hemofarm vademekum engleska verzija za 2013
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Hemofarm Vademekum engleska verzija za 2013.godinu.TRANSCRIPT
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Vademecum
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A ALIMENTARY TRACT & METABOLISMA02 DRUGS FOR ACID RELATED DISORDERS A02B DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX (GORD)A02BA H2-RECEPTOR ANTAGONISTSA02BA02 ranitidine
RanitidineAntiulcerant
Brand name INN
Ranitidine ranitidine hydrochloride
ATC DDD Pregnancy
A02BA02 O, P 0,3 g B
Form and package Lactation
Film coated tablets 20 x 150 mgeff. tablets 20 x 150 mginj. 5 x 50 mg/2 ml
Unknown effects on infants exposed. No evidence of harmfulness. Excreted into milk.
INDICATIONSGastric ulcer•Duodenal ulcer•Gastrooesophageal reflux disease (GORD)•Erosive o• esophagitis.Zollinger-Ellison syndrome• and other related conditions (systemic mastocytosis )Other conditions where is hyperacidity important •disturbance for patientBleeding from upper part of digestive tract (only for •parenteral form)
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A02BA03 famotidine
FamotidineH2-receptor antagonist
Brand name INN
Famotidine famotidine
ATC DDD Pregnancy
A02BA03 O, P 0,04 g B
Form and package Lactation
Film coated tablets 30 x 20 mg film coated tablets 30 x 40 mg
Caution, the lowest excretion of all H2-receptor antagonists
INDICATIONSGastric and duodenal ulcers•Reflux oesophagitis•Zollinger-Ellison syndrome•Non-ulcus dyspepsia•
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A02BC PROTON PUMP INHIBITORS A02BC01 omeprazole
Omeprazolproton pump inhibitor
Brand name INN
Omeprazol omeprazole
ATC DDD Pregnancy
A02BC01 O 20 mg C
Form and package Lactation
gastroresistant capsules 14 x 20 mggastroresistant capsules 15 x 20 mg
It is excreted into breast milk, avoid
INDICATIONSOmeprazole gastroresistant capsules are indicated for:Adults:• treatment of duodenal ulcer• prevention of relapse of duodenal ulcers• treatment of peptic ulcers• prevention of relapse of peptic ulcers• treatment of peptic ulcers caused by Helicobacter pylori (H.
pylori) in combination with an appropriate antibiotic
• treatment of duodenal and peptic ulcers resulting from the use of NSAIDs
• prevention of peptic and duodenal ulcers in patients on NSAIDs who are at risk
• treatment of reflux oesophagitis• long-term therapy in patients with healed reflux
oesophagitis• treatment of symptomatic gastro-oesophageal reflux
disease• treatment of Zollinger-Ellison syndromeChildren (over 1 year and BW ≥ 10 kg):• treatment of reflux oesophagitis• symptomatic treatment of heartburn and regurgitation of
acid in gastro-oesophageal reflux diseaseChildren (over 4 years) and adolescents• In combination with antibiotic treatment of duodenal ulcers
caused by H. pylori
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A02BC03 lansoprazole
Sabaxproton pump inhibitor
Brand name INN
Sabax lansoprazole
ATC DDD Pregnancy
A02BC03 O 30 mg B
Form and package Lactation
capsules 28 x 15 mgcapsules 14 x 30 mg
Potential toxic. Possible suppression of gastric secretion
INDICATIONSGastrooesophageal reflux•Benign gastric ulcus •Duodenal ulcer•Dyspepsia with hyperacidity•Therapy and prophylaxis of ulcus associated with long •term use of NSAID Hypersecretory conditions including • Zollinger-Ellison syndromeReflux oesophagitis•Helicobacter pylori• eradication (in combination with appropriate antibiotics)
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Laktuloza Osmotic laxative
Brand name INN
Laktuloza lactulose
ATC DDD Pregnancy
A06AD11 O 6,7 g B
Form and package Lactation
Bottle with 200 ml syrupBottle with 500 ml syrup
Can be used.
INDICATIONSChronic constipation.•Hepatic encephalopathy (portal encephalopathy); •hepatic coma.
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A10B ORAL ANTIDIABETICS (drugs which lowered glucose level in blood)A10BA BIGUANIDE ANTIDIABETICSA10BA02 metformin
Gluforminoral antidiabetic
Brand name INN
Gluformin metformin hydrochloride
ATC DDD Pregnancy
A10BA02 O 2 g B
Form and package Lactation
tablets 30 x 500 mgtablets 30 x 1000 mg
Avoid
INDICATIONS• Noninsulin-dependent diabetes mellitus (type II,
NIDDM), especially in overweight patients, whose glucose metabolism are not adequately controlled with diet and exercise.
• For treating noninsulin-dependent diabetes mellitus (Type II) in combination with sulfonylureas; strictly take care about contraindications.
In patients with normal body weight and NIDDM, Gluformin can used like monotherapy, or in combination with sulphonylurea antidiabetics, and on this way is possible to avoid use of insulin. Gluformin also might be combined with insulin. It is very important that through therapy with Gluformin, body weight not enlarged; in some cases body weight can to fall off.
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A10BB SULPHONYLUREA ANTIDIABETICS A10BB09 gliclazide
Diprianoral antidiabetic
Brand name INN
Diprian gliclazide
ATC DDD Pregnancy
A10BB09 O 0,16 g C
Form and package Lactation
tablets 30 x 80 mg Avoid
INDICATIONSNoninsulin-dependent diabetes mellitus (type II, •NIDDM) in adults, whose glucose metabolism are not adequately controlled with diet.
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Reguly oral antidiabetic
Brand name INN
Reguly repaglinide
ATC DDD Pregnancy
A10BX02 O 4 mg C
Form and package Lactation
tbl. 30 x 0,5 mgtbl. 30 x 1 mgtbl. 30 x 2 mg
No data, avoid
INDICATIONSRepaglinide is indicated in patients with type II diabetes (insulin-independent diabetes mellitus) whose hyperglycaemia can no longer satisfactorily controlled regime of diet, weight loss and physical activity.Repaglinide in combination with metformin, is also indicated in patients with type II diabetes whose blood glucose is not properly regulated using only metformin.Begin therapy in addition to diet and physical activity, and adjust to meal.
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B BLOOD AND FORMING ORGANS, DRUGS FOR TREATMENT OF DISEASES OF BLOOD AND FORMING ORGANSB01 ANTITHROMBOTIC DRUGS (ANTICOAGULANTS) B01A ANTITHROMBOTIC DRUGS (ANTICOAGULANTS) B01AC INHIBITORS OF THROMBOCYTES AGGREGATION, EXCLUDING HEPARINEB01AC04 clopidogrel
Clopidix Inhibitor of thrombocytes aggregation
Brand name INN
Clopidix clopidogrel
ATC DDD Pregnancy
B01AC04 O 75 mg B
Form and package Lactation
film-coated tablets 28 x75mg Avoid
INDICATIONS Clopidogrel is used in adults for the prevention atherotrombotic events:- Patients who have had a myocardial infarction (from a few up to 35 days), ischemic stroke (between 7 days to a maximum of 6 months) or have a confirmed peripheral artery disease.- In patients with acute coronary syndrome:- Acute coronary syndrome without ST-segment elevation (unstable angina or nonQ myocardial infarction), including patients with stents after percutaneous coronary intervention, in combination with acetylsalicylic acid.- Acute myocardial infarction with ST-segment elevation, in combination with aspirin in patients who have conditions for treatment with thrombolytics.
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B01AC05 ticlopidine
Ticlodix Inhibitor of thrombocytes aggregation
Brand name INN
Ticlodix ticlopidine
ATC DDD Pregnancy
B01AC05 O 0,5 g B
Form and package Lactation
film tablets 30 x 250 mg Avoid
INDICATIONS Ticlodix tablets used in the secondary prophylaxis of thromboembolic complications:
• Cerebrovascular disease, • Ischemic heart disease, • Peripheral arterial disease with claudication, • After coronary artery bypass • In patients on hemodialysis with arteriovenous cannula, • Surgical procedures using the extracorporeal circulation.
Ticlodix should be used in patients who can not use aspirin (Ticlodix use is related to the manifestation of life-threatening side effects of blood dyscrasia, including thrombotic thrombocytopenic purpura – TTP).
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B03 ANTI-ANAEMIC PREPARATIONSB03X OTHER ANTI-ANAEMIC PRODUCTSB03XA OTHER ANTI-ANAEMIC PRODUCTSB03XA01 epoetinum zeta
EqralysEpoetinum zeta
Brand name INN
Eqralys epoetinum zeta
ATC DDD Pregnancy
B03XA01 P 1000 I.U. C No data available
Form and package Lactation
solution for injection 10000 I.U./1mlsolution for injection 20000 I.U./0,5mlsolution for injection 30000 I.U./0,75mlsolution for injection 6 x 1000 I.U./0,3mlsolution for injection 6 x 2000 I.U./0,6mlsolution for injection 6 x 4000 I.U./0,4ml
Avoid,no data available
INDICATIONS• Treatment of anaemia associated with chronic renal
failure in adult and paediatric patients on haemodialysis and adult patients on peritoneal dialysis.
• Treatment of severe anaemia of renal origin accompanied by clinical symptoms in adult patients with renal insufficiency not yet undergoing dialysis.
• Treatment of anaemia and reduction of transfusion requirements in adult patients receiving chemotherapy for solid tumours, malignant lymphoma or multiple myeloma, and at risk of transfusion as assessed by the patient’s general status (e.g. cardiovascular status, pre-existing anaemia at the start of chemotherapy).
• Eqralys can be used to increase the yield of autologous blood from patients in a predonation programme. Its use in this indication must be balanced against the reported risk of thromboembolic events. Treatment should only be given to patients with moderate anaemia (haemoglobin (Hb) 10-13 g/dl [6.2-8.1 mmol/l], no iron deficiency), if blood saving procedures are not available or insufficient when the scheduled major elective surgery requires a large volume of blood (4 or more units of blood for females or 5 or more units for males).
• Eqralys can be used to reduce exposure to allogenic blood transfusions in adult non iron deficient patients prior to major elective orthopaedic surgery, having a high perceived risk for transfusion complications. Use should be restricted to patients with moderate anaemia (e.g. Hb 10 - 13 g/dl) who do not have an autologous predonation programme available and with an expected blood loss of 900 to 1800 ml.
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B05 SOLUTION FOR BLOOD SUBSTITUTE AND PERFUSION SOLUTIONSB05A BLOOD AND KRV I SIMILAR SOLUTIONB05AA07 hydroxyethyl starch, sodium chloride
Hetasorb 6%Hetasorb10%plasma expander
Brand name INN
Hetasorb 6%Hetasorb 10 % HAES , NaCl
ATC DDD Pregnancy
B05AA07 Not recomended
Form and package Lactation
Inf.solution 500 mlInf. solution 500 ml
Caution, Not enough data
INDICATIONS• Treatment and prevention of hypovolemia and shock after
operations, injuries, infections and burns.• Normovolemic hemodilution.• To compensate for the volume of cerebral disorders,
retinal and cochlear blood flow.
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B05B I.V. SOLUTIONS B05BA SOLUTIONS FOR PARENTERAL NUTRITIONB05BA01 amino acids
Aminosol 10%infusion solution
Brand name INN
Aminosol 10% amino acids
ATC DDD Pregnancy
B05BA01 C
Form and package Lactation
bottle 500 ml Avoid
INDICATIONSAminosol 10% infusion solution used together with fat emulsions, electrolytes and carbohydrates as a part of partial or total parenteral nutrition; for prophylaxis and therapy of protein and water loss in cases when the inability of enteral nutrition is present.Infusion solution is indicated in severe gastroinestinal diseases (ileus, peritonitis, malapsorption, bowel inflammation, pancreatitis, enterocutaneous phystulas), hypercatabolic status (traumas, burns, sepsis) and other diseases (anorexia nervosa, malignant diseases), in preoperative and postoperative period.
