado.

ARMAZENAMENTOCondições de armazenamento: a uma temperatura que não ultrapasse os 25° C e em local seco e fresco. Não utilizar para além do prazo de validade.

DESCRIÇÃO O fio de sutura MONOCRYL® é um monofilamento sintético reabsorvível esteriliza-do, constituído por um copolímero de glicolido e Â-caprolactona. A fórmula molecularempírica deste polímero é (C2H2O2)m (C6H10O2)n. A poliglecaprona 25 não apresentapropriedades antigénicas ou pirogénicas, de modo que a reabsorção éacompanhada apenas por uma reacção mínima dos tecidos. Os fios de suturaMONOCRYL® são tingidos por adição de violeta D&C No 2 ( Numero de Índice deCores 60725 ) durante a polimerização.Também se encontram disponíveis sem cor.Os fios de sutura MONOCRYL® encontram-se disponíveis com vários diâmetros ecomprimentos, sem agulha ou armados com agulhas de aço inoxidável detamanhos e de tipos diferentes. As agulhas podem ser fixas ou amovíveis(chamadas CONTROL RELEASE); neste último caso, não é necessário cortar o fiopara retirar a agulha porque ela pode ser facilmente retirada do fio. O catálogocontém informações pormenorizadas sobre esta gama de produtos. OMONOCRYL® está em conformidade com as especificações da FarmacopeiaEuropeia relativas aos Monofilamentos Sintéticos Reabsorvíveis Esterilizados, ecom as especificações da Farmacopeia dos Estados Unidos relativas às SuturasCirúrgicas Reabsorvíveis, com excepção dos fios com diâmetros ligeiramentemaiores.

INDICAÇÕESOs fios de sutura MONOCRYL® destinam-se a todos os processos de coaptação e/ou laqueação dos tecidos moles, sempre que forem indicados fios reabsorvíveis.

APLICAÇÃOO material de sutura deve ser seleccionado e implantado em função do estado dopaciente, da experiência do cirurgião, da técnica cirúrgica, assim como do tamanhoda lesão.

ACTUAÇÃOOs fios de sutura MONOCRYL® conduzem inicialmente a uma reacção inflamatóriamínima nos tecidos, acabando por ser substituídos por uma proliferação de tecidoconjuntivo fibroso. A perda progressiva da força tênsil e a posterior reabsorção dosfios de sutura MONOCRYL® ocorrem devido a um processo de hidrólise, conduzindoa uma degradação do polímero em ácido adípico que é depois reabsorvido emetabolizado pelo organismo. A reabsorção conduz em primeiro lugar a uma perdade força tênsil, seguida de uma perda de massa. No rato, os estudos de implantaçãorevelaram o seguinte perfil evolutivo:

Bruksan visning S


STERIL, SYNTETISK, RESORBERBAR

SUTUR

FÄRGAD OFÄRGADEfter Ungefärlig återstående Efter Ungefärlig återståendeimplantation hållfasthet implantation hållfasthet

7 dagar 60 % 7 dagar 50%14 dagar 30 % 14 dagar 20%Hela den ursprungliga draghållfastheten har Hela den ursprungliga draghållfastheten hari allt väsentligt gått förlorad 28 dagar efter i allt väsentligt gått förlorad 21 dagar efterimplantationen. implantationen.

Massan är i huvudsak fullständigt resorberad efter 90-120 dagar.

KONTRAINDIKATIONEREftersom dessa suturer (färgade och ofärgade) är resorberbara skall de inte använ-das för sårförslutning där sårkanterna under lång tid är utsatta för påfrestning.Ofärgad MONOCRYL® får ej användas för bukväggsförslutning eller för-slutning avfascia.

VARNINGAR / FÖRSIKTIGHETSÅTGÄRDER / INTERAKTIONMONOCRYL® suturens säkerhet och effektivitet har inte fastställts inom följandeområden: neurologisk vävnad, hjärt-kärlvävnad, mikro- och ögonkirurgi.Användare bör vara väl förfarna i kirurgiska procedurer och tekniker för resorberba-ra suturer innan de använder MONOCRYL® för sårförslutning, eftersom risken föratt såret rupturerar kan variera beroende på var såret är beläget och vilketsuturmaterial som används. Kirurger bör beakta in vivo-prestanda (se avsnittetPRESTANDA) när de väljer sutur. Denna sutur kan vara olämplig för äldre, under-närda eller försvagade patienter, eller för patienter med besvär som kan försenasårläkningen.Som alla andra främmande material kan suturmaterial vid längre tids kontakt medsalthaltiga lösningar (som i urinvägar och gallgångar) leda till stenbildning. I egenskapav resorberbar sutur kan MONOCRYL® tillfälligt uppträda som ett främmandematerial.Vedertagen kirurgisk praxis bör iakttas vid hantering av kontaminerade eller infek-terade sår.Eftersom detta är ett resorberbart material skall kirurgen överväga användningenav kompletterande, icke resorberbara suturer på ställen som är särskilt utsatta förutvidgning, sträckning eller kan kräva ytterligare stöd.Hudsuturer som måste vara kvar längre än 7 dagar kan förorsaka lokal irritation ochbör klippas av eller avlägsnas. Subkutansuturer skall placeras så djupt som möjligtför att minimera den hudrodnad och förhårdnad som vanligen förknippas medresorptionsprocessen.Under vissa förhållanden, i synnerhet vid ortopediska ingrepp, kan kirurgen övervä-ga immobilisering av leder med yttre stöd.Försiktighet bör iakttas vid användning av resorberbara suturer i vävnader meddålig blodtillförsel, eftersom bortstötning av suturen och försenad resorption kanuppträda.Vid hanteringen av detta eller varje annat suturmaterial bör försiktighet iakttas för attundvika att suturen skadas. Undvik att vika eller gripa suturen med kirurgiskainstrument såsom tänger eller nålförare.Fullgod knutsäkerhet kräver kirurgisk standardteknik med parallella slag (råbands-knop) med ytterligare omtag alltefter de kirurgiska omständigheterna och kirurgenserfarenhet. Extra omtag kan vara lämpliga vid användande av en monofil sutur.

Försiktighet bör iakttas för att undvika skada vid hantering av kirurgiska nålar. Fattanålen inom ett område 1/3 - 1/2 av avståndet från bakre änden av nålen tillnålspetsen. Att fatta nålen nära spetsen kan försämra penetrationen och orsakabrott på nålen. Att fatta nålen i bakre änden vid infästningen kan leda till att nålen böjseller bryts. Att böja nålen och ändra dess form kan leda till att den förlorar i styrka ochblir mindre motståndskraftig mot brott och att böjas. Användare bör vara försiktiganär de hanterar kirurgiska nålar för att undvika oavsiktlig skada orsakad av nålstick.Kasta begagnade nålar i därför avsedda behållare.

SIDOEFFEKTERMöjliga sidoeffekter förknippade med denna produkt är övergående lokal irritation isårområdet, övergående inflammatorisk reaktion mot främmande material,hudrodnad och förhårdnad under resorptionsprocessen vid subkutansutur. I likhetmed alla främmande material kan MONOCRYL® förstärka en befintlig infektion.

STERILITETMONOCRYL® suturer steriliseras med etylenoxidgas. Resterilisera ej suturen.Använd den inte om förpackningen har öppnats eller skadats. Kasta bort öppnadeoanvända suturer.

FÖRVARINGRekommenderade lagringsförhållanden är under 25o C samt att suturerna ej fårutsättas för fukt och direkt värme eller användas efter sista förbrukningsdatum.

BESKRIVNINGMONOCRYL® är en steril, syntetisk resorberbar monofil sutur framställd av ett sam-polymerisat av glykolid och Â-kaprolakton. Den empiriska molekylära formeln förpolymeren är (C2H2O2)m (C6H10O2)n.Poliglecaprone 25 copolymer har visat sig vara icke-antigent, icke-pyrogent och fram-kallar endast obetydlig vävnadsreaktion under resorptionsprocessen.MONOCRYL® färgas genom att D&C violett nr 2 (färg index nr 60725) tillsätts underpolymeriseringen. Suturen finns även ofärgad. MONOCRYL® finns i en rad dimen-sioner och längder utan nål eller armerad på nålar av rostfritt stål av varierande typoch storlek. Nålen kan armeras på suturen permanent eller som CONTROL RE-LEASE®, som gör att nålen kan ryckas av istället för att klippas av. Fullständig infor-mation om produktsortimentet återfinns i katalogen.MONOCRYL® uppfyller alla av den europeiska farmakopéns ställda krav för sterilasyntetiska resorberbara monofila suturer samt kraven i US-farmakopén för resorber-bara kirurgiska suturer förutom en lätt överdimensionering.

INDIKATIONERMONOCRYL® suturer är avsedda att användas för approximering av mjukdelsväv-nad och/eller ligering där ett resorberbart material kan användas.

TILLÄMPNINGSuturer bör väljas och användas med hänsyn till patientens tillstånd, kirurgens erfa-renhet, kirurgisk teknik och sårets karaktär.

PRESTANDAMONOCRYL® suturen orsakar minimal initial inflammatorisk reaktion i vävnader ochersätts så småningom av fibrös bindväv. MONOCRYL® suturernas successivt minsk-ade draghållfasthet och slutliga resorption sker genom hydrolys, där polymeren brytsner till fettsyra, som därefter resorberas och metaboliseras i kroppen. Resorptionenbörjar som minskad draghållfasthet följd av massaförlust. Implantationsstudier påråttor visar följande profil:

uitvoering van een hechting vereist de chirurgische standaardmethodes van ge-schikte knooptechnieken met extra knopen aangepast aan de chirurgische om-standigheden en de ervaring van de chirurg. Het gebruik van extra knopen kanmet name geschikt zijn voor het knopen van een monofilament hechtmateriaal.Bij het hanteren van chirurgische naalden is voorzichtigheid geboden om be-schadiging te voorkomen. Grijp de naald op een-derde (1/3) tot de helft (1/2) vande afstand van de achterzijde tot de punt. Het vastpakken dichtbij de punt zou ertoe kunnen leiden dat de naald minder goed doordringt en breekt. Het vastpak-ken bij de achterzijde kan er toe leiden dat de naald buigt of breekt. Het bijbuigenvan naalden kan de sterkte ervan aantasten, zodat ze gemakkelijker buigen enbreken. De gebruiker moet voorzichtig zijn bij het hanteren van chirurgische naal-den om te vermijden dat hij zich per ongeluk prikt. Gooi gebruikte naalden weg in“Sharps” bakken.

BIJWERKINGENBijwerkingen ten gevolge van het gebruik van dit materiaal zijn o.a. voorbijgaan-de plaatselijke irritatie bij de wond, een voorbijgaande ontstekingsreactie op delichaamsvreemde stof, erytheem en induratie tijdens resorptie van subcutanehechtingen. Evenals alle lichaamsvreemde stoffen kan MONOCRYL® een be-staande infectie verergeren.

STERILITEITMONOCRYL® hechtmateriaal is gesteriliseerd met ethyleenoxide gas. Nietopnieuw steriliseren. Niet gebruiken indien de verpakking is geopend of bescha-digd. Geopend, ongebruikt hechtmateriaal wegwerpen.

OPSLAGAanbevolen bewaaromstandigheden: bij een temperatuur lager dan 25° C, in eendroge en koele omgeving. Niet te gebruiken na de vervaldatum.

SYMBOLEN OP DE ETIKETTEN

= Bestemd voor eenmalig gebruik

= Uiterste gebruiksdatum (jaar/maand)

= Steriel tenzij verpakking is beschadigd of geopendSterilisatiemethode – Ethyleenoxide

0086 = CE-markering en identificatienummer Aangemelde instantie. Produkt conform de essentiële eisen van de Richtlijn medische hulpmiddelen (93/42/EEG)

= Lotnummer (Partij)

= Zie de gebruiksaanwijzing

LOT

P

SÍMBOLOS UTILIZADOS NOS RÓTULOS

= Não reutilizar

= Validade: Ano – Mês

= O produto está esterilizado, excepto se aembalagem estiver aberta ou danificada.Método de Esterilização: Óxido de Etileno

0086 = Marca CE e número de identificação do organismo notificado. O produto obedece aos principaisrequisitos da Directiva sobre Dispositivos Médicos 93/42/CEE.

= Número do lote

= Ver instruções de uso

LOT

SYMBOLER ANVÄNDA VID MÄRKNING

= Engångsbruk

= Användes senast – år och månad

= Sterilt, om inte förpackningen är öppnad eller skadad.Steriliseringsmetod – Etylenoxid

0086 = CE-märke + identifieringsnummer för AnmältOrgan. Produkten uppfyller de väsentligakraven i Medical Device Directive 93/42/EEC

= Satsnummer

= Se bruksanvisningen

LOT

LOT

Authorized Representatives/Distributors Autoriserede repræsentanter/DistributørerErkende vertegenwoordigers/DistributeursValtuutetut edustajat/TukkumyyjätReprésentants autorisés / DistributeursAutorisierte Vertreter/VertriebRappresentanti autorizzati/DistributoriRepresentantes autorizados/DistribuidoresRepresentantes autorizados/DistribuidoresAuktoriserade representanter/Distributörer∂ÍÔ˘ÛÈÔ‰ÔÙËÌ¤ÓÔÈ ·ÓÙÈÚfiÛˆÔÈ/¢È·ÓÔÌÂ›˜

Distributor • Distributeur • Distribuidor Distributore • Distributeur • Distribuidor Tukkumyyjä • Distribuidor • VertriebDistributör • ¢È·ÓÔÌ¤·˜

ETHICON FranceETHICON Limitedune division ETHNOR S.A.PO Box 408TSA 81002Bankhead Avenue1, rue Camille DesmoulinsEdinburgh EH11 4HE92787 Issy Les Moulineaux Cedex 9United KingdomFranceTel: 0131-453 5555Tél : 33+ 01 55 00 22 00

ETHICON GmbH & Co. KGETHICON S.p.A.Robert-Koch-Strasse 1Via del Mare 56D-22851 Norderstedt00040 PomeziaDeutschlandRomaTel: 040/52 97-01Italia

Tel: 06-911 944 32

CH: Johnson & Johnson AGRotzenbuehlstrasse 55

8957 Spreitenbach

acompany


ERKLÄRUNG DER SYMBOLE AUF DER VERPACKUNG

= Nicht wiederverwenden!

= Verwendbar bis Jahr & Monat

= Steril, solange die Verpackung ungeöffnet und unbeschädigt ist. Sterilisationsmethode – Ethylenoxid

0086 = CE-Zeichen und Identifikationsnummer der Benannten Stelle. Das Produkt entspricht den grundlegenden Anforderungen der Richtlinie des Rates über Medizinprodukte 93/42/EWG

= Chargenbezeichnung

= Bitte Gebrauchsinformation beachten!

SYMBOLES UTILISES SUR L’ETIQUETTE

= Usage unique

= A utiliser avant: année et mois

= Produit stérile si l'emballage n'a pas été ouvertou endommagé.Méthode de stérilisation – oxyde d’éthylène

0086 = Marquage CE + no identification de l'organisme notifié.Produit conforme aux exigences essentielles de la Directive Européenne 93/42/CEE sur les dispositifs médicaux

= Numéro du lot

= Lire attentivement la notice d’utilisation

Notice d'utilisation F Käyttöoh jeet FIN

MONOCRYL®POLIGLEKAPR ONI 25

STERIILI, SYNTEETTINEN, RESORBOITUVA

OMMELAINE

Bru gsanvisnin g DK Instrucciones de uso E


STERIL, SYNTETISK, RESORBERBAR

SUTUR

MONOCRYL®DE POLIGLECAPRONA 25

SUTURA ESTERIL, SINTETICA, ABSORBIBLE

FARVET UFARVETEfter implantation Ca. resterende Efter implantation Ca. resterende

trækstyrke trækstyrke7 dage 60% 7 dage 50%14 dage 30% 14 dage 20%Hele den oprindelige trækstyrke er stort Hele den oprindelige trækstyrke er stortset forsvundet 28 dage efter implantationen. set forsvundet 21 dage efter implantationen.

Resorptionen er stort set afsluttet mellem 90 og 120 dage.

KONTRAINDIKATIONERDa suturerne (både farvede og ufarvede) resorberes, bør de ikke anvendes, hvor derkræves længerevarende vævsapproksimering under belastning.UFARVET MONOCRYL® må ikke anvendes til lukning af abdomen eller til lukning affascie.