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B05BA10 aminoacids, minerals
Aminosol 15%infusion solution
Brand name INN
Aminosol 15% amino acids
ATC DDD Pregnancy
B05BA01 C
Form and package Lactation
bottle 500 ml Avoid
INDICATIONSAminosol 15% infusion solution used together with fat emulsions, electrolytes and carbohydrates as a part of partial or total parenteral nutrition; for prophylaxis and therapy of protein and water loss in cases when the inability of enteral nutrition is present.Infusion solution is indicated in severe gastroinestinal diseases (ileus, peritonitis, malapsorption, bowel inflammation, pancreatitis, enterocutaneous phystulas), hypercatabolic status (traumas, burns, sepsis) and other diseases (anorexia nervosa, malignant diseases), in preoperative and postoperative period.
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Aminosol 10% Einfusion solution
Brand name INN
Aminosol 10% E amino acids
ATC DDD Pregnancy
B05BA10 C
Form and package Lactation
bottle 500 ml Avoid
INDICATIONSAminosol 10% E infusion solution used together with fat emulsions, electrolytes and carbohydrates as a part of partial or total parenteral nutrition; for prophylaxis and therapy of protein and water loss in cases when the inability of enteral nutrition is present.Infusion solution is indicated in severe gastroinestinal diseases (ileus, peritonitis, malapsorption, bowel inflammation, pancreatitis, enterocutaneous phystulas), hypercatabolic status (traumas, burns, sepsis) and other diseases (anorexia nervosa, malignant diseases), in preoperative and postoperative period.
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B05BA.01 alanine, arginine, cysteine, phenilalanine, glycine, histidine, isoleucine, leucine, lysine, methionin, proline, serine, acetate acid, threonine, triptophan, valine
Hepasol 8%infusion solution
Brand name INN
Hepasol 8 %
alanine, arginine, cysteine, phenilalanine, glycine, histidine, isoleucine, leucine, lysine, methionin, proline, serine, acetate acid, threonine, triptophan, valine
ATC DDD PregnancyB05A01 C
Form and package Lactationbottle 1 x 500 ml Avoid
INDICATIONSLiver insufficiance with or without disturbances of •cerebral functions (encephalopathy)Hepatic coma or precomatous conditions.•
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B05BC SOLUTIONS PRODUCING OSMOTIC DIURESIS B05BC01 mannitol
Mannitolosmotic diuretic
Brand name INN
Mannitol mannitol
ATC DDD Pregnancy
B05BC01 P 40 g No data available
Form and package Lactation
Mannitol 10 % bottle 500 ml Mannitol 20 % bottle 250 ml
Avoid
INDICATIONSPrevention of anuria after: incidental transfusion, large •trauma, bleeding, surgery and burns Increased intracranial pressure: brain tumors, brain •oedema, head injuries Increased intraocular pressure •Poisoning with barbiturates and salicilates •Heavy oedema, ascites caused by liver cirrhosys with •use of saliuretics and aldosterone. Hypoglicemic coma•
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B05C IRRIGATING SOLUTIONSB05CX OTHER IRRIGATING SOLUTIONSB05CX10 mannitol, sorbitol
IspirolFor Flushing of the bladder
Brand name INN
Ispirol mannitol, sorbitol
ATC DDD Pregnancy
B05CX10 C
Form and package Lactation
Solution for external use (PVC bag) 1 x 5000 ml (0,54%+2,70%)
Caution
INDICATIONSIspirol is only used in urology to flush the bladder •during transurethral resection of the prostate and other transurethral procedures.
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C CARDIOVASCULAR SYSTEMC01 CARDIAC THERAPYC01B ANTI-ARRHYTHMICS, CLASS I AND IIIC01BC Anti-arrythmics, group I CC01BC03 propafenon
Propafenanti-arrhythmic (class I C)
Brand name INNPropafen propafenon
ATC DDD PregnancyC01BC03 O, P 0,3 g C
Form and package LactationFilm coated tablets 50 x 150 mgFilm coated tablets 50 x 300 mginj. 10 x 35 mg/10 ml
Avoid
INDICATIONSAll form of ventricular and supraventricular •extrasystolas Ventricular and supraventricular tachicardias and •tachiarrhythmias Wolff-Parkinson-White• syndrome (WPW).
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C01D VASODILATATORS USED IN CARDIAC DISEASES C01DA ORGANIC NITRATES C01DA05 pentaerithrityltetranitrate (pentanitrole)
Dilcoran 80antianginic with prolonged action
Brand name INNDilcoran 80 pentaerithrityltetranitrate
(pentanitrole)
ATC DDD PregnancyC01DA05 O 0,12 g C
Form and package Lactationretard tablets 20 x 80 mg Avoid
INDICATIONSLong term therapy of ischaemic heart disease•Prophylaxis of angina pectoris•Additional therapy: chronic cor pulmonare and chronic •heart failure
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C01DA14 isosorbide mononitrate
Monizolantianginic (vasodilatator)
Brand name INNMonizol Isosorbide mononitrate
ATC DDD PregnancyC01DA14 O 0,04 g C
Form and package Lactationtablets 30 x 20 mgtablets 30 x 40 mg Avoid
INDICATIONSProphylaxis of angina pectoris attack•Coronary arteries spasm removal (Prinzmetal angina)•Chronic heart failure •
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C02 ANTIHYPERTENSIVESC02A CENTRALY ACTING ANTIADRENERGICS C02AB METHYLDOPAC02AB02 methyldopa
MethyldopaAntihypertensive
Brand name INNMethyldopa methyldopa
ATC DDD PregnancyC02AB02 O 1 g B
Form and package LactationFilm coated tablets 20 x 250 mg Caution
INDICATIONSHypertension of different ethiology (except •phaeochromocythoma).
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C03 DIURETICSC03B WEAK DIURETICS, EXCLUDING THIAZIDESC03BA MONOCOMPONENT SULPHONAMIDE DIURETICSC03BA11 indapamide
IndapresDiuretic
Brand name INNIndapres indapamide
ATC DDD PregnancyC03BA11 O 0,0025 g B
Form and package Lactationtablets 30 x 2,5 mg Avoid
INDICATIONSArterial hypertension (mild to moderate, like •monotherapy, or in combination with other antihypertensives)Water and electrolytes retention (oedema in congestive •heart diseases).
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Indapres SRdiuretic
Brand name INNIndapres® SR indapamide
ATC DDD PregnancyC03BA11 O 0,0025 g B
Form and package LactationFilm coated retard tablets 30 x 1,5 mg Avoid
INDICATIONSTherapy and control of essential hypertension.•
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C03E POTASSIUM-SPARING AGENTS WITH OTHER DIURETICS C03EA THIAZIDES AND POTASSIUM-SPARING DIURETICS C03EA01 PRODUCTS WHICH CONTENTS CORTICOSTEROIDSC03EA01 hydrochlorothiazide, amiloride hydrochloride
Hemopresdiuretic combination
Brand name INNHemopres hydrochlorothiazide,amiloride
hydrochloride
ATC DDD PregnancyC03EA01 O (0,05+0,005)g D
Form and package Lactationtablets 40 (50+5) mg Avoid
INDICATIONSArterial hypertension•Congestive heart failure with hypokaliemia •Liver cirrhosys with ascites •
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C04AE ERGOT ALCALOIDSC04AE01 ergoloid mesilate (dihydroergotoxine)
RedizorkVasodilatator
Brand name INNRedizork dihydroergotoxine
ATC DDD PregnancyC04AE01 O, P 0,003 g X
Form and package Lactationtablets 20 x 1,5 mgtablets 20 x 4,5 mg Avoid
INDICATIONSSenile cerebral insufficiency•Acute ischaemic stroke•Status after apoplectic stroke or traumatic brain •damage. Hypertension in older persons, in patients with •cerebrovascular insufficiency
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C07 BETA-BLOCKING AGENTSC07A BETA-BLOCKING AGENTSC07AB SELECTIVE BETA-BLOCKING AGENTSC07AB02 metoprolol
Presololbeta1 receptors blocker
Brand name INNPresolol metoprolol tartrate
ATC DDD PregnancyC07AB02 O, P 0,15g C, D in 2nd and 3rd trimester
Form and package Lactationf. c. tablets 30 x 100 mg f. c. tablets 28 x 50 mgf. c. tablets 56 x 50 mginj. 5 x 5ml/5mg
Caution
INDICATIONSHypertension•Angina pectoris•Myocardial infarction and secondary prevention of •myocardial infarctionArrhythmias (supraventricular tachiarrhytmias)•Hyperthireoidism (like additional therapy)•Prevention of migraines•Chronic heart failure •
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Tensec selective blocator beta adrenergic receptors
Brand name INNTensec bisoprolol
ATC DDD PregnancyC07AB07 O 10 mg C
Form and package Lactationfilm tablets 30 x 5 mg film tablets 30 x 10 mg
Caution, excreted in milk
INDICATION• Hipertension• Chronic stable angina pectoris.
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Tensec Plus selective blocator beta adrenergic receptors with thiazides
Brand name INNTensec Plus Bisoprolol, HCTZ
ATC DDD PregnancyC07BB07 C
Form and package Lactationfilm tablets 30 x (5 mg+12,5 mg) Caution, excreted in milk
INDICATIONS• Essential hypertension• The fixed combination is indicated in patients in whom
blood pressure is not adequately controlled by the individual components - bisoprolol and hydrochlorothiazide.