ADVARSLER / FORHOLDSREGLER / INTERAKTIONERMONOCRYL® suturernes sikkerhed og effektivitet er ikke fastslået på følgende om-råder: nervevæv, kardiovaskulært væv, mikrokirurgi og øjenkirurgi.Brugere må være bekendt med kirurgiske procedurer og metoder, der omfatter re-sorberbare suturer, før de benytter MONOCRYL® suturer til sårlukning, da risikoenfor sårruptur kan variere efter anvendelsessted og det anvendte suturmateriale. Ki-rurgen bør tage højde for in vivo egenskaberne (se afsnittet om VIRKNING), når dervælges sutur. Suturen kan være uegnet hos ældre, underernærede eller debile pa-tienter, eller hos patienter med lidelser, der kan medføre forsinket sårheling.Som ethvert fremmedlegeme kan suturer ved længerevarende kontakt med saltop-løsninger, der svarer til forholdene i urin- eller galdevejene, resultere i stendannelse.MONOCRYL® kan som resorberbar sutur forbigående virke som fremmedlegeme.Kontaminerede eller inficerede sår skal behandles efter almindelig kirurgisk praksis.Som ved alle resorberbare suturmaterialer bør kirurgen overveje at anvende sup-plerende ikke-resorberbare suturer ved lukning af sår, der kan blive udsat for udvi-delse, stræk eller udspiling, eller som behøver ekstra støtte.Hudsuturer, der skal ligge længere end 7 dage, kan forårsage lokalirritation og børforkortes eller fjernes. Subepidermale suturer bør sættes så dybt som muligt for atformindske erytemet og indurationen, der sædvanligvis er forbundet med resorp-tionsprocessen.I nogle tilfælde, specielt ved ortopædkirurgiske procedurer, kan der foretages immo-bilisering af led med bandage efter kirurgens skøn.Man bør være forsigtig med at anvende resorberbare suturer i væv med ringe blod-gennemstrømning, da der kan ske suturudstødelse og forsinket resorption.Der skal udvises forsigtighed for at undgå at beskadige dette såvel som andre sutur-materialer under håndteringen. Undgå at knuse eller knække suturen ved anvendel-se af kirurgiske instrumenter som f.eks. pincet eller nåleholder.Tilstrækkelig sikker suturering forudsætter almindelige kirurgiske knuder med ekstraslag, afhængigt af de operative forhold og kirurgens erfaring. Anvendelsen af knudermed ekstra slag kan være særlig nødvendigt ved bindingen af monofile suturer.Undgå omhyggeligt at beskadige suturnålene. Grib nålen på et sted mellem entredjedel (1/3) og halvdelen (1/2) af afstanden fra trådfæstet til spidsen. Hvis nålengribes ved spidsen, kan det forringe indstikkets penetration og medføre, at nålenknækker. Hvis nålen gribes i den anden ende eller på trådfæstet, kan det medføre, atnålen bøjer eller knækker. Hvis bøjede nåle rettes op, kan de miste styrken og få

større tilbøjelighed til at knække. Brugeren bør udvise forsigtighed under an-vendelsen af operationsnåle for at undgå utilsigtede nålestik. Smid brugte nålei de dertil beregnede beholdere.

BIVIRKNINGERBivirkninger forbundet med anvendelsen af dette materiale omfatter: forbi-gående lokalirritation på sårstedet, forbigående inflammatorisk fremmed-legemereaktion samt erytem og induration under resorptionen af subepiderma-le suturer. Som alle andre fremmedlegemer kan MONOCRYL® forværre eneksisterende infektion.

STERILITETMONOCRYL® suturer steriliseres med ethylenoxidgas. Resteriliser ikke! An-vendes ikke, hvis emballagen er åbnet eller beskadiget! Åbnede ubrugte sutu-rer kasseres.

OPBEVARINGAnbefalet opbevaring: Tørt og under 25°C. Undgå direkte varmepåvirkning. Måikke anvendes, efter at holdbarhedsdatoen er overskredet.

BESKRIVELSEMONOCRYL® er en steril syntetisk resorberbar monofil sutur, der er fremstillet af encopolymer af glykolid og Â-kaprolakton. Polymerens empiriske molekyleformel er(C2H2O2)m (C6H10O2)n.Poliglecaprone 25 copolymer har vist sig at være non-antigen og non-pyrogen, ogden forårsager kun let vævsreaktion under resorptionen.MONOCRYL® suturer er farvet med D&C violet nr. 2 (farveindeks nr. 60725) underpolymerisation. Suturerne fås også ufarvede. MONOCRYL® fås i en række forskelli-ge kalibre og længder med eller uden nåle (rustfrit stål) i forskellige typer og størrel-ser. Nålene kan være fastgjort permanent eller som CR-nåle (control release), dermuliggør, at nålene kan trækkes af i stedet for at blive klippet af. Der er udførligebeskrivelser om produktsortimentet i kataloget.MONOCRYL® opfylder kravene i European Pharmacopoeia for Sterile SyntheticAbsorbable Monofilament Sutures og kravene i United States Pharmacopoeia forAbsorbable Surgical Sutures, bortset fra en mindre overstørrelse af diameteren.

INDIKATIONERMONOCRYL® suturer er beregnet til anvendelse i almindeligt bindevæv og/eller tilligatur, hvor et resorberbart materiale er indiceret.

ANVENDELSESuturerne vælges og implanteres afhængigt af patientens tilstand, kirurgisk erfa-ring, kirurgisk teknik og sårets størrelse.

VIRKNINGMONOCRYL® suturer fremkalder minimal initial inflammatorisk vævsreaktion, ogsuturen ender med at blive erstattet med indvækst af fibrøst bindevæv. Det gradvisetab af trækstyrke og den endelige resorption af MONOCRYL® suturer foregår vedhydrolyse, idet polymeren nedbrydes til adipinsyre, som derefter resorberes og me-taboliseres i legemet. Resorptionen begynder som tab af trækstyrke fulgt af masse-tab. Implantationsundersøgelser hos rotter viser følgende profil:

SYMBOLER ANVENDT VED MÆRKNING

= Engangsbrug

= Anvendes senest år og måned

= Steril medmindre pakningen er åbnet ellerbeskadiget.Steriliseringsmetode – Ethylenoxid

0086 = CE-mærkning + identifikationsnummer for BemyndigetOrgan. Produktet opfylder de væsentlige krav iMedical Device Directive 93/42/EEC

= Batchkode

= Se brugsanvisningen

LOT

DESCRIPCIONEl MONOCRYL® es una sutura estéril sintética absorbible monofilamento hechadel copolímero de glicólida y Â-caprolactona. La fórmula molecular empírica delpolímero es (C2H2O2)m (C6H10O2)n.Se ha demostrado que el copolímero Poliglecaprona 25 es no-antigénico, no-pirogénico y tan sólo produce una ligera reacción durante la absorción.Las suturas MONOCRYL® son teñidas añadiendo D&C violeta nº 2 (Color Indexnº 60725) durante la polimerización. Estas suturas están también disponiblesincoloras. Está disponible en una amplia gama de calibres y longitudes, con osin aguja de acero inoxidable de diversos tipos y tamaños. Las agujas puedenser permanentes o CONTROL RELEASE, que permite eliminarlas de un tirónen vez de cortarlas. El catálogo contiene todos los detalles sobre la gama com-pleta de productos.La sutura MONOCRYL® cumple con todos los requisitos de la FarmacopeaEuropea para las Suturas Monofilamento Absorbibles, y los requisitos de laFarmacopea de los Estados Unidos para Suturas Quirúrgicas Absorbibles, aexcepción de una ligera diferencia en el calibre.

INDICACIONESLas suturas MONOCRYL® están indicadas para la aproximación general de lostejidos blandos y/o ligaduras en las que estén indicadas las suturas absorbibles.

APLICACIONLas suturas deben seleccionarse e implantarse dependiendo del estado delpaciente, de la experiencia quirúrgica, de la técnica quirúrgica y del tamaño dela herida.

COMPORTAMIENTOLa sutura MONOCRYL® produce una mínima reacción inicial inflamatoria en lostejidos, y luego es reemplazada por un desarrollo de tejido fibroso conectivo. Lapérdida progresiva de resistencia a la tensión y la absorción eventual de lassuturas de MONOCRYL® se produce gracias a la hidrólisis, que hace que elpolímero se transforme en ácido adípico que posteriormente es absorbido ymetabolizado por el organismo. La absorción empieza como pérdida de resis-tencia a la tensión, seguida por pérdida de masa. Los estudios de implantaciónen la rata muestran el siguiente perfil:

TEÑIDO INCOLOROTiempo tras Resistencia remanente Tiempo tras Resistencia remanentela implantación aproximada la implantación aproximada

(% de la original) (% de la original)7 días 60 % 7 días 50 %14 días 30 % 14 días 20 %Toda la resistencia inicial a la tensión Toda la resistencia inicial a la tensiónse pierde esencialmente en los 28 días se pierde esencialmente a los 21 díasque siguen a la implantación. que siguen a la implantación.

La absorción queda esencialmente terminada entre los días 90 y 120.

CONTRAINDICACIONESEstas suturas (teñidas e incoloras), siendo absorbibles, no están indicadas paraaquellos usos en los que se requiera una aproximación prolongada de tejidos so-metidos a tensión.El MONOCRYL® incoloro no debe ser usado para cierre abdominal o cierre defascia.

ADVERTENCIAS / PRECAUCIONES / INTERACCIONESNo ha sido determinada la seguridad ni la efectividad de las suturas de MONO-CRYL® en el caso de tejido nervioso, tejido cardiovascular, microcirugía y cirugíaoftálmica. Antes de emplear la sutura MONOCRYL® para el cierre de heridas, elusuario debe conocer a fondo los procedimientos y técnicas quirúrgicas aplicables alas suturas absorbibles, ya que el riesgo de dehiscencia de la herida varía depen-diendo del sitio de aplicación y del material de sutura empleado. Los cirujanos de-ben tener en cuenta el comportamiento in-vivo (ver apartado COMPORTAMIEN-TO) cuando deban seleccionar una sutura. Esta sutura puede ser inadecuada enpacientes de edad, o mal nutridos o que padezcan enfermedades que prolonguenel proceso de cicatrización de las heridas. Como sucede con cualquier cuerpo ex-traño, el contacto prolongado de la sutura con soluciones salinas tales como las quese encuentran en el tracto urinario o biliar pueden dar como resultado la formaciónde cálculos. Por el hecho de ser absorbible, la sutura MONOCRYL® puede actuartransitoriamente como cuerpo extraño. Debe seguirse la práctica quirúrgica acepta-da cuando se trate de heridas contaminadas o infectadas. Puesto que se trata deun material de sutura absorbible, el cirujano deberá juzgar la conveniencia de usarsuturas adicionales no absorbibles en los lugares sometidos a expansión, estira-miento o distensión, o que necesiten soporte adicional. Las suturas de piel que semantengan en su lugar más de siete días pueden causar una irritación localizada ydeberán ser cortadas o retiradas. Las suturas subcuticulares deben implantarse tanprofundamente como sea posible con el fin de minimizar el eritema y la induraciónque normalmente están asociados con el proceso de absorción. En determinadascircunstancias, en especial los procedimientos ortopédicos, la inmovilización de ar-ticulaciones mediante soportes externos puede emplearse a discreción del cirujano.Debe evaluarse el uso de las suturas absorbibles en el caso de tejidos de escasairrigación sanguínea, ya que puede producirse la extrusión de la sutura y el retrasode la absorción. Debe evitarse estropear este o cualquier otro material de suturadurante la manipulación. Evitar en especial los pliegues y aplastamientos debidos ala aplicación de instrumentos quirúrgicos tales como pinzas o portagujas. La ade-cuada seguridad de los nudos requiere la aplicación de la técnica quirúrgica están-dar de nudos planos y cuadrados, con lazadas adicionales de acuerdo con lo queindiquen las circunstancias quirúrgicas y la experiencia del cirujano. El uso de laza-

das adicionales puede ser especialmente adecuado al anudar cualquier suturamonofilamento. Debe tenerse cuidado de no estropear las agujas quirúrgicasdurante su manipulación. Asir la aguja entre un tercio (1/3) y la mitad (1/2) de ladistancia entre la cabeza y la punta. Asirla cerca de la punta puede perjudicar lapenetración y producir la rotura de la aguja. Asirla por el extremo de la cabezapuede producir una torsión o rotura. El enderezar las agujas puede disminuir suresistencia a las torsiones y roturas. Los usuarios deben manipular con precau-ción las agujas quirúrgicas con el fin de evitar heridas causadas por inadverten-cia. Desechar las agujas usadas en contenedores especiales.

REACCIONES ADVERSASLas reacciones adversas asociadas con el uso de este dispositivo incluyen irrita-ción local transitoria en el sitio de la lesión, respuesta inflamatoria transitoria anteel cuerpo extraño así como eritema e induración durante la absorción en lostejidos subcuticulares. Como sucede con todos los cuerpos extraños, la suturaMONOCRYL® puede aumentar una infección existente.

ESTERILIDADLas suturas MONOCRYL® están esterilizadas con óxido de etileno. No reesteri-lizar. No usar si el envase está abierto o dañado. Desechar las suturas abiertasno utilizadas.

ALMACENAMIENTOCondiciones recomendadas de almacenamiento: menos de 25° C, alejada de lahumedad y del calor directo. No usar después de la fecha de caducidad.

SIMBOLOS EMPLEADOS EN LAS ETIQ UETAS

= Un solo uso

= Usar hasta el año y mes

= Estéril mientras el envase no sea abierto o dañado.Método de esterilización – Oxido de etileno

0086 = Marca CE + número de identificación del organismo notificado.Este producto se ajusta a los requisitos esenciales de ladirectiva de productos sanitarios 93/42/EEC

= Número de lote

= Ver instrucciones de uso

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VIOLET INCOLOREJours après l’implantation Résistance Jours après l’implantation Résistance

résiduelle résiduelle (environ) (environ)

7 jours 60% 7 jours 50%14 jours 30% 14 jours 20%La résistance à la traction est pratiquement La résistance à la traction est pratiquement nulle au bout de 28 jours d’implantation. nulle au bout de 21 jours d’implantation.

La résorption est pratiquement totale entre le 90ème et le 120ème jour.

CONTRE-INDICATIONSCes fils de suture (violet et incolore) étant résorbables, ils ne doivent pas êtreutilisés lorsqu’un rapprochement prolongé de tissus sous tension est nécessaire.Le MONOCRYL® INCOLORE ne doit pas être utilisé pour la fermeture abdomi-nale ou pour fermer des tissus aponévrotiques.

MISES EN GARDE / PRECAUTIONS D’EMPLOI / INTERACTIONSLa sécurité d’emploi et l’efficacité des fils de suture MONOCRYL® n’ont pas étéétablies dans les domaines suivants : tissus nerveux ou cardio-vasculaires, micro-chirurgie et chirurgie ophtalmologique. L’utilisateur doit connaître les techniqueschirurgicales relatives à l’utilisation de sutures résorbables avant d’utiliser MO-NOCRYL® , ainsi que le risque de déhiscence de la plaie qui dépend du siteopératoire et du composant de la suture. Le choix des fils de suture est fonctiondes propriétés du dispositif in vivo (voir la rubrique MODE D’ACTION). Ces fils desuture sont contre-indiqués chez les malades âgés, dénutris ou débilités ainsique chez ceux présentant une affection entraînant un retard de cicatrisation. Com-me avec tout corps étranger, le contact prolongé de la suture avec les milieuxsalins tels que les urines ou la bile peut entraîner la formation de lithiases. Dans lamesure où le fil de suture MONOCRYL® est un matériau résorbable, il peut secomporter transitoirement comme un corps étranger. Il convient de respecter lesprocédures habituelles nécessaires au contrôle de la contamination ou del’infection de la plaie. Le fil de suture MONOCRYL® étant résorbable, le chirurgienpeut envisager d’utiliser en complément des sutures non résorbables s’il s’agit delésions susceptibles de se trouver en tension ou nécessitant un renfort. Les su-tures cutanées qui doivent rester en place plus de sept jours peuvent entraînerune irritation locale et seront retirées si nécessaire. Les sutures intracutanéesseront posées aussi profondément que possible afin de minimiser l’érythème etl’induration qui accompagnent généralement le processus de résorption. Danscertaines circonstances, notamment les procédés de chirurgie orthopédique, uneimmobilisation par un procédé de contention externe peut être utilisée à la discré-tion du chirurgien. Il convient d’être prudent en cas d’utilisation de fils de suturerésorbables au niveau de tissus mal irrigués car il existe alors un risque de rejetde la suture et de retard de résorption. Une attention particulière doit être portéeà la manipulation du fil. Ne pas pincer ou écraser le fil en le prenant dans unepince ou un porte aiguille. La garantie d’un noeud fiable est basée sur l’utilisationde noeud plat et de double-noeud ainsi que de noeuds supplémentaires si lechirurgien l’estime nécessaire. Il est particulièrement recommandé de faire desnoeuds supplémentaires avec les monofilaments. Des précautions sont à res-pecter pour ne pas endommager les aiguilles. Saisir l’aiguille dans l’espace sesituant du tiers à la moitié du corps, coté fil. Ne pas pincer la pointe ce qui pourrait

modifier les caractéristiques de pénétration de l’aiguille et la casser. Ne pas saisirl’aiguille par la zone de sertissage ce qui entraînerait un risque de torsion ou derupture. Ne pas modifier la forme de l’aiguille afin d’éviter de l’endommager ou de lacasser. L’utilisateur doit prendre les précautions liées à la manipulation d’aiguille afind’éviter tout risque de blessure. Eliminer les aiguilles usagées dans un conteneuradapté.