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C07AG BLOCATORS OF ALPHA AND BETA ADRENERGIC RECEPTORSC07AG02 carvedilol
Milenolalpha and beta blocker
Brand name INNMilenol carvedilol
ATC DDD PregnancyC07AG02 O 0,0375 g C
Form and package Lactationtablets 28 x 12,5 mgtablets 28 x 25 mg Avoid
INDICATIONSMild to moderate arterial hypertension•Angina pectoris•Chronic heart failure•
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C08 CALCIUM ANTAGONISTSC08C SELECTIVE CALCIUM ANTAGONISTS WITH DIRECT ACTION ON HEARTC08CA DIHYDROPIRIDINE DERIVATESC08CA01 amlodipine
Vazotalcalcium antagonist
Brand name INNVazotal amlodipine
ATC DDD PregnancyC08CA01 O 0,005 g C
Form and package Lactationtablets 20 x 5 mgtablets 20 x 10 mg Avoid
INDICATIONSArterial hypertension•Stable, chronic angina pectoris•Vasospastic angina Prinzmetal type•
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Cornelin calcium antagonist
Brand name INNCornelin lercanidipine
ATC DDD PregnancyC08CA13 10 mg O B
Form and package Lactationfilm tablets 28 po 10 mgfilm tablets 28 po 20 mg
Avoid, low concentration recorded in milk
INDICATIONSMild to moderate essential arterial hypertension•
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C08D SELECTIVE CALCIUM ANTAGONISTS WITH DIRECT ACTION ON HEARTC08DA PHENYLALKILAMINE DERIVATESC08DA01 verapamil
Verapamilcalcium antagonist
Brand name INNVerapamil verapamil hydrochloride
ATC DDD PregnancyC08DA01 O 0,24 g C
Form and package LactationFilm coated retard tablets 30 x 40 mgfilm coated retard tablets 50 x 80 mg
Caution, excretion in milk
INDICATIONSAngina pectoris (all types)•Arrythmias (chronic flutter and supraventricular •fibrilation)Prophylaxis of paroxismal supraventricular tachycardias•Essential hypertension•
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Cortiazem retard calcium antagonist
Brand name INNCortiazem retard diltiazem
ATC DDD PregnancyC08DB01 O 0,24 g C
Form and package LactationRetard tablets 30 x 90 mg Avoid
INDICATIONS• Chronic treatment of arterial hypertension• Chronic treatment of coronary artery disease• Prophylaxis of angina pectoris• Vasospastic angina (Prinzmetal’s angina)• Angina pectoris in the situation after myocardial
infarction• Non Q infarct
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C09 AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEMC09A ACE INHIBITORS, PLAIN C09AA ACE INHIBITORS, PLAIN C09AA01 captopril
ZorkaptilACE inhibitor
Brand name INNZorkaptil captopril
ATC DDD PregnancyC09AA01 O 0,05g D
Form and package Lactationtablets 40 x 12,5 mgtablets 40 x 25 mgtablets 40 x 50 mg
Caution
INDICATIONSArterial hypertension (monotherapy or in combination •with thiazide diuretics)Congestive heart failure (with cardiotonics and •diuretics)Myocardial infarction •Diabetic nephropathia.•
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C09AA05 ramipril
Prilinda ACE inhibitor
Brand name INN
Prilinda ramipril
ATC DDD Pregnancy
C09AA05 O 2,5 mg C, D in 2. and 3. trimester
Form and package Lactation
Tablets 28 x 2,5 mgTablets 28 x 5 mg
Not enough data, it is probably in the milk
INDICATIONS• Essential hypertension (mild to moderate)• Congestive heart failure• Congestive heart failure after acute myocardial infarction• Prophylaxis: reducing the risk of myocardial infarction,
stroke or cardiovascular death or need for revascularization procedures in patients with clinically proven cardiovascular disease (with or without previous MI), stroke or peripheral vascular disease
• Prophylaxis: reducing the risk of myocardial infarction, stroke or cardiovascular death or need for revascularization procedures in diabetic patients with clinically proven previous cardiovascular disease
• The initial non-diabetic or diabetic nephropathy• Manifest non-diabetic or diabetic nephropathy
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C09AA02 enalapril
Prilenapantihipertensive
Brand name INNPrilenap enalapril maleate
ATC DDD PregnancyC09AA02 O 0,01 g D
Form and package Lactationtablets 20 x 10 mg tablets 20 x 20 mg
Caution
INDICATIONSArterial hypertension•Congestive heart failure.•
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C09B ACE INHIBITORS, COMBINATIONC09BA ACE INHIBITORS AND DIURETICSC09BA02 enalapril, hydrochlorothiazide
Prilenap HL, Prilenap Hantihipertensive
Brand name INNPrilenap HL, Prilenap H enalapril, hydrochlorothiazide
ATC DDD PregnancyC09BA02 D
Form and package Lactationtablets 20 x (10+12,5) mgtablets 20 x (10 + 25) mg
Avoid
INDICATIONSAll forms of essential hypertension, when combined •therapy is necessary
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C09AA06 quinapril
Hemokvin ACE-ihibitor
Brand name INNHemokvin quinapril
ATC DDD Pregnancy
C09AA06 O, P, 0,015 g C (D in 2. and 3. trimester)
Form and package Lactationfilm tablets 20 po 10 mgfilm tablets 20 po 20 mg Caution
INDICATIONArterial hypertension•Heart failure•Myocardial infarction•
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C09BA06 quinapril, hydrochlorothiazide
Hemokvin plus quinapril, hydrochlorothiazide
Brand name INN
Hemokvin plus quinapril, hydrochlorothiazide
ATC DDD Pregnancy
C09BA06 O 2,5 mg C (D in 2. and 3. trimester)
Form and package Lactation
Film tabletas 20 x (20,0+12,5 mg) Caution
INDICATIONHemokvin Plus is indicated for the treatment of all forms of essential hypertension, when needed combination therapy (for patients whose blood pressure was previously not normalized with individual ingredients of the preparation).
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C09AA08 cilazapril
ZoboxACE inhibitor
Brand name INNZobox cilazapril
ATC DDD PregnancyC09AA08 O 2,5 mg D
Form and package LactationFilm coated tablets 30 x 2,5mgFilm coated tablets 30 x 5mg
Avoid. Not enough data in literature
INDICATIONS• Therapy of hypertension• Therapy of congestive heart failure ( in combination with
digitalis and/or diuretics).
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C09C ANGIOTENSIN II RECEPTOR ANTAGONISTS, PLAINC09CA ANGIOTENSIN II RECEPTOR ANTAGONISTS, PLAINC09CA01 losartan
Erynormangiotensin II receptor antagonist
Brand name INN
Erynorm losartan
ATC DDD Pregnancy
C09CA01 50 mg OC (D in 2nd and 3rd trimester). When pregnancy is detected, losartan should be discontinued as soon as possible.
Form and Package Lactation
Film coated tablets 28 x 50 mg Film coated tablets 28 x 100 mg
Because of the potential for adverse effects on the nursing infant, losartan should be avoided
INDICATIONS• Hypertension• Hypertensive patients with left ventricular hypertrophy (In hypertensive patients with left ventricular hypertrophy
a reduced risk of stroke was demonstrated. The data do not support the use of losartan for this indication in black patients)
• Renal protection in type 2 diabetic patients with nephropathy (macroalbuminuria)
(Losartan delays the progression of renal disease as measured by a reduction in the combined incidence of doubling of serum creatinine, end stage renal disease (need for dialysis or renal transplantation) or death; and to reduce proteinuria)
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Irbenida angiotensin II receptor antagonist
Brand name INN
Irbenida irbesartan
ATC DDD Pregnancy
C09CA04 O 0,15 g C (first trimester), D
Form and Package Lactation
f.c. tbl. 30x 150 mgf.c. tbl. 30 x 300 mg Avoid
INDICATIONS• Irbesartan is used in the treatment of• essential hypertension• diabetic nephropathy in patients with hypertension and
type 2 diabetes as part of the antihypertensive regimen
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C09DA01 losartan potassium + hydrochlorothiazide
Erynorm plus angiotensin II receptor antagonist, hydrochlorothiazide
Brand name INN
Erynorm plus losartan-potassium,hydrochlorothiazide
ATC DDD Pregnancy
C09DA01 1 tabletsC, D in the second and 3 trimester. Discontinue drug if pregnancy is estab-lished
Form and Package Lactation
Film-coated tablets28 x (50 mg+12,5 mg) Potentially toxic to children. Avoid it.
INDICATIONS• Erynorm plus tablets are indicated for the treatment of
hypertension in patients whose blood pressure can not be adequately controlled individually applied losartan or hydrochlorothiazide
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C09DA04 irbesartan+hidrohlorotiazid
Irbenida plus angiotensin II receptor antagonist, hydrochlorothiazide
Brand name INN
Irbenida plus Irbesartan, hydrochlorothiazide
ATC DDD Pregnancy
C09DA04 C(first trimester), D
Form and Package Lactation
f.c. tbl. 30x (150 mg+12,5 mg) f.c. tbl. 30x (300 mg+12,5 mg) Avoid
INDICATIONS• It is used in the treatment of essential hypertension.• This fixed combination is intended for adults whose blood
pressure is not adequately regulated using only irbesartan or hydrochlorothiazide only.
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C10 LIPID MODIFYING AGENTS (HYPOLIPEMICS)C10A LIPID MODIFYING AGENTS, PLAIN C10AA HMG CoA REDUCTASE INHIBITORS C10AA01 simvastatin
CholipamHypolipemic
Brand name INNCholipam simvastatin
ATC DDD Pregnancy C10AA01 O 0,015g X
Form and Package Lactation Film coated tablets 20 x 10mg film coated tablets 20 x 20mg
Avoid
INDICATIONSHyperlipidemia Type IIa, IIb and III•Coronary heart disease (primary and secondary •prevention).
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C10AA05 atorvastatin
Hipolip Hypolipemic
Brand name INNHipolip atorvastatin
ATC DDD Pregnancy C10AA05 O 20 mg X
Form and Package Lactation F.c. tablets 30 x 10 mg F.c. tablets 30 x 20 mgF.c. tablets 30 x 40 mgF.c. tablets 30 x 80 mg
Contraindicated. There are potentially serious adverse effects
INDICATIONSHypercholesterolemiaAtorvastatin is indicated as an adjunct to diet to reduce elevated total cholesterol, LDL-cholesterol, apolipoprotein B, and triglyceride levels in adults, adolescents and children older than
10 years with primary hypercholesterolemia, including family hypercholesterolemia (heterozygous form) and combined (mixed) hyperlipidaemia (corresponding types IIa and IIb according Fredrickson classification), when not achieved the desired response to diet and other non-pharmacological measures.In addition, atorvastatin is indicated for the reduction of elevated total cholesterol and LDL cholesterol in adults with homozygous familiar hypercholesterolemia, in addition to other lipid-lowering treatments (eg LDL apheresis) in situations where these treatments are not available.Prevention of cardiovascular diseasePrevention of cardiovascular events in adult patients who have a high estimated risk of first cardiovascular events, with correction of other risk factors.
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G GENITO URINARY SYSTEM AND SEX HORMONES (DRUGS FOR THE TREATMENT OF GENITO URINARY SYSTEM AND SEX HORMONES)G02 OTHER GYNECOLOGICALSG02A OXYOTOCICSG02AB ERGOT ALKALOIDSG02AB01 methylergometrine
MethylergometrineUterotonic
Brand name INNMethylergometrine methylergometrine
ATC DDD PregnancyG02AB01 O, P 0,0002g D
Form and Package Lactationdrops 10 ml ( 0,25 % mg/ ml )amp. 50 x 0,1 mg / 1 mlamp. 50 x 0,2 mg / 1ml
Avoid, possible inhibitory effect on prolactin secretion
INDICATIONSPostpartum and postabortion haemorrhage, •haemorrhage after cesarean section, menorrhage, metrorrhage, uterine atony.
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G04 UROLOGICALSG04BE Drugs used for erectile dysfunctionG04BE03 sildenafil
Sildena Drugs used in erectile dysfunction
Brand name INNSildena sildenafil
ATC DDD PregnancyG04BE03 O 50 mg X
Form and package Lactationfilm tablets 1 x 25 mgfilm tablets 1 x 50 mgfilm tablets 1 x 100 mg
Contraindicated
INDICATIONS• Treatment of erectile dysfunction, which is the inability
to achieve or maintain penile erection required for satisfactory sexual activity.
For the effect of sildenafil is required sexual stimulation
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G04C DRUGS USED IN BENIGN PROSTATIC HYPERTROPHYGO4CA ANTAGONISTS OF ALPHA-ADRENERGIC RECEPTORSG04CA02 tamsulosin
BetamsalTherapy of BPH
Brand name INNBetamsal tamsulosin
ATC DDD PregnancyG04CA02 O 0,4mg tamsulosin is solely
intended for use in men.
Form and package LactationHard caps. with modified release 30 x 0,4 mg tamsulosin is solely
intended for use in men.
INDICATIONS• Treatment of functional symptoms caused by benign
prostatic hyperplasia (BPH).
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G04CB TESTOSTERONE-5-ALPHA REDUCTASE INHIBITORSG04CB01 finasteride
Zerlonandrogen synthesis inhibitor
Brand name INNZerlon finasteride
ATC DDD Pregnancy G04CB01 O 0,005 g X
Form and Package LactationFilm coated tablets 30 x 5 mg Avoid
INDICATIONS• The treatment and control of benign prostatic hyperplasia
(BPH) in men with an enlarged prostate.