REACTIONS INDESIRABLESLes réactions indésirables susceptibles d’apparaître lors de l’utilisation de ce disposi-tif incluent une irritation locale transitoire au niveau de la plaie, une réaction inflam-matoire à corps étranger transitoire, l’apparition d’un érythème et d’une induration aucours de la résorption des sutures sous-cutanées. Comme tout corps étranger,MONOCRYL® peut majorer une infection préexistante.

STERILISATIONLes fils de suture MONOCRYL® sont stérilisés à l’oxyde d’éthylène. Ne pas restérili-ser ! Vérifier l’intégrité du protecteur individuel de stérilité avant usage. Ne pas utiliserle produit si l’emballage a été endommagé ou ouvert.

CONSERVATIONConditions de conservation recommandées : conserver à une température ne dépas-sant pas 25° C, à l’abri de l’humidité et d’une exposition directe à la chaleur. Ne pasutiliser après la date de péremption.

MONOCRYL®POLYGLECAPRONE 25

FIL DE SUTURE STERILE, SYNTHETIQUE, RESORBABLE

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DESCRIPTIONLe fil de suture MONOCRYL® est un fil de suture synthétique résorbable stérile,présenté en monofil et constitué d’un copolymère de glycolate et d’Â-caprolacto-ne. La formule brute de ce polymère est (C2H2O2)m (C6H10O2)n. Il a été montré quele polyglecaprone 25 ne présente pas de propriétés antigénique ou pyrogène desorte que la résorption s’accompagne d’une réaction tissulaire minime. Les fils desuture MONOCRYL® violet sont colorés par l’addition de D&C violet no. 2 (indexde couleur numéro 60725) au cours de la polymérisation. Ils sont également dis-ponibles sous forme incolore. Les fils de sutures MONOCRYL® sont disponiblesdans une large gamme de décimales et de longueurs, sertis sur aiguilles en acierinoxydable de tailles et de profils différents ou non sertis. Les aiguilles sont soitfixes, soit auto-détachables (CONTROL RELEASE): dans ce dernier cas il n’estpas nécessaire de couper le fil pour enlever l’aiguille car elle peut être détachéede celui-ci. Consulter le catalogue pour plus de renseignements. Le MONOCRYL®

est conforme à la monographie de la Pharmacopée Européenne relative aux “FilsRésorbables Synthétiques Monofilaments Stériles” et à celle de la PharmacopéeAméricaine relative aux sutures chirurgicales résorbables, à l’exception de cer-tains fils de diamètres légèrement plus grands.

INDICATIONSLes fils de suture MONOCRYL® sont destinés à toutes les procédures de coapta-tion et/ou de ligature des tissus mous lorsqu’un fil résorbable peut être utilisé.

MODE D’EMPLOILe choix et l’implantation de la suture dépendent du patient, du chirurgien, de latechnique chirurgicale et de la taille de la lésion.

MODE D’ACTIONLes fils de suture MONOCRYL® entraînent initialement une réaction inflamma-toire minime et sont remplacés ultérieurement par une prolifération de tissu con-jonctif fibreux. La diminution progressive de la résistance à la traction ainsi que larésorption ultérieure des fils de suture MONOCRYL® sont dues à un processusd’hydrolyse entraînant une dégradation du polymère en acide adipique lequel estrésorbé et métabolisé par l’organisme. La résorption entraîne tout d’abord unediminution de la résistance à la traction suivie d’une disparition de la matière.Chez le rat, les études d’implantation ont permis de dégager le profil évolutif sui-vant :

KUVAUSMONOCRYL® on steriili synteettinen resorboituva yksisäikeinen ommelaine, jokaon valmistettu glykolidin ja Â-kaprolaktonin kopolymeeristä. Polymeerin empiirinenkaava on (C2H2O2)m (C6H10O2)n.Poliglekaproni 25 kopolymeeri on todettu ei-antigeeniseksi ja pyrogeenittomaksi ai-neeksi, joka resorboituessaan aiheuttaa vain lievän kudosreaktion.MONOCRYL®-ommelaineet on värjätty D&C-violetilla numero 2 (Colour Index No.60725) polymerisaation aikana. Ommelaineita on saatavana myös värjäämättömä-nä. MONOCRYL®-ommelaineita on saatavana erivahvuisina ja -pituisina kiinnitet-tyinä erityyppisiin ja -kokoisiin teräsneuloihin. Neulat voivat olla kiinnitettyinä pysyväs-ti tai VAPAUTUSMEKANISMILLA, joka mahdollistaa neulan irrottamisen langan katkaisemisen sijasta. Katso täydelliset tiedot tuoteluettelosta.MONOCRYL® täyttää kaikki Euroopan farmakopean “Sterile Synthetic AbsorbableMonofilament Sutures” -monografian ja Yhdysvaltain farmakopean “AbsorbableSurgical Sutures” -monografian vaatimukset lukuun ottamatta langan läpimitan lie-vää ylittymistä.

INDIKAATIOTMONOCRYL®-ommelaineet on tarkoitettu yleiseen pehmytkudosten kiinnittämi-seen ja/tai ompeluun tapauksissa, joissa resorboituva materiaali on indisoitu.

KÄYTTÖOmmelaineen valintaan ja käyttöön vaikuttavat potilaan tila, kirurgin kokemus, leik-kaustekniikka ja haavan koko.

OMINAISUUDETMONOCRYL®-ommelaine aiheuttaa aluksi lievän inflammatorisen kudosreaktion,mutta korvautuu vähitellen tiheällä sidekudoksella. Vetolujuus häviää vähitellen jaMONOCRYL®-ompeleet resorboituvat hydrolysoitumalla, jolloin polymeeri hajoaaadipiinihapoksi, joka imeytyy ja metaboloituu. Resorptio alkaa vetolujuuden heikke-nemisenä, jota seuraa massan menetys. Rotilla tehdyissä implantaatiotutkimuksis-sa on saatu seuraavanlainen profiili::

VÄRJÄTTY VÄRJÄÄMÄTÖNImplantaation Alkuperäisestä veto- Implantaation Alkuperäisestä veto-jälkeen lujuudesta jäljellä jälkeen lujuudesta jäljellä7 päivää 60 % 7 päivää 50 %14 päivää 30 % 14 päivää 20 %Koko alkuperäinen vetolujuus häviää Koko alkuperäinen vetolujuus häviää

oleellisilta osin 28 päivään mennessä oleellisilta osin 21 päivään mennessäimplantaatiosta laskettuna. implantaatiosta laskettuna.

Resorptio on oleellisilta osin täydellinen 90 –120 päivän kuluttua.

KONTRAINDIKAATIOTNäitä ommelaineita (sekä värjättyjä että värjäämättömiä) ei pitäisi resorboituvuuten-sa vuoksi käyttää silloin, kun kudosten yhteenliitoksen on kestettävä pitkäaikaistajännitystä. VÄRJÄÄMÄTÖNTÄ MONOCRYL®-ommelainetta ei saa käyttää vatsan-peitteiden eikä faskiakudosten sulkemiseen.

VAROITUKSET / VAROTOIMET / INTERAKTIOTMONOCRYL®-ompeleiden turvallisuutta ja tehoa ei ole varmistettu seuraavilla alu-eilla: hermokudos, kardiovaskulaarinen kudos, mikrokirurgia ja silmäkirurgia.MONOCRYL®-ommelainetta haavan sulkemiseen käyttävän on tunnettava leik-kaustoimenpiteet ja -tekniikat, joissa resorboituvia ommelaineita käytetään, koskahaavan avautumisriski vaihtelee paikan ja käytetyn ommelaineen mukaan. Ommel-aineen valinnassa on otettava huomioon sen ominaisuudet in vivo (ks kohta Omi-naisuudet). Tämä ommelaine ei ehkä sovi vanhuksille, vajaaravitsemuksesta kärsi-ville eikä huonokuntoisille potilaille eikä tiloissa, jotka voivat hidastaa haavan para-nemista.Pitkäaikaisessa kosketuksessa suolapitoisten liuosten, kuten virtsa- ja sappitie-nesteiden kanssa, ommelaineet - kuten kaikki vierasesineet - voivat aiheuttaa kivi-muodostusta. Resorboituvana ommelaineena MONOCRYL® voi vaikuttaa ohime-nevästi vierasesineen tavoin.Kontaminoituneiden tai infektoituneiden haavojen hoidossa on noudatettava ylei-sesti hyväksyttyä kirurgista käytäntöä.Koska MONOCRYL® on resorboituva ommelaine, kirurgin tulisi harkita resorboitu-mattomien lisäompeleiden käyttöä haavansulussa sellaisissa kohdissa, jotka voivatlaajeta, venyä tai pullistua tai vaatia lisätukea.Yli 7 päivää paikallaan olevat iho-ompeleet voivat aiheuttaa paikallisärsytystä ja nepitäisi katkaista tai poistaa. Ihonalaisompeleet tulisi tehdä mahdollisimman syvälleresorptioon normaalisti liittyvän punoituksen ja kovettumien minimoimiseksi.Joskus, lähinnä ortopedisissa toimenpiteissä, nivel voidaan immobilisoida ortoosillakirurgin harkinnan mukaan.Resorboituvia ommelaineita tulisi käyttää harkiten kudoksissa, joissa verenvirtauson vähäistä, koska ommel voi pullistua ja resorptio viivästyä.Kuten muitakin ommelaineita, myös MONOCRYL®-ommelainetta on käsiteltävä va-roen vaurioiden välttämiseksi. Varo puristamasta tai kähertämästä ommelainettakirurgisilla instrumenteilla, kuten pihdeillä tai neulankuljettimella.Solmut saadaan riittävän pitäviksi tavanomaisella ompelu- ja solmintatekniikalla sekälisäompeleilla leikkaustilanteen ja kirurgin kokemuksen mukaan. Lisäompeleidenkäyttö voi olla erityisen tarkoituksenmukaista yksisäikeisten ommelaineiden kohdal-la.

Leikkausneuloja on käsiteltävä varoen vahinkojen välttämiseksi. Tartu neulaan1/3 tai 1/2 etäisyydeltä langan kiinnityskohdasta kärkeen päin. Jos neulaantarttuu liian läheltä kärkeä, sen lävistyskyky voi heiketä ja neula voi katketa. Josneulaan tarttuu kannasta tai langan kiinnityskohdasta, se voi vääntyä tai katke-ta. Neulan muodon korjaaminen voi heikentää sen lujuutta ja altistaa senvääntymiselle tai katkeamiselle. Kirurgisia neuloja on käsiteltävä varoen tahat-tomien neulanpistojen välttämiseksi. Hävitä käytetyt neulat asianmukaisestineulasäiliössä.

HAITTAVAIKUTUKSETTämän tuotteen käyttöön liittyviä haittavaikutuksia ovat aluksi ohimenevä vä-häinen paikallisärsytys haavakohdassa, ohimenevä inflammatorinen vierase-sinereaktio, punoitus ja kovettumat ihonalaisompeleiden resorboituessa. Kaik-kien vierasesineiden tavoin myös MONOCRYL® voi pahentaa jo olemassa ole-vaa infektiota.

STERIILIYSMONOCRYL®-ommelaineet on steriloitu etyleenioksidilla. Ei saa steriloida uu-delleen. Ei saa käyttää, jos pakkaus on avattu tai vahingoittunut. Avattu, käyttä-mätön tuote on hävitettävä.

SÄILYTYSSuositeltavat säilytysolosuhteet: alle +25 °C:ssa kosteudelta ja suoralta läm-möltä suojattuna. Ei saa käyttää viimeisen käyttöpäivän jälkeen.

MERKITSEMISESSÄ KÄYTETTÄVÄT SYMBOLIT

= Kertakäyttöinen

= Käytettävä viimeistään – vuosi & kuukausi

= Tuote on steriili, kun pakkaus on avaamaton ja ehjä.Sterilointimenetelmä – Etyleenioksidi

0086 = CE-merkintä + ilmoitetun laitoksen tunnusnumero.Tuote täyttää Medical Device Directive 93/42/EEC:noleelliset vaatimukset.

= Eränumero

= Katso käyttöohjeet

LOT

Instructions f or use

MONOCRYL®(POLIGLECAPRONE 25)

STERILE SYNTHETIC ABSORB ABLE

SUTURE

DYED UNDYEDPost Implantation Approx. Original Post Implantation Approx. Original

Strength Remaining Strength Remaining7 days 60% 7 days 50%

14 days 30% 14 days 20%All of the original tensile strength is All of the original tensile strength isessentially lost by 28 days post-implantation. essentially lost by 21 days post-implantation.

Absorption is essentially complete between 90 and 120 days.

CONTRAINDICATIONSThese sutures (dyed and undyed), being absorbable, should not be used whereextended approximation of tissues under stress is required.MONOCRYL® UNDYED must not be used for abdominal closure or to closefascial tissue.

WARNINGS / PRECAUTIONS / INTERACTIONSThe safety and effectiveness of MONOCRYL® sutures has not been establishedin the following areas – neural tissue, cardiovascular tissue, microsurgery andophthalmic surgery.Users should be familiar with surgical procedures and techniques involving ab-sorbable sutures before employing MONOCRYL® suture for wound closure, asrisk of wound dehiscence may vary with the site of application and the suturematerial used. Surgeons should consider the in-vivo performance (under PER-FORMANCE section) when selecting a suture. This suture may be inappropriatein elderly, malnourished or debilitated patients, or in patients suffering fromconditions which may delay wound healing.As with any foreign body, prolonged contact of any suture with salt solutions, suchas those found in the urinary or biliary tracts, may result in calculus formation. Asan absorbable suture, MONOCRYL® may act transiently as a foreign body.Acceptable surgical practice should be followed for the management of contami-nated or infected wounds.As this is an absorbable suture material, the use of supplemental non-absorbablesutures should be considered by the surgeon in the closure of the sites whichmay undergo expansion, stretching or distension, or which may require additionalsupport.Skin sutures which must remain in place longer than 7 days may cause localizedirritation and should be snipped off or removed. Subcuticular sutures should beplaced as deeply as possible to minimize the erythema and induration normallyassociated with the absorption process.Under some circumstances, notably orthopaedic procedures, immobilization ofjoints by external support may be employed at the discretion of the surgeon.Consideration should be taken in the use of absorbable sutures in tissues withpoor blood supply as suture extrusion and delayed absorption may occur.In handling this or any other suture material, care should be taken to avoiddamage. Avoid crushing or crimping damage due to application of surgicalinstruments such as forceps or needle holders.Adequate knot security requires the standard surgical technique of flat and squareties with additional throws as indicated by surgical circumstance and theexperience of the surgeon. The use of additional throws may be particularlyappropriate when knotting any monofilament suture.

Care should be taken to avoid damage when handling surgical needles. Grasp theneedle in an area one third (1/3) to one half (1/2) of the distance from the attachmentend to the point.Grasping in the point area could impair the penetration performance and causefracture of the needle. Grasping at the butt or attachment end could cause bending orbreakage. Reshaping needles may cause them to loose strength and be lessresistant to bending and breaking. Users should exercise caution when handlingsurgical needles to avoid inadvertent needle stick injury. Discard used needles in‘Sharps’ containers.

ADVERSE REACTIONSAdverse effects associated with the use of this device include: transient local irritationat the wound site, transient inflammatory foreign body response, erythema andinduration during absorption with subcuticular sutures. Like all foreign bodiesMONOCRYL® may enhance an existing infection.

STERILITYMONOCRYL® sutures are sterilized by ethylene oxide gas. Do not re-sterilize. Do notuse if package is opened or damaged. Discard opened, unused sutures.

STORAGERecommended storage conditions: Below 25° C, away from moisture and direct heat.Do not use after expiry date.