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H SYSTEMIC HORMONAL PREPARATIONS EXCLUDING SEX HORMONES AND INSULINESH02 CORTICOSTEROIDS FOR SYSTEMIC USEH02A CORTICOSTEROIDS FOR SYSTEMIC USE, PLAINH02AB GLUCOCORTICOIDSH02AB04 methylprednisolone
Lemod DepoCorticosteroid
Brand name INN
Lemod depo methylprednisolone
ATC DDD Pregnancy
H02AB04 O 0,0075 g; P 0,02 g B
Form and Package Lactation
inj. depot 10 x 1 ml/40 mgtablets 20 x 4 mgeff. tablets 20 x 16 mg
Caution
INDICATIONSRheumatoid arthritis and osteoarthritis•Bursitis, tendonitis, tenosynovitis, epicondylitis•Localized neurodermatitis, hypertrophic lichen planus, •necrobiosis lipoidica diabeticorum, lipoid necrosis, alopecia areata, systemic lupus erythematosus, acute and chronic contact dermatitis and systemic collagenosisBronchial asthma and allergic rhinitis •Acute exacerbations of multiple sclerosis•Leukemias and lymphomas•
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Lemod SoluCorticosteroid
Brand name INN
Lemod Solu methylprednisolone
ATC DDD Pregnancy
H02AB04 O 0,0075 g; P 0,02 g
B
Form and Package Lactation
inj. solu 15 x 20 mg with solvent inj. solu 15 x 40 mg with solvent inf. solu 1 x 125 mg with solvent inf. solu 1 x 500 mg with solvent
Caution
INDICATIONSSevere or incapacitating allergic conditions •Critical cardiovascular conditions (shock not responding to •standard treatment)Cerebral oedema, Tuberculous meningitis, acute •exacerbations of multiple sclerosisEndocrine and metabolic conditions (congenital adrenal •hyperplasia, nonsuppurative thyroiditis, hypercalcemia associated with cancer)Rheumatic diseases, collagen disorders and ulcerative •colitisRespiratory diseases (sarcoidosis, berylliosis, pulmonary •oedema, Loeffler’syndrome not manageable by other means).Leukemias and lymphomas•Cytostatic-induced nausea and vomiting •Acute severe exacerbations of lupus erythematosus, •exfoliative, contact dermatitis and generalized neurodermatitisOrgan transplant.•
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Lemod Solu – dabble-o-vialCorticosteroid
Brand name INNLemod Solu – dabble-o-vial methylprednisolone ATC DDD PregnancyH02AB04 O 0,0075 g; P 0,02 g BForm and Package Lactationlyophilisate for solution for injection with solvent for parenteral use, 40 mg lyophilisate for solution for injection with solvent for parenteral use, 125 mg
Caution
INDICATIONSLemod- Solu is indicated for the treatment of conditions when quick and intensive effect is needed, such as:
Allergic diseases and reactions - bronchial asthma, status •asthmaticus, angioneurotic oedema, anaphylaxis, serum sickness, atopic dermatitisRheumatic diseases - rheumatoid arthritis, posttraumatic •osteoarthritis, bursitis, tendovaginitis, epicondilitis, fibrositis, psoriatic arthritis and gout, ankylosing spondylitisCollagenoses - systemic lupus erythematosus, acute •rheumatic carditis, systemic dermatomiositis
Dermatologic diseases - pemphigus, exfoliative dermatitis, •bullous dermatitis herpetiformis, erythema multiforme, mycosis fungoides, severe forms of psoriasis and seborrheic dermatitisGastrointestinal diseases - ulcerative colitis, • Crohn’s diseaseRespiratory tract diseases - fulminant or disseminated •tuberculosis (with appropriate antituberculous therapy), symptomatic sarcoidosis, Loeffler’s syndrome, diffuse interstitial fibrosisNervous system diseases - acute exacerbations of multiple •sclerosisInflammatory eye diseases - Uveitis, diffuse scleritis, deep •parenchymatous keratitis, optic nerve neuritis, chorioretinitis, sympathetic ophthalmia, herpes zoster ophthalmicusLymphomas and leukemias - As a component of complex •therapeutic protocolsRenal diseases - Nephrotic syndrome without uremia, •idiopathic or in lupus erythematosus Cerebral oedema - After injury, operation or as a consequence •of brain tumorOrgan transplant - Transplant rejection reactions•
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J ANTIINFECTIVES FOR SYSTEMIC USEJ01 ANTIBACTERIALS FOR SYSTEMIC USE J01A TETRACYCLINESJ01AA TETRACYCLINESJ01AA02 doxycycline
DoksiciklinAntibiotic
Brand name INN
Doksiciklin doxycycline
ATC DDD Pregnancy
J01AA02 O 0,1g D
Form and Package Lactation
capsules 5 x 100 mg Avoid
INDICATIONSAcute and chronic gastrointestinal, respiratory and •urogenital tract, ENT and skin infections, caused by strains susceptible to doxycyclineRickettsial infections (typhus group, Q fever)•Chlamydial infections (limphogranuloma venerum, •nonspecific urethritis genitalne infections, pneumonia, trachoma, inclusion conjunctivitis)Infections due to borrelia (borreliosis, recurrent fever)•Infections due to mycoplasma (pneumonia, tularemia, •cholera)As an alternative drug in the treatment of gonorrhoea •and syphilis.
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J01C BETA LACTAM ANTIBACTERIALS, PENICILLINSJ01CA PENICILLINS WITH EXTENDED SPECTRUMJ01CA04 amoxicillin
Amoksicilinantibiotic
Brand name INNAmoksicilin amoxicillin
ATC DDD PregnancyJ01CA04 O 1 g B
Form and Package Lactationcapsules 16 x 250 mg capsules 16 x 500 mgpowder for syrup 100 ml (250 mg/5 ml)
Caution
INDICATIONSAmoxicillin is a broad spectrum antibiotic effect, which is used in the treatment of infections (caused by susceptible microorganisms) upper respiratory tract, oral cavity, pharynx, middle ear infections, lower respiratory tract, urinary tract infections (including gonorrhea), gastrointestinal tract (including Salmonella infection), Lyme disease in children, infection of the skin and soft tissue infections, endocarditis prophylaxis, eradication of Helicobacter pylori, as well as in the treatment of other infections caused by microorganisms sensitive to amoxicillin.
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J01CE BETA LACTAMASE SENSITIVE PENICILLINSJ01CE30 benzylpenicillin, procaine benzylpenicillin
Pancillinantibiotic
Brand name INN
Pancillin benzylpenicillin, procaine benzylpenicillin
ATC DDD Pregnancy
J01CE30 P 1,6 MIU B
Form and Package Lactation
lio vial 50 x 800 000 i.u. Avoid
INDICATIONSPANCILLIN is indicated for the prophylaxis and treatment of infections caused by organisms susceptible to penicillin.* Most commonly used for:
- Uncomplicated cases of pneumococcal pneumonia- Streptococcal infections (tonsillitis, scarlet fever, sinusitis)- diphtheria- gonorrhea- syphilis
For gonorrhea and syphilis cure only applies when the sensitivity of the pathogen was confirmed.* The prophylactic use before surgery on the head, neck, mouth and on the cardiovascular system.
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J01CR02 amoxicillin and clavulanic acid
PanklavAntibiotic
Brand name INNPanklav amoxicillin and clavulanic
acid
ATC DDD Pregnancy J01CR02 O 1 g B
Form and Package Lactation Film coated tablets 15 x (250+125) mg Film coated tablets 20 x (500+125) mg powder for oral susp. 100 ml (125+31,25) mg/5 mlpowder for oral susp. 100 ml (250+62,5) mg/5 ml
Caution
INDICATIONSPanklav used in the short-term treatment of bacterial infections in cases caused by bacteria that produce beta-lactamase and are resistant to amoxicillin. In other cases, to consider the application of amoxicillin.The combination of amoxicillin and clavulanic acid, beta-lactamase inhibition has expanded spectrum activity and is recommended in the treatment of:
Infections of the upper-respiratory tract infections (sinusitis, otitis media and recurrent tonsillitis). The most common causes of these infections are Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis and Streptococcus pyogenes.Infection of the lower respiratory tract (especially in cases of acute exacerbation of chronic bronchitis and bronchopneumonia). Common causes of these infections are Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis.
- Urogenital tract infections and abdomen, especially cystitis (recurrent or complicated, but excluding prostatitis), septic abortion, pelvic or puerperal sepsis and intraabdominal sepsis. Common causes of these infections were Enterobacteriaceae (mostly Escherichia coli), and Enterobacter species Staphylococcus saprophyticus.
- Infections of skin and soft tissue infections (particularly infections and cellulitis after bite animals and humans, as well as severe dental abscesses with cellulitis). Common causes of these infections are Staphylococcus aureus, Streptococcus pyogenes and Bacteroides species.
Mixed infections caused by organisms susceptible to amoxicillin, associated with microorganisms that produce beta-lactamase and who are sensitive to Panklav, can be treated with Panklav. In the treatment of such infections should not add some antibiotic resistant to beta-lactamase.
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J01CR02 amoxicillin and clavulanic acid
Panklav 2XAntibiotic
Brand name INN
Panklav 2X amoxicillin and clavulanic acid
ATC DDD Pregnancy
J01CR02 O 1 g B
Form and Package Lactation
Film coated tablets 14 x (875+125) mg powder for oral susp. 70 ml (400+57) mg/5 mlpowder for oral susp. 140 ml (400+57) mg/5 ml
Caution
INDICATIONSPanklav 2X is indicated for use in the treatment of infections in adults and children:• acute bacterial sinusitis (a certified diagnostic)• acute inflammation of the middle ear (otitis media)• acute exacerbation of chronic bronchitis (a certified diagnostic)• community acquired pneumonia• cystitis• pyelonephritis• infections of the skin and soft tissues, particularly cellulitis,
animal bites, severe dental abscess with spreading cellulitis• bone and joint infections, especially osteomyelitis.It is necessary to take into account official recommendations on the appropriate application of antibacterial drugs.
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J01D OTHER BETA LACTAM ANTIBACTERIALSJ01DA CEPHALOSPORINSJ01DA01 cefalexin
CefaleksinAntibiotic
Brand name INNCefaleksin cephalexin
ATC DDD PregnancyJ01DA01 O 2 g B
Form and Package Lactationcapsules 16 x 250 mg capsules 16 x 500 mg syrup 100 ml (250 mg/5 ml)
Caution
INDICATIONSCephalexin is indicated for the treatment of infections caused by susceptible bacteria:
Infections of the respiratory tract (tonsillitis, pharyngitis, •sinusitis, acute and chronic bronchitis, infections ofbronchiectasis)•Otitis media•Infections of the skin, soft tissues, bones and joints•Infections of genito-urinary tract (acute prostatitis, cystitis, •pyelonephritis)Infection in the oral cavity.•
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J01DC02 cefuroxime
Nilacef Antibiotic
Brand name INNNilacef cefuroxime NaATC DDD PregnancyJ01DC02 O 0,5 g; P 3 g BJKL Form and package Lactation03219710321972
inj. (powder for inj.) 1 x750 mginj. (powder for inj.) 1 x1500 mg Compatible
INDICATIONSCefuroxime is a bactericidal antibiotic of cephalosporin group, which is resistant to most β lactamases and is active in a broad spectrum of gram-positive and gram-negative microorganisms. It is used in the treatment of infections before identifying the cause, as well as infections caused by microorganisms sensitive to this antibiotic. In addition, effective in the prophylaxis of postoperative infections in many operations. Cefuroxime may be used as monotherapy or, if necessary, together with aminoglycosides and metronidazole, orally, parenterally or as a suppository.In the case of the presence or suspected presence of mixed aerobic and anaerobic infections (eg, peritonitis, aspiration pneumonia, abscesses of lung, pelvic or brain), or if it is likely to occur (eg colorectal or gynecological surgery) cefuroxime use in combination with metronidazole . Most of these infections will
respond to i.v. use of cefuroxime (750 mg) and metronidazole (500 mg per 100 ml) for eight hours. In severe mixed infections may be indicated intravenous cefuroxime in larger doses (1500 mg) and metronidazole (500 mg per 100 ml) for eight hours. In the prophylaxis of postoperative infections (eg colorectal or gynecological surgery) is indicated only a single dose of 1500 mg of cefuroxime and metronidazole (500 mg per 100 ml).If necessary, they can be given two doses of 750 mg of cefuroxime in combination with metronidazole.Indications include:• Respiratory infections (eg, acute and chronic bronchitis,
bronchiectasis associated with infection, bacterial pneumonia, lung abscess, postoperative chest infection)
• Infections of the ear, nose and throat (eg, sinusitis, tonsillitis, pharyngitis)
• Urinary tract infections (eg, acute and chronic pyelonephritis, cystitis, asymptomatic bacteriuria)
• soft tissue infections (eg, cellulitis, erysipelas, peritonitis and wound infections)
• bone and joint infections (eg, osteomyelitis, septic arthritis)• Gynaecological and obstetric infections (pelvic inflammatory
disease)• Gonorrhea (especially if they can not give penicillin)• Other infections, including septicemia and meningitis• Surgical prophylaxis (operations of abdomen, pelvis, heart and
blood vessels, lung, esophageal, orthopedic procedures, in which there is an increased risk of infection).