DESCRIPTIONMONOCRYL® is a sterile synthetic absorbable monofilament suture prepared froma copolymer of glycolide and Â-caprolactone. The empirical molecular formula ofthe polymer is (C2H2O2)m (C6H10O2)n.Poliglecaprone 25 copolymer has been found to be non-antigenic, non-pyrogenicand elicits only a slight tissue reaction during absorption.MONOCRYL® sutures are dyed by adding D&C violet No.2 (Colour Index Number60725 ) during polymerization. Sutures are also available in the undyed form.MONOCRYL® is available in a range of gauge sizes and lengths, non-needled orattached to stainless steel needles of varying types and sizes. The needles maybe attached permanently or as CONTROL RELEASE which enables the needlesto be pulled off instead of being cut off. Full details of the product range arecontained in the catalogue.MONOCRYL® complies with all the requirements of the European Pharmaco-poeia for Sterile Synthetic Absorbable Monofilament Sutures and the requirementsof the United States Pharmacopoeia for Absorbable Surgical Sutures except for aslight oversize in diameter.

INDICATIONSMONOCRYL® sutures are intended for use in general soft tissue approximationand/or ligation where an absorbable material is indicated.

APPLICATIONSutures should be selected and implanted depending on patient condition, surgi-cal experience, surgical technique and wound size.

PERFORMANCEMONOCRYL® suture elicits a minimal initial inflammatory reaction in tissues andis eventually replaced with an ingrowth of fibrous connective tissue. Progressiveloss of tensile strength and eventual absorption of MONOCRYL® sutures occursby means of hydrolysis, where the polymer degrades to adipic acid which issubsequently absorbed and metabolized in the body. Absorption begins as loss oftensile strength followed by a loss of mass. Implantation studies in rats show thefollowing profile:

Gebrauc hsanweisun g

MONOCRYL®POLIGLECAPRON 25

STERILES SYNTHETISCHES RESORBIERBARES

NAHTMATERIALBESCHREIBUNGMONOCRYL® ist ein steriler synthetischer resorbierbarer monofiler Faden, deraus einem Copolymer aus Glycolid und Â-Caprolactam besteht. Die Summen-formel des Polymers lautet (C2H2O2)m(C6H10O2)n. Poliglecapron 25-Copolymerhat weder antigene noch pyrogene Eigenschaften und verursacht während derResorption lediglich eine geringe Gewebsreaktion. Durch Zusatz von D & CViolett Nr. 2 (Color Index Nummer 60725) während der Polymerisation wird MO-NOCRYL® violett gefärbt. Das Nahtmaterial ist auch ungefärbt erhältlich. MO-NOCRYL® Nahtmaterial steht in verschiedenen Stärken und Längen zur Verfü-gung. Darüber hinaus ist MONOCRYL® sowohl mit Edelstahlnadeln verschiede-ner Typen und Größen erhältlich. Die Nadeln sind entweder fest mit dem Fadenverbunden, oder es handelt sich um eine sogenannte CR (Control Release)-Nadel: Hier muß die Nadel nicht abgeschnitten, sondern kann vom Faden abge-zogen werden. Detailangaben können dem Katalog entnommen werden.MONOCRYL® entspricht den Anforderungen der Amerikanischen Pharma-kopöe (USP) für resorbierbare chirurgische Nahtmaterialien und der Europäi-schen Pharmakopöe für synthetische resorbierbare monofile Fäden. Lediglichbei einigen Fadenstärken wird die Durchmesserspanne der USP geringfügigüberschritten.

ANWENDUNGSGEBIETEMONOCRYL® ist für die Adaptation von Weichgeweben und/oder für Ligaturengeeignet, bei denen die Verwendung eines resorbierbaren Fadens indiziert ist.

ANWENDUNGBei Auswahl und Applikation des Nahtmaterials sollten Zustand des Patienten,Erfahrung des Arztes, chirurgische Technik sowie Wundgröße berücksichtigtwerden.

WIRKUNGMONOCRYL® Nahtmaterial verursacht eine minimale entzündliche Gewebsre-aktion, und es kommt zum Einsprossen von Bindegewebszellen. Die allmähli-che Abnahme der Reißkraft und die Resorption des MONOCRYL®-Nahtmateri-als sind eine Folge von hydrolytischen Vorgängen, bei denen das Polymer zuAdipinsäure abgebaut wird, die anschließend resorbiert und im Körper metabo-lisiert wird. Bei der Resorption kommt es zunächst zu einem Rückgang derReißkraft, gefolgt von einem Verlust an Masse.

Implantationsstudien bei Ratten ergeben folgendes Profil:VIOLETT UNGEFÄRBT

Nach Implantation Verbleibende Reißkraft Nach Implantation Verbleibende Reißkraft ca. ca.

7 Tage 60% 7 Tage 50%14 Tage 30% 14 Tage 20%

Die ursprüngliche Reißkraft ist 28 Tage post Die ursprüngliche Reißkraft ist 21 Tage postimplantationem vollständig verschwunden. implantationem vollständig verschwunden.

Zwischen dem 90. und 120. Tag ist die Resorption im wesentlichen abgeschlossen.

GEGENANZEIGENDa es sich bei MONOCRYL® (ungefärbt und violett) um resorbierbare chirurgischeFäden handelt, dürfen sie nicht verwendet werden, wenn eine dauerhafte Approxi-mation des Gewebes unter Belastung erforderlich ist.MONOCRYL® UNGEFÄRBT darf nicht für abdominale Verschlüsse oder zur Appro-ximation von Fasciengewebe eingesetzt werden.

WARNHINWEISE / VORSICHTSMASSNAHMEN / WECHSELWIRKUNGENFür die Sicherheit und Wirksamkeit von MONOCRYL® in neuronalem oderkardiovaskulärem Gewebe sowie in der Mikrochirurgie und Ophthalmologie liegennoch keine ausreichenden Erfahrungen vor. Der Anwender sollte mit den chirurgischen Techniken, bei denen resorbierbares Nahtmaterial verwendet wird,vertraut sein, bevor er MONOCRYL® zum Wundverschluß einsetzt, da das Risikoeiner Wunddehiszenz je nach Lokalisation der Wunde und verwendetem Nahtmaterial variieren kann. Bei der Wahl des Nahtmaterials sollte der Chirurg dessen in vivo-Eigenschaften berücksichtigen (siehe Abschnitt “WIRKUNG”). Beialten, unterernährten oder entkräfteten Patienten sowie bei Patienten, deren Krankheit eine verzögerte Wundheilung verursachen kann, ist MONOCRYL®

Nahtmaterial unter Umständen ungeeignet. Nahtmaterial kann – wie jeder andereFremdkörper – bei Kontakt mit salzhaltigen Lösungen (etwa in den Harn- oderGallenwegen) zur Steinbildung führen. Da es sich bei MONOCRYL® um resorbierbares Nahtmaterial handelt, kann auch MONOCRYL® vorübergehend alsFremdkörper wirken. Kontaminierte Wunden sollten entsprechend chirurgischversorgt werden. Da MONOCRYL® ein resorbierbares Nahtmaterial ist, sollte derChirurg bei Nähten, die unter Spannung stehen bzw. gedehnt werden oder weiterenHalt benötigen, gegebenenfalls zusätzlich nicht-resorbierbares Nahtmaterialverwenden. Hautnähte, die länger als sieben Tage in situ verbleiben müssen, könnenlokale Reizungen verursachen und sollten abgeschnitten bzw. entfernt werden.Intracutan sollte das Nahtmaterial so tief wie möglich plaziert werden, um Erythembildung und Induration, die i. allg. den Resorptionsprozeß begleiten, zu minimieren. Der postoperativen externen Ruhigstellung, insbesondere nach orthopädischen Operationen, steht die Verwendung des resorbierbaren Nahtmaterials MONOCRYL® nicht entgegen. In schlecht durchbluteten Geweben istbei der Verwendung von resorbierbarem Nahtmaterial Vorsicht angebracht, da eshier zu Abstoßung des Fadens und verzögerter Resorption kommen kann. Bei derHandhabung von chirurgischem Nahtmaterial jeder Art ist darauf zu achten, daßdieses nicht beschädigt wird. Bei Verwendung von chirurgischen Instrumenten wieZangen, Klemmen oder Nadelhaltern sind Schäden durch Quetschen oder Krümmen des Fadens zu vermeiden. MONOCRYL® Nahtmaterial ist je nachErfahrung des Chirurgen gemäß den üblichen chirurgischen Nahtmethoden und

Knüpftechniken zu verwenden, wenn eine entsprechende chirurgische Indikation vorliegt. Prinzipiell sollte – insbesondere bei synthetischen, monofilenNahtmaterialien – auf einen sicheren Knotensitz geachtet werden.Gegebenenfalls sind zusätzliche gegenläufige Sicherungsknoten zu setzen. Umdie Nadel bei der Handhabung nicht zu beschädigen, sollte sie immer im Bereichzwischen etwa 1/3 bis 1/2 der Länge vom armierten Ende zur Nadelspitze gefaßtwerden. Das Fassen der Nadel im Nadelspitzenbereich kann diePenetrationswirkung beeinträchtigen und zum Bruch der Nadel führen. DasFassen am armierten Ende kann Verbiegen und ebenfalls Bruch zur Folge haben. Das Verformen von Nadeln kann zu Stabilitätsverlust und damit zu reduzierter Biege- und Bruchresistenz führen. Bei jeder Handhabung von chirurgischen Nadeln ist durch besondere Vorsicht auf die Vermeidung von Stichverletzungen zu achten. Achten Sie auf die sachgerechte Entsorgung gebrauchter Nadeln mittels entsprechender geeigneter Behälter (“Sharps” o. ä.).

NEBENWIRKUNGEN Zu den unerwünschten Reaktionen, die bei Verwendung von MONOCRYL® auf-treten können, zählen: Vorübergehende lokale Reizung im Wundbereich, vor-übergehende entzündliche Gewebsreaktion auf den applizierten Fremdkörper,Erythembildung und Gewebeverhärtung während der Resorption der Intracutan-nähte. Wie bei allen Fremdkörpern kann eine präexistierende Infektion negativbeeinflußt werden.

STERILITÄTMONOCRYL® wird mit Ethylenoxid sterilisiert. Nicht resterilisieren! Geöffnete oderbeschädigte Packungen nicht verwenden! Geöffnete jedoch nicht verwendeteProdukte verwerfen!

LAGERBEDINGUNGENEmpfohlene Lagerungsbedingungen: unter 25° C, vor Feuchtigkeit und direkterHitze geschützt. Nicht nach Ablauf des Verfalldatums verwenden.

GB

SYMBOLS USED ON LABELLING

= Do not reuse

= Use until Year & Month

= Sterile unless package is opened or damaged.Method of Sterilization - Ethylene oxide

0086 = CE-mark and identification number of notified body.Product conforms to the essential requirements of the Medical Device Directive 93/42/EEC

= Batch Number

= See Instructions for Use

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D

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Essential Prescribing Information MERSILENE* Polyester Fiber Suture Nonabsorbable Surgical Suture, USP Except for size 6-0 diameter INDICATIONS MERSILENE Suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures. CONTRAINDICATIONS None known. WARNINGS Users should be familiar with surgical procedures and techniques involving nonabsorbable sutures before employing MERSILENE Suture for wound closure, as risk of wound dehiscence may vary with the site of application and the suture material used. Do not resterilize. Discard opened packages and unused sutures. As with any foreign body, prolonged contact of any suture with salt solutions, such as those found in the urinary or biliary tracts, may result in calculus formation. Acceptable surgical practice should be followed for the management of infected or contaminated wounds. PRECAUTIONS In handling this or any other suture material, care should be taken to avoid damage from handling. Avoid crushing or crimping damage due to application of surgical instruments such as forceps or needle holders. The use of additional throws is particularly appropriate when knotting monofilament sutures. As with any suture material, adequate knot security requires the accepted surgical technique of flat and square ties with additional throws as warranted by surgical circumstance and the experience of the surgeon. To avoid damaging needle points and swage areas, grasp the needle in an area one-third (1/3) to one-half (1/2) of the distance from the swaged end to the point. Reshaping needles may cause them to lose strength and be less resistant to bending and breaking. Users should exercise caution when handling surgical needles to avoid inadvertent needle sticks. Discard used needles in sharps" containers. ADVERSE REACTIONS Adverse effects associated with the use of this device include wound dehiscence, calculi formation in urinary and biliary tracts when prolonged contact with salt solutions such as urine and bile occurs, infection, minimal acute inflammatory tissue reaction and

transitory local irritation at the wound site. Broken needles may result in extended or additional surgeries or residual foreign bodies. Inadvertent needle sticks with contaminated surgical needles may result in the transmission of bloodborne pathogens. See Package Insert for Full Prescribing Information. *Trademark

Essential Prescribing Information ETHILON* Nylon Suture Nonabsorbable Surgical Sutures, USP INDICATIONS ETHILON suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures. CONTRAINDICATIONS Due to the gradual loss of tensile strength which may occur over prolonged periods in vivo, nylon suture should not be used where permanent retention of tensile strength is required. WARNINGS Users should be familiar with surgical procedures and techniques involving nonabsorbable sutures before employing ETHILON suture for wound closure, as the risk of wound dehiscence may vary with the site of application and the suture material used. As with any foreign body, prolonged contact of any suture with salt solutions, such as those found in the urinary or biliary tracts, may result in calculus formation. Acceptable surgical practice should be followed for the management of contaminated or infected wounds. Do not resterilize. Discard open packages and unused sutures. PRECAUTIONS In handling this or any other suture material, care should be taken to avoid damage from handling. Avoid crushing or crimping damage due to application of surgical instruments such as forceps or needle holders. As with any suture material, adequate knot security requires the accepted surgical technique of flat and square ties, with additional throws as warranted by surgical circumstance and the experience of the surgeon. The use of additional throws may be particularly appropriate when knotting monofilaments. To avoid damaging needle points and swage areas, grasp the needle in an area one-third (1/3) to one-half (1/2) of the distance from the swaged end to the point. Reshaping needles may cause them to lose strength and be less resistant to bending and breaking. Users should exercise caution when handling surgical needles to avoid inadvertent needle sticks. Discard used needles in "sharps" containers. ADVERSE REACTIONS Adverse effects associated with the use of this device include wound dehiscence, gradual loss of tensile strength over time, calculi formation in urinary and biliary tracts when prolonged contact with salt solutions such as urine and bile occurs, infection,

minimal acute inflammatory tissue reaction, and transitory local irritation at the wound site. Broken needles may result in extended or additional surgeries or residual foreign bodies. Inadvertent needle sticks with contaminated surgical needles may result in the transmission of bloodborne pathogens. See Package Insert for Full Prescribing Information. *Trademark

Essential Prescribing Information ETHIBOND EXCEL* Polyester Suture NONABSORBABLE SURGICAL SUTURE, USP Except for size 6-0 diameter INDICATIONS ETHIBOND EXCEL Suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures. CONTRAINDICATIONS None known. WARNINGS Users should be familiar with surgical procedures and techniques involving nonabsorbable sutures before employing ETHIBOND EXCEL Suture for wound closure, as risk of wound dehiscence may vary with the site of application and the suture material used. Do not resterilize. Discard opened packages and unused sutures. As with any foreign body, prolonged contact of any suture with salt solutions, such as those found in the urinary or biliary tracts, may result in calculus formation. Acceptable surgical practice should be followed for the management of infected or contaminated wounds. PRECAUTIONS In handling this or any other suture material, care should be taken to avoid damage from handling. Avoid crushing or crimping damage due to application of surgical instruments such as forceps or needle holders. As with any suture material, adequate knot security requires the accepted surgical technique of flat and square ties with additional throws as warranted by surgical circumstance and the experience of the surgeon. To avoid damaging needle points and swage areas, grasp the needle in an area one-third (1/3) to one-half (1/2) of the distance from the swaged end to the point. Reshaping needles may cause them to lose strength and be less resistant to bending and breaking. Users should exercise caution when handling surgical needles to avoid inadvertent needle sticks. Discard used needles in "sharps" containers. ADVERSE REACTIONS Adverse effects associated with the use of this device include wound dehiscence, calculi formation in urinary and biliary tracts when prolonged contact with salt solutions such as urine and bile occurs, infection, minimal acute inflammatory tissue reaction and transitory local irritation at the wound site. Broken needles may result in extended or additional surgeries or residual foreign bodies. Inadvertent needle sticks with contaminated surgical needles may result in the transmission of bloodborne pathogens. See Package Insert for Full Prescribing Information. *Trademark

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