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J01DD02 ceftazidime
Forcas Antibiotic
Brand name INN
Forcas ceftazidime
ATC DDD Pregnancy
J01DD02 P 4 g B
JKL Form and package Lactation
03216000321601
inj. 1 x 1000 mginj. 1 x 500 mg Compatible
INDICATIONS Ceftazidime is indicated in the treatment of infections caused by a single cause, mixed infections caused by two or more susceptible microorganisms and, generally, in the treatment of serious infections, such as:
• Respiratory infections• Infections of the ear, nose and throat• Urinary tract infections• Infections of skin and soft tissue
• Gastrointestinal, biliary and abdominal infections• Infections of bones and joints• Dialysis: infections associated with hemodialysis,
peritoneal dialysis and continuous ambulatory peritoneal dialysis (CAPD).
In meningitis, before the ceftazidime monotherapy, to do antibiogram. Ceftazidime may be used in the treatment of infections with the pathogens resistant to other antibiotics, including aminoglycosides and many cephalosporins. If indicated, can be used in combination with aminoglycosides or other beta-lactam antibiotics, eg. with severe neutropenia or in combination with antianaerobe drugs if Bacteroides fragilis is suspected. Likewise, ceftazidime is indicated in perioperative prophylaxis in transurethral prostatectomy. In vitro combination of ceftazidime and aminoglycosides showed additive effect, and in some strains tested and synergy, which may be of importance in the treatment of patients with febrile neutropenia.
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J01DA1 ceftriaxone
AzaranAntibiotic
Brand name INN
Azaran ceftriaxone
ATC DDD Pregnancy
J01DA13 P 2 g B
Form and Package Lactation
powder for injections 50 x 1000 mg Caution
INDICATIONSCeftriaxone is indicated for the treatment of the following infections caused by susceptible microorganisms when parenteral therapy is required:• Pneumonia• Septicemia• Meningitis• Infections of the bones, skin and soft tissue• infections in patients with neutropenia• Perioperative prophylaxis of infections associated with surgical procedures.The treatment can be started before receiving confirmation of infectious agents.Adhere to the guidelines for the treatment of certain infections and appropriate antibiotic
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J01DE CEPHALOSPORINES IV GENERATIONJ01DE01 cefepim
CefimIV generation cephalosporine
Brand name INN
Cefim cefepim
ATC DDD Pregnancy
J01DE01 2 g P B
Form and Package Lactation
powder for injection or infusion 500 mgpowder for injection or infusion 1000 mg
Allowed
INDICATIONSCefim is used in the treatment of moderate to severe and severe infections caused by susceptible microorganisms. Here include:• Lower respiratory tract infections including pneumonia and
bronchitis• Uncomplicated and complicated urinary tract infections,
including pyelonephritis• Uncomplicated skin and soft tissue• Complicated intra-abdominal infections, including
peritonitis and biliary tract infections (in combination with metronidazole)
• Empirical therapy in patients with febrile neutropeniaCefim used to prevent infections in intra-abdominal surgery (in combination with metronidazole).
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J01F MACROLIDES, LINCOSAMIDES AND STREPTOGRAMINSJ01FA MACROLIDESJ01FA01 erythromycin
Eritromicin Antibiotic
Brand name INN
Eritromicin erythromicin-ethylsuccinate
ATC DDD Pregnancy
J01FA01 O, P 1 g; O 2 g B
Form and Package Lactation
Film coated tablets 20 x 250 mgFilm coated tablets 20 x 500 mg
Compatible
INDICATIONSTherapy and prophylaxis of infections caused by bacteria susceptible to erythromycin.
upper respiratory infections: tonsillitis, peritonsillar •abscess, pharyngitis, laryngitis, sinusitis, bacterial superinfection after influenza and the common cold.
lower respiratory tract infections: tracheitis, acute and •chronic bronchitis, pneumonia (lobular pneumonia, bronchopneumonia, primary atypical pneumonia), bronchiectasis, Legionnaire’s disease.Ear infections: otitis media and external otitis, mastoiditis.•Oral infections: gingivitis, Vincent angina.•Eye infection: blepharitis.•Skin and soft tissue: ulcers and carbunculus, paronichia, •abscesses, pustules, impetigo, cellulitis, erysipelas.Gastrointestinal infections: cholecystitis, staphylococcal •enterocolitis.Prophylaxis: pre-and post-operative trauma, burns, •rheumatic fever.Other infections: osteomyelitis, urethritis, gonorrhea, •syphilis, lymphogranuloma venerum, diphtheria, prostatitis, scarlet fever.
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J01FA MACROLIDESJO1FA09 clarithromycin
ZymbaktarAntibiotic
Brand name INNZymbaktar clarithromycin ATC DDD Pregnancy J01FA09 0,5 g O
1 g PC, Avoid unless no alternative present
Form and Package Lactation Film coated tablets 14 x 250 mgFilm coated tablets 14 x 500 mgGranules for oral susp. 125 mg/100 mlGranules for oral susp. 250 mg/100 ml
Excreted in breast milk. Avoid
INDICATIONSClarithromycin film-coated tablets are indicated in adults and children older than 12 years.Clarithromycin is indicated for the treatment of infections caused by susceptible micro-organisms. The indications include:Infection of the lower respiratory tract, eg acute and chronic bronchitis and pneumonia.-Infection of the upper respiratory tract, for example, sinusitis and pharyngitis.Clarithromycin is appropriate to begin therapy community acquired infections and it has been shown that in vitro active
against common and atypical respiratory pathogens.Clarithromycin is indicated for the treatment of mild to moderately severe infections of the skin and soft tissues.Clarithromycin is recommended, along with a suppressor of acid secretion omeprazole or lansoprazole in eradicating the bacteria H. pylori in patients with duodenal ulcer.In vitro activity of clarithromycin showed the following organisms:Gram-positive bacteria: Staphylococcus aureus (methicillin-susceptible), Streptococcus pyogenes (Group A beta hemolytic streptococcus), alpha hemolytic streptococci (viridans group); Streptococcus (diplococcus) pneumoniae; Streptococcus agalactiae; Listeria monocytogenes.Gram-negative bacteria: Haemophilus influenzae; Haemophilus parainfluenzae; Moraxella (Branhamella) catarrhalis; Neisseria gonorrhoeae; Legionella pneumophila; Bordetella pertussis; Helicobacter pylori Campylobacter jejuni.Mycoplasma: Mycoplasma pneumoniae; Ureaplasma urealyticum.Other organisms: Chlamydia trachomatis; Mycobacterium avium; Mycobacterium leprae.Anaerobes: Bacteroides fragilis sensitive to macrolides; Clostridium perfringens; Peptococcus species Peptostreptococcus species; Propionibacterium acnes.Clarithromycin is bactericidal against several bacterial strains. Among these organisms are Haemophilus influenzae; Streptococcus pneumoniae; Streptococcus pyogenes; Streptococcus agalactiae; Moraxella (Branhamella) catarrhalis; Neisseria gonorrhoeae; H. pylori and Campylobacter spp.Clarithromycin is more active against H. pylori under conditions of neutral pH than at acidic pH.
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J01FA10 azithromycin
HemomycinAntibiotic
Brand name INNHemomycin azithromycinATC DDD PregnancyJ01FA10 O 0,3 g BForm and package Lactationcapsules 6 x 250 mg powder for oral susp. 1 x 20 ml (200 mg/1 ml) film coated tablets 3 x 500 mg powder for oral susp. 1 x 20 ml (100 mg/5 ml)powder for oral susp. 1 x 30 ml (200 mg/5 ml)inf. 500 mg
Avoid
INDICATIONSAzithromycin is indicated for the treatment of infections caused by susceptible organisms:• Upper respiratory tract infections: sinusitis, pharyngitis /
tonsillitis (as an alternative first line therapy) lower respiratory tract infections: bacterial bronchitis, community acquired pneumonia, if appropriate oral therapy
• Acute otitis media• Uncomplicated skin and soft tissue (including erythema
migrans)• uncomplicated urethritis and cervicitis caused by Chlamydia
trachomatis• Genital ulcer (chancroid, ulcus molle) in men.
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J01FF LINCOSAMIDESJ01FF01 clindamycin
KlindamicinAntibiotic
Brand name INNKlindamicin clindamycin
ATC DDD PregnancyJ01FF01 O 1,2 g; P 1,8 g B
Form and package Lactationinj. 10 x 2 ml/(150 mg/1 ml) Compatible
INDICATIONSTreatment of serious infections caused by organisms sensitive to clindamycin.
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J01G AMINOGLYCOSIDE ANTIBACTERIALSJ01GB OTHER AMINOGLYCOSIDESJ01GB03 gentamicin
GentamicinAntibiotic
Brand name INN
Gentamicin gentamicin
ATC DDD Pregnancy
J01GB03 P 0,24 g D
Form and package Lactation
inj. 10 x 80 mg/2 mlinj. 10 x 120 mg/2 ml Caution
INDICATIONSUrinary tract infections (complicated and recidive)•Respiratory tract infections•Gastro-intestinal tract infections (including peritonitis)•Skin infections (including burns)•Soft tissue and bone infection•Septicemia (neonatal septicemia included)•Serious bacterial infections due to unknown cause•Mixed infections•
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J01M QUINOLONE ANTIBACTERIALSJ01MA FLUOROQUINOLONESJ01MA02 ciprofloxacin
MarocenAntibiotic
Brand name INNMarocen ciprofloxacinATC DDD PregnancyJ01MA02 O 1 g; P 0,5 g CForm and package LactationFilm coated tablets 10 x 250 mg film coated tablets 10 x 500 mg inj. 5 x 100 mg/10 ml
Avoid
INDICATIONSCiprofloxacin is indicated for the treatment of the following infections caused by susceptible bacteria. Before initiation of therapy with ciprofloxacin should take into account available information on resistance to ciprofloxacin.Adults• Infections of the lower respiratory tract caused by gram-
negative bacteria: exacerbation of chronic obstructive pulmonary disease; broncho-pulmonary infections in cystic fibrosis and bronchiectasis; pneumonia
• Chronic suppurating otitis media• Acute exacerbation of chronic sinusitis especially if it is caused
by gram-negative bacteria
• Urinary tract Infections• Gonococcal urethritis and cervicitis• epididymis-orchitis including cases caused by the Neisseria
gonorrhoeae• Pelvic inflammatory disease, including those caused by the
Neisseria gonorrhoeaeInfections of the genital organs that are thought or known to be caused by the Neisseria gonorrhoeae is very important to take into account the local prevalence of resistance to ciprofloxacin and to confirm susceptibility with appropriate microbiological tests.• Gastrointestinal infections (eg traveler’s diarrhea)• Intra-abdominal infections• Infections of the skin and soft tissue caused by Gram-negative
bacteria• Necrotizing (malignant) otitis externa• Infections of bones and joints• Treatment of infections in patients with neutropenia• Prophylaxis of infections in patients with neutropenia• Prophylaxis of invasive infections due to Neisseria meningitidis• Pulmonary anthrax (after exposure prophylaxis and therapy)Children and adolescents• Bronchopulmonary infections in cystic fibrosis caused by
Pseudomonas aeruginosa • Complicated urinary tract infections and pyelonephritis• Pulmonary anthrax (after exposure prophylaxis and therapy)If it is deemed necessary, ciprofloxacin can be used to treat severe infections in children and adolescents.Treatment can start a physician experienced in the treatment of cystic fibrosis and / or severe infections in children and adolescents.
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J01MA12 levofloxacin
Forteca Antibiotic
Brand name INN
Forteca levofloxacin hemihydrate
ATC DDD Pregnancy
J01MA12 0,5 g O C
Form and package Lactation
film tablets 10 x 250 mgfilm tablets 10 x 500 mg
Avoided, it excreted in milk
INDICATIONS Levofloxacin is indicated for the treatment of adult patients with mild to moderate infections caused by susceptible bacteria:• Acute bacterial sinusitis (adequately diagnosed according
to national and /or local guidelines for the treatment of respiratory infections)
• Acute bacterial exacerbation of chronic bronchitis (adequately diagnosed according to national and /or local guidelines for the treatment of respiratory infections)
•community acquired pneumonia•uncomplicated urinary tract infections•Complicated urinary tract infections, including pyelonephritis•Chronic bacterial prostatitis•Infections of skin and soft tissueBefore prescribing levofloxacin to take into account the recommendations of national and /or local guides on the appropriate application of fluoroquinolones.
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J01MB OTHER QUINOLONESJ01MB04 pipemidic acid
PipemUroantiseptic
Brand name INN
Pipem pipemidic acid
ATC DDD Pregnancy
J01MB04 O 0,8 g No data available
Form and package Lactation
capsules 20 x 200 mg Avoid
INDICATIONSPipemidic acid is a urinary antiseptic used for the treatment of infections caused by microorganisms sensitive to pipemidic acid:• Acute and chronic infections of the lower urinary tract,• Prevention of recurrent lower urinary tract infection,• Vaginal infections
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J01X OTHER ANTIBACTERIALSJ01XX OTHER ANTIBACTERIALSJ01XX08 linezolid
ZenixAntibiotic
Brand name INN
Zenix linezolid
ATC DDD Pregnancy
J01XX08 O, P 1,2 g C. No data available
Form and package Lactation
tablets 10 x 600 mginf. solution 10 x 600 mg
CautionNo data available
INDICATIONSZenix is indicated in treatment of the following infections caused by susceptible gram-positive bacteria:
Nosocomial pneumonia•Community-acquired pneumonia •
Complicated skin and skin structure infections. •Linezolid is to be used only if it is proven or suspected that infection is due to gram-positive bacteria. In patients with infection due to gram-positive and gram-negative bacteria, linezolid can be used only when other therapeutic methods are not available and in combination with drugs for gram-negative bacteria.
Before starting treatment with Zenix it is necessary to have information about gram-positive bacteria resistance to antibacterial drugs or to do antibiogram. Linezolid does not effect gram-negative bacteria. If it is proven or suspected that infection is due to gram-positive bacteria as well as gram-negative bacteria, combined treatment with antibacterials that effect gram-negative bacteria is necessary.
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Brand name INNFluconal fluconazoleATC DDD PregnancyJ02AC01 O, P 0,2 g CForm and package Lactationcapsules 7x50mgcapsules 1x150mg
Excretion in breast milk. It can be used during lactation period only in children with disseminated candidiasis
INDICATIONSFluconal is indicated for the treatment of the following conditions:•Genital candidiasis. Vaginal candidiasis, acute or recurrent.
Candida balanitis. It is necessary to consider the treatment of partners.
•Mucosal candidiasis (oropharyngeal and oesophageal candidiasis, non-invasive bronchopulmonary infections,
Candiduria, mucocutaneous candidiasis and chronic atrophic oral candidiasis (oral thrush). The persons with normal immune systems can be treated, and immunocompromised patients also.
•Dermatomycosis including tinea pedis, tinea corporis, tinea cruris, tinea versicolor and dermal candidiasis only in those states where there is resistance to first-line therapy or if this infections occur in immunocompromised patients.
•Systemic candidiasis including candidaemia, disseminated candidiasis and other forms of invasive Candida infections. This refers to the infection of peritoneum, endocardium, lungs and urinary tract. The safest and Candida infections in patients with malignancy, in patients in intensive care, as well as in patients receiving cytotoxic or immunosuppressive therapy.
•cryptococcal infections, including cryptococcal meningitis and infections of other sites (eg, lung, skin). With Fluconal can treat people with normal immune systems, patients with AIDS, organ transplants and immunosuppresion of other origin. Fluconal can be used as maintenance therapy for relapse prevention of cryptococcal infection in patients with AIDS.
•Prevention of fungal infections in patients with immunodeficiency, who are at risk of neutropenia after cytotoxic chemotherapy or radiation therapy, including patients with bone marrow transplantation.
J02 ANTIMYCOTICS FOR SYSTEMIC USEJ02A ANTIMYCOTICS FOR SYSTEMIC USEJ02AC TRIAZOLE DERIVATIVESJ02AC01 fluconazole
FluconalAntimycotic
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Fluconalantimycotic for systemic use
Brand name INNFluconal fluconazole
ATC DDD PregnancyJ02AC01 O, P 0,2 g C
Form and package Lactationinf. solution 2 mg/ml 100 ml Excretion in breast milk. It can be used
during lactation period only in children with disseminated candidiasis
INDICATIONSFluconazole is indicated in adults for the treatment of:• cryptococcal meningitis.• coccidioidomycosis.• Invasive candidiasis• mucosal candidiasis, including oropharyngeal, esophageal
candidiasis, candiduria and chronic mucocutaneous candidiasis.
• Chronic atrophic oral candidiasis (with the use of dentures) if oral hygiene and topical therapy does not demonstrate efficacy.
Fluconazole is indicated in adults for the prophylaxis of:• The reappearance of cryptococcal meningitis in patients at high
risk of recurrence.
• Repeated occurrence of oropharyngeal or esopharyngeal candidiasis in patients infected with HIV who are at high risk for relapse.
• Prophylaxis of Candida infections in patients with prolonged neutropenia (such as patients with hematological malignancies who are undergoing chemotherapy or patients who have had a transplant of hematopoietic stem cells.
Fluconazole is indicated in term neonates, infants, children and adolescents under the age of 17 years:Fluconazole is used to treat mucosal candidiasis (oropharyngeal, esophageal), invasive candidiasis, cryptococcal meningitis and prophylaxis of Candida infections in immunocompromised patients.Fluconazole can be used as a preventive therapy of cryptococcal meningitis in children with high risk of recurrence.Therapy can be started before the results of cultures and other laboratory analysis to be known, but, once these results become available, anti-infective therapy should be adjusted to the results obtained.Should be considered official guidance on the appropriate use of antifungal drugs.
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L ANTINEOPLASTIC AND IMMUNOMODULATING AGENTSL01CD02 docetaxel
Docetaxel HFAntineoplastic
Brand name INNDocetaxel HF docetaxel
ATC DDD PregnancyL01CD02 D
Form and Package LactationConcentrate and solvent for solution infusion, 20 mg/0,5 mlConcentrate and solvent for solution infusion, 80 mg/2 ml
Breastfeeding is not recommended
INDICATIONSBreast cancerDocetaxel in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with operable node positive breast cancer.Docetaxel in combination with doxorubicin is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have not previously received treatment with cytotoxic drugs to treat this disease.Docetaxel as a single agent, is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of prior cytotoxic therapy applied. Previous chemotherapy should include anthracycline or alkylation agent.
Docetaxel in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumors over-express HER2, who had not previously received chemotherapy for metastatic disease.Docetaxel in combination with capecitabine, is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should include anthracycline.Non-small cell lung cancerDocetaxel is indicated for the treatment of patients with locally advanced or metastatic non small cell lung cancer after failure of prior chemotherapy.In combination with cisplatin, docetaxel is indicated for the treatment of patients with unresectable, locally advanced or metastatic non-small cell lung cancer, in patients who have not previously received chemotherapy for this disease.Prostate CancerDocetaxel in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone-refractory metastatic prostate cancer.Adenocarcinoma of the stomachDocetaxel in combination with cisplatin and 5-fluorouracil is indicated for the treatment of patients with metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal coupling, which had not previously received chemotherapy for metastatic disease.Head and neck cancersDocetaxel, in combination with cisplatin and 5-fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck.
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L01XA03 oxaliplatin
Oxaliplatin HFAntineoplastic
Brand name INNOxaliplatin HF oxaliplatin
ATC DDD PregnancyL01XA03 D
Form and package LactationPowder for solution infusion 50 mg Powder for solution infusion 100 mg
Contraindicated
INDICATIONS Oxaliplatin in combination with 5-fluorouracil (5-FU) and folinic acid (FA) is indicated for:- Adjuvant treatment of colorectal cancer in clinical stage III
(Duke’s C) after radical surgery;- Treatment of metastatic colorectal cancer.
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L02AB01 megestrol acetate
O’TentikaProgestagen
Brand name INNO’Tentika megestrol acetate
ATC DDD PregnancyL02AB01 0,16 g O C
Form and package Lactationoral suspension 40 mg/ml, 240 ml Avoided
INDICATIONS O’Tentika used to treat anorexia or weight loss that is caused by malignant disease (cachexia), or acquired immunodeficiency syndrome (AIDS) patients of both sexes.
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L02BG03 anastrozole
AltravesaSelective aromatase inhibitor
Brand name INNAltravesa anastrozole
ATC DDD PregnancyL02BG03 O 1 mg X
Form and package LactationF.c.-tbl. 28 x 1 mg Contraindicated
INDICATIONS• Treatment of hormone receptor-positive advanced breast
cancer in postmenopausal women
• Adjuvant therapy of hormone receptor-positive early invasive breast cancer in postmenopausal women
• Adjuvant treatment of early invasive hormone receptor positive breast cancer in postmenopausal women who received adjuvant tamoxifen therapy 2 to 3 years
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M MUSCULO-SKELETAL SYSTEMM01 ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTSM01A ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS, NON-STEROIDSM01AB ACETIC ACID DERIVATIVES AND RELATED SUBSTANCESM01AB05 diclofenac
DiclofenacRapten DuoRapten Knon-steroid antiinflammatory drug, analgesic
Brand name INNDiclofenac Rapten DuoRapten K
diclofenac sodium
diclofenac potassiumATC DDD PregnancyM01AB05 O,P,R 0,1 g C (D in 3rd trimester and in time of
baby delivery)Form and package LactationFilm coated tablets 30 x 50 mgretard tablets 20 x 100 mginj. 5 x 75 mg / 3 mlsupp. 10 x 25 mgsupp. 10 x 50 mgtablets 30 x 75 mgdragee 10 x 50 mg
Caution
INDICATIONSInflammatory and degenerative articular and •extraarticular rheumatism (rheumatoid arthritis, osteorthritis, juvenile rheumatoid arthritis, ankylosing spondylitis, arthrosis and spondiloarthrosis, spondylosis, periarthritis, tendovaginitis, fibrositis, myositis)
Primary dysmenorrhea•
Acute uric arthritis•
Renal and biliar colic (parenteral use)•
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ZodolNSAID, analgesic
Brand name INN
Zodol ketorolac
ATC DDD Pregnancy
M01AB15 O, P 0,03 g C (D in 3rd trimester)
Form and package Lactation
F.c.-tbl. 10 x10 mginj..5x30 mg/ml Avoid
INDICATIONSZodol is indicated for short-term treatment of moderate and severe acute pain and may replace opioid analgesics (postoperative pain, renal colic, orthopedic trauma, cancer related pain).
Ketorolac is not used for the treatment of chronic pain conditions.
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M04 ANTIGOUT PREPARATIONSM04A ANTIGOUT PREPARATIONSM04AA PREPARATIONS INHIBITING URIC ACID PRODUCTIONM04AA01 allopurinol
Alopurinolantiuric (uricostatic)
Brand name INN
Alopurinol allopurinol
ATC DDD Pregnancy
M04AA01 O, P 0,4 g C
Form and package Lactation
tablets 40 x 100 mg Avoid
INDICATIONSAllopurinol is used for the reduction of the urate and uric acid •in states that already have deposits of urate and uric acid (gout, nephrolithiasis), or there is the risk of these deposits (malignancy therapy that could potentially cause acute uricosuric nephropathy).
Clinical conditions which may give rise to the formation •of deposits of urate and uric acid are idiopathic gout, urolithiasis, acute uricosuric nephropathy, neoplasms and myeloproliferative diseases with intense cellular metabolic turnover, in which high levels of uric acid occur spontaneously or after cytotoxic therapy, certain enzyme disorders lead to increased production of uric acid (a disorder hypoxanthine-guanine phosphoribosiltransferase, including Lesch-Nyhan syndrome, a disorder of glucose-6-phosphatase involvement of the accumulation of glycogen synthase phosphoribosilpyrophosphate disorder, disorder phosphoribosilpyrophosphate amidotransferase, adenine phosphoribosiltransferase disorder).Allopurinol is used to treat 2,8-dihydroxiadenine (2,8-•DHA) renal calculi due to decreased activity of adenine phosphoribosiltransferase.Allopurinol is used to treat re-mixed oxalate renal calculi in the •presence of hyperuricosuria in cases where diet, increased fluid intake, and similar measures have no effect.
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M05BA04 alendronic acid (in form of sodium salt)
BonapBisphosphonate
Brand name INNBonap Alendronic acid
ATC DDD PregnancyM05BA04 10 mg O C
JKL Form and package Lactation1059079 tablets 4 x 70 mg Avoided
INDICATIONS• Post-menopausal osteoporosis (alendronate reduces the
risk of vertebral and hip fractures).
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N NERVOUS SYSTEMN02 ANALGESICSN02A OPIOIDSN02AX OTHER OPIOIDSN02AX02 tramadol
Trodonopioid analgesic
Brand name INNTrodon tramadol ATC DDD PregnancyN02AX02 O,P 0,3g CForm and package Lactationcapsules 20 x 50 mginjections 5 x 50 mg/ mlinjections 5 x 100 mg/ 2 mlfilm coated retard tablets 10 x 100 mgfilm coated retard tablets 10 x 200 mg
Avoid
INDICATIONSTreatment of moderate to severe pain.
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N02CC03 zolmitriptan
Zolmitriptan anti-migraine drug
Trade mark INNZolmitriptan zolmitriptanATC DDD PregnancyN02CC03 O, 2,5 mg CForm and package LactationOral dispersible tablets 3 x 2,5 mgOral dispersible tablets 6 x 5 mg Caution
INDICATIONSZolmitriptan is indicated for acute treatment of migrain with or without aura.
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N03 ANTIEPILEPTICSN03A ANTIEPILEPTICS
Eftil Eftil retardantiepileptic
Brand name INN
EftilEftil retard
Valproic acid + sodium valproate
ATC DDD Pregnancy
N03AG01 O, P, R 1,5 g D
Form and package Lactationsyrup 150 ml/5,764 gretard film tablets 30 x(145 + 333) mg
Caution
INDICATIONSEftil retard is used in children and adults as monotherapy or in combination with other antiepileptic drugs in the treatment of:
• Generalized seizures: clonic and tonic seizures, tonic-clonic seizures (grand mal epilepsy), absence seizures (petit mal seizures) and myoclonic seizures or atonic and Lennox-Gastaut syndrome.
• Partial epilepsy: partial seizures with or without secondary generalization.
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N03AX09 lamotrigin
Solaban Antiepileptic
Brand name INNSolaban LamotriginATC DDD PregnancyN03AX09 O 0,3 g C -All antiepileptic drugs
are teratogenic but the benefit of application is greater than the risk for the fetus.
Form and package LactationTablets for oral suspen. 30 x 5 mgTablets for oral suspen. 30 x 25 mgTablets for oral suspen. 30 x 50 mgTablets for oral suspen. 30 x 100 mg
Present in milk, potentially toxic to children, avoiding breastfeeding
INDICATIONSLamotrigine is indicated in the treatment of:
1) epilepsy:Adults and adolescents:
• In the monotherapy epilepsy: partial seizures and generalized seizures (attacks the primary and secondary tonic-clonic seizures)
• As a complementary therapy of epilepsy: partial seizures, generalized seizures (attacks the primary and secondary tonic-clonic seizures) and seizures in the Lennox-Gastaut syndrome in case of failure of treatment with other antiepileptic drugs.
Children older than 2 years:• As a complementary therapy of epilepsy: partial
seizures and seizures in the Lennox-Gastaut syndrome.
2) Bipolar affective disorder:Adults (over 18)
• The prevention of depressive episodes in patients with bipolar affective disorder.
Suggested use: For the treatment administered by a neurologist, pediatric neurologist or a psychiatrist or physician who knows the treatment of epilepsy and is especially qualified to treat the mentally handicapped patients, the treatment in the department of neurology, psychiatry and mental disorders.
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N04 ANTI-PARKINSON DRUGSNO4BC DOPAMINE AGONISTS NO4BC05 pramipexole
Panarak Antiparkinsonic
Brand name INN
Panarak pramipexole
ATC DDD Pregnancy
N04BC05 O, 2,5 mg C
Form and package Lactation
30 tablets x 0,18 mg30 tablets x 0,7 mg Avoided
INDICATIONSPramipexol is indicated in adults for the treatment of signs and symptoms of idiopathic Parkinson’s disease as monotherapy (without levodopa) or in combination with levodopa, ie. throughout the period of the disease until the late stages when the effect of levodopa begins to deteriorate or become unstable, leading to fluctuations of the therapeutic effect (“end of dose” phenomenon or “on-off” fluctuations). Pramipexol is indicated in adults for the symptomatic treatment of moderate to severe idiopathic restless legs syndrome in doses of less than 0.54 mg pramipexol base (0.75 mg pramipexol salt)
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N05 PSYCHOLEPTICSN05AH DIAZEPINS, OXAZEPINS AND THIAZEPINSN05AH03 olanzapine
TreanaAntipsychotic
Brand name INNTreana olanzapine
ATC DDD PregnancyN05AH03 O, P 10 mg C – Studies have shown
toxic effects on the fetus
Form and package LactationFilm tablets 30 x 5 mgFilm tablets 30 x 10 mg
Avoided, it excreted in milk
INDICATIONSOlanzapine is primarily used to treat schizophrenia. In patients who achieved a good initial response to therapy, olanzapine has proven effective in maintenance therapy and control of symptoms of schizophrenia. Olanzapine is also indicated in the treatment of moderate to severe episodes of mania. In patients with bipolar disorder who have shown good initial response to therapy, during manic episodes, olanzapine is used to prevent recurrence of manic phase of illness.
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NO5AX OTHER ANTIPSYHOTICSN05AX08 risperidone
Risperidon Antipsychotic
Brand name INNRisperidon risperidonATC DDD PregnancyN05AX08 O 5 mg C – applied only if the potential
benefit outweighs the riskForm and package Lactationfilm tablets 20 x 1 mg film tablets 20 x 2 mgfilm tablets 20 x 3 mgfilm tablets 20 x 4 mg
avoid it, no reliable data
INDICATIONSRisperidone is indicated for the treatment of a wide spectrum of patients with schizophrenia, including the first episode psychoses, acute schizophrenic exacerbations, chronic schizophrenia and other psychotic states with prominent positive symptoms (such as hallucinations, delusions, thought disorders, hostility, suspiciousness) and / or negative symptoms (indifference, emotional and social withdrawal, the scarcity of speech). Risperidone also facilitates and affective symptoms associated with schizophrenia (depression, guilt, anxiety).
Risperidone is effective for maintenance therapy in patients who have responded to the initial use of risperidone.Risperidone-monotherapy is indicated for the short treatment of manic or mixed episodes associated with bipolar disorder. Combination therapy-concomitant use with lithium or valproic acid is indicated for the short treatment of manic or mixed episodes associated with bipolar disorder, manifesting itself as elevated mood, euphoric or irritable, agitation, grandiosity, exaggerated self-esteem, decreased need for sleep, rapid speech, accelerated thoughts, reduced attention or judgment, including highly active or hostile behavior.Risperidone is indicated for the treatment of severe behavioral disorders in patients with dementia, such as aggressiveness (the verbal performances, as well as in psychiatric manifestations), disturbances of body movement (agitation, movements without goal) or psychotic symptoms that lead patients to a state of suffering, uncertainty themselves and the potential dangers of self-harm. Such patients should be monitored carefully and use the drug Risperidone continue only if the benefit is greater than the risk to the patient. Risperidone is also indicated as an adjuvant therapy to mood stabilizers in treating acute manic episodes in bipolar disorder. Risperidone is indicated in the treatment disruptive behavioral disorders in adults with limited social, academic and work functioning, and which are expressed in behavioral disorders such as aggressiveness, impulsiveness and self-mutilation.
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N05B ANXIOLYTICSN05BA BENZODIAZEPINE DERIVATIVESN05BA01 diazepam
DiazepamAnxiolytic
Brand name INNDiazepam diazepam
ATC DDD PregnancyN05BA01 O 0,01 g D
Form and package Lactationtablets 30 x 2 mgtablets 30 x 5 mgtablets 30 x 10 mg
Avoid
INDICATIONSAnxiety states (endogenous or general anxiety due to social •conflicts).Insomnia due to anxiety (benzodiazepines are indicated •for the treatment of insomnia only in severe cases when the condition interferes with normal functioning and performance of daily activities).acute alcohol abstinence syndrome.•Preparation for endoscopic examination and surgical •procedures.muscle spasms (including spasms in cerebral spasticity) •and the treatment of epilepsy.Night fears and somnambulism in children.•
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N05BA06 lorazepam
LorazepamAnxiolytic
Brand name INNLorazepam lorazepam
ATC DDD PregnancyN05BA06 O 0,0025 g D
Form and package Lactationtablets 30 x 1 mgtablets 20 x 2,5 mg Avoid
INDICATIONSLorazepam is indicated:
for short-term treatment of anxiety conditions that •lead to disability, including anxiety associated with psychosomatic, organic or psychotic illness
for short-term treatment of insomnia (sleeplessness) •associated with anxiety
in premedication before surgery or more extensive •dental procedures
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N05BA08 bromazepam
BromazepamAnxiolytic
Brand name INNBromazepam bromazepam
ATC DDD PregnancyN05BA08 O 0,01 g D
Form and package Lactationtablets 30 x 1,5 mgtablets 30 x 3 mgtablets 30 x 6 mg
Avoid
INDICATIONSTreatment of anxiety. The drug is designed to treat •serious disorders that interfere with their daily activities and create serious problems for the patient.
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N05BA11 prazepam
Demetrin Anxiolytic
Brand name INNDemetrin prazepam
ATC DDD PregnancyN05BA11 O 0,03 g D
Form and package Lactationtablets 20 x 10 mg Avoid
INDICATIONS
Prazepam is indicated in the treatment of anxiety •disorders
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N05C HYPNOTICS AND SEDATIVESN05CF02 zolpidem
Belbien Short-acting hypnotic
Brand name INNBelbien zolpidem
ATC DDD PregnancyN05CF02 10 mg O B-applied only if necessary
Form and package Lactationfilm tablets 20 x 10 mg low concentrations present
in milk, avoid it
INDICATIONSShort-term treatment of insomnia.•Benzodiazepines and related drugs benzodiazepines •are indicated only for severe disorders that deplete or incapacitate the patient
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N06AB SELECTIVE SEROTONIN REUPTAKE INHIBITORSN06AB03 fluoxetine
FlunisanAntidepressive
Brand name INNFlunisan fluoxetine
ATC DDD PregnancyN06AB03 O 0,02 g B
Form and package Lactationtablets 30 x 20 mg Avoid
INDICATIONSAdults•Major depressive episodes•Obsessive Compulsive Disorders•Bulimia nervosa: Flunisan is indicated as a supplement to •psychotherapy to reduce food intake and increased bowel movements.Children and adolescents aged 8 and over•Moderate to severe, major depressive episode, if •there is no improvement after 4-6 sessions depression psychotherapy. Antidepressant therapy in children and young adults with moderate and severe depression should always be combined with psychosocial therapy.
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N06AB06 sertraline
Sidata Antidepressive
Brand name INNSidata sertraline
ATC DDD PregnancyN06AB06 O 50 mg X
Form and package LactationFilm coated tablets 28 x 50 mg Film coated tablets 28 x 100 mg
contraindicated
INDICATIONSThe use of SIDATA film-coated tablet is indicated in the following cases:
• treatment of symptoms of depression, including depression accompanied by anxiety symptoms. After a satisfactory therapeutic response, continuation sertraline treatment efficiency is achieved in the
prevention of initial episodes of depression relapse or re-occurrence of depressive episodes, including the associated symptoms of anxiety.
• treatment of obsessive compulsive disorder. After a satisfactory therapeutic response, efficiency, safety and tolerability of sertraline application is held up to 2 years of therapy for this disorder.
• treatment of panic disorder, with or without agoraphobia.
• treatment of social phobia. Upon satisfactory treatment response, continuation with sertraline therapy achieves efficiency in preventing relapse of initial episodes of social phobia.
• treatment of post-traumatic stress syndrome.• treatment of obsessive compulsive disorder in children
older than 6 years.
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N06AB10 escitalopram
Lata Antidepressive
Brand name INNLata escitalopram
ATC DDD PregnancyN06AB10 O, 10 mg C
Form and package Lactationfilm tablets 28 x10 mg Excreted in milk, avoid it
INDICATIONSEscitalopram is used to treat: • major depressive episodes • panic disorder with or without agoraphobia • Social phobia • Obsessive-Compulsive Disorder
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N06D DRUGS FOR DEMENTION THERAPYN06DA ANTICHOLINERGICSN06DA02 donepezil chloride
Tregona Drug for demention therapy
Brand name INNTregona donepezil
ATC DDD PregnancyN06DA02 O 7,5 mg C-Studies have shown toxic
effects on the fetus
Form and package Lactation
film tablets 28 x 5 mgfilm tablets 28 x 10 mg
Avoid
INDIKACIJESymptomatic treatment of mild to moderate dementia •of the Alzheimer type.
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N07 OTHER NERVOUS SYSTEM DRUGSN07B DRUGS USED IN ADDICTION DISORDERSN07BC DRUGS USED IN OPIOID DEPENDENCEN07BC02 methadone
Metadonsynthetic narcotic analgesic
Brand name INNMetadon methadone
ATC DDD PregnancyN07BC02 O, P 0,025 g C
Form and package Lactationdrops 1 x 10 ml (10 mg/ ml) Caution
INDICATIONSMethadone is used to treat opiate addiction, as a •means of preventing the appearance of abstinence syndrome.
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R RESPIRATORY SYSTEMR DRUGS FOR TRETAMENT OF RESPIRATORY DISEASESR03 drugs used in obstructive lung diseaseR03AC12 salmeterole xinafoate
Serevent Inhaler CFC-Free Antiasthmatic
Brand name INNSerevent Inhaler CFC-Free salmeterole xinafoate
ATC DDD PregnancyR03AC12 O 100 mcg C
Form and package Lactationinhaler with a pressurized dispenser, 120x25 µg/dose
No data
INDICATIONSRegular additional symptomatic treatment of reversible •airways obstruction in patients with asthma, including patients with nighttime symptoms, which are not adequately controlled with inhaled corticosteroids in accordance with current therapeutic guides.Serevent Inhaler CFC-Free is used in the treatment of •chronic obstructive pulmonary disease (COPD) in the prevention of exercise-induced asthma attacks.
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R03B Other drugs used in obstructive lung disease, for inhalationR03BA GlucocorticoidsR03BA01 beclomethasone dipropionate
Becloforte CFC-Free Inhalerantiasthmatic
Brand name INNBecloforte CFC-Free Inhaler beclomethasone dipropionateATC DDD PregnancyR03BA01 800 mcg CForm and package Lactationinhaler with a pressurized dispens-er, 1 x 200 dose (250 µg/1 dose)
No data
INDICATIONSSevere asthma is a disease that can be fatal and requires regular medical monitoring. Patients with severe asthma have constant symptoms and frequent exacerbations, with limited lung capacity and values of peak expiratory flow (PEF), less than 60% predicted baseline values with a variation greater than 30%, often do not return to normal after the use of bronchodilators. These patients required high doses of inhaled or oral corticosteroid therapy. Sudden worsening of symptoms may require increased doses of corticosteroids should be given under medical supervision.
AdultsProphylaxis in:• Mild asthma (PEF values above 80% predicted baseline
values, with variations of less than 20%) patients who occasionally require symptomatic treatment of asthma with bronchodilators.
• Moderate asthma (PEF values 60-80% predicted basal values, ranging from 20-30%) patients who require regular use of drugs to treat asthma and patients with unstable asthma is getting worse despite the implementation of prophylactic therapy or bronchodilator alone.
• Asthma (PEF values below 60% predicted baseline values, with variations of more than 30%) patients with severe chronic asthma.
ChildrenAll children that are needed drugs for the prevention of asthma.
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R03BA05 fluticasone propionate
Flixotide antiasthmatic
Brand name INN
Flixotide fluticasone propionate
ATC DDD Pregnancy
R03BA05 0,6 mg C
Form and package Lactation
suspension for inhalation under pressure;50 mcg/dose; pressurized container, 1x120 dosesuspension for inhalation under pressure; 125 mcg/ dose; pressurized container, 1x60 dosesuspension for inhalation under pressure; 250 mcg/ dose; pressurized container, 1x60 dose
No data
INDICATIONSFluticasone propionate applied with inhalation provides prophylactic treatment of asthma.Adults:Mild asthma: patients who on a regular daily basis require intermittent bronchodilation therapy.Moderately severe asthma: patients with unstable asthma or asthma that worsens despite application prophylactic therapy or bronchodilator alone.Severe asthma: Patients with severe chronic asthma and those who are dependent on systemic corticosteroids applied to adequately control symptoms. Upon the introduction of fluticasone propionate inhalation, many of these patients can significantly reduce or eliminate the need for oral corticosteroids.
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R06 ANTIHISTAMINES FOR SYSTEMIC USER06A ANTIHISTAMINES FOR SYSTEMIC USER06AX OTHER ANTIHISTAMINES FOR SYSTEMIC USER06AX13 loratadine
Pressingnon-sedating antihistamines
Brand name INNPressing loratadine
ATC DDD PregnancyR06AX13 O 0,01 g B
Form and package Lactationeff. tablets 10 x 10 mgtablets 10 x 10 mg syrup 1 x 120 ml (5 mg/5 ml)
Caution with higher doses
INDICATIONSSeasonal allergic rhinits•Allergic conjunctivitis•Non-seasonal chronic idiopatic rhinits •Chronic urticaria and other allergic dermatosis•Additional therapy in treatment of bronchial asthma•
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S SENSORY ORGANSS01 OPHTHALMOLOGICALSS01A ANTIINFECTIVESS01AA ANTIBIOTICSS01AA01 chloramphenicol
HloramkolAntibiotic
Brand name INNHloramkol chloramphenicol
ATC DDD PregnancyS01AA01 C
Form and package Lactationeye ointment 1 x 5 g 1 %0,5% eye drops, solution
Caution
INDICATIONSHloramkol eye ointment 1% is used for the treatment of anterior segment of eye infections (caused by bacteria that are sensitive to chloramphenicol, when other antibiotics have no effect or are contraindicated), such as:• blepharitis and blepharoconjunctivitis• Bacterial conjunctivitis• Bacterial keratitis• expository, neuroparalitic and neurotrophic keratitis in the case of secondary bacterial infectionsHloramkol eye drops are applied for treatment
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• Acute bacterial conjunctivitisS01AA11 gentamicin
GentokulinAntibiotic
Brand name INNGentokulin gentamicin
ATC DDD PregnancyS01AA11 C
Form and package Lactationeye drops 10 ml 0,3 % Avoid
INDICATIONSGentokulin is intended to:• treatment of superficial eye infections and ear infections
caused by susceptible microorganisms• for the prophylaxis of infections in trauma to the eye or ear.
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S01AX OTHER ANTIINFECTIVESS01AX13 ciprofloxacin
Marocen 0,3%
eye dropsBrand name INNMarocen ciprofloxacin
ATC DDD PregnancyS01AX13 C
Form and package Lactationeye drops 1 x 5 ml 0,3% Avoid
INDICATIONSCiprofloxacin is indicated for the treatment of corneal ulcers and superficial infection of the eye and adnexa, caused by susceptible microorganisms.It is necessary to keep the official guide on the rational use of antibiotic.
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S01B ANTIINFLAMMATORY AGENTSS01BA CORTICOSTEROIDS, PLAINS01BA04 prednisolone
OftalmolCorticosteroid
Brand name INNOftalmol prednisolone
ATC DDD PregnancyS01BA04 B
Form and package Lactationeye drops 5 ml 0,5 % Compatible
INDICATIONSOftalmol is intended for the treatment of inflammation •of the anterior segment of the eye without the presence of bacterial, viral or fungal infections: blepharitis, conjunctivitis, keratitis, keratoconjunctivitis, uveitis.
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S01C CORTICOSTEROIDS AND ANTI-INFECTIVES IN COMBINATIONS01CA CORTICOSTEROIDS AND ANTI-INFECTIVES IN COMBINATIONS01CA01 dexamethasone, neomycin
Neodeksacineye drops
Brand name INNNeodeksacin dexamethasone, neomycin
ATC DDD PregnancyS01CA01 C
Form and package Lactationeye drops 10 ml (0,5 % + 0,1) Avoid
INDICATIONSNeodeksacin used in conditions that require corticosteroid therapy, such as inflammation of the eye, bacterial infection and the presence of risk of bacterial eye infections.Neodeksacin is indicated in the following conditions:• Inflammation of the anterior segment of the eye• conjunctivitis• Inflammation of the cornea
• Chronic anterior uveitis• Corneal injury (burns resulting from the effects of chemical,
radiation or thermal means, or penetration of foreign bodies).
The combined use of anti-infective component of the drug is indicated in case of high risk or in situations which are expected to bacterial superinfection of the eye.Anti-infective component of this drug is active according to the following bacterial strains:• Staphylococcus aureus• Escherichia coli• Haemophilus influenzae• Klebsiella / species• Neisseria speciesNeodeksacin not provide adequate protection against the following microorganisms:• Pseudomonas aeruginosa• Serratia marcescens• Streptococcus spp. (including Streptococcus pneumoniae)
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S01E ANTIGLAUCOMA PREPARATIONS AND MIOTICSS01EB PARASYMPATHOMIMETICSS01EB01 pilocarpine
Miokarpinmiotic
Brand name INN
Miokarpin pilocarpine
ATC DDD Pregnancy
S01EB01 LOC 0,4 ml C
Form and package Lactation
eye drops 1 x 10 ml 2% Caution
INDICATIONSMiokarpin as miotic applied in the treatment of:•reduction of elevated intraocular pressure in patients with •open-angle glaucoma or ocular hypertension acute closed angle glaucomaPrevention of postoperative elevated intraocular pressure •associated with the laser operationto induce miosis.•
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S01EE PROSTAGLANDIN ANALOGUESS01EE01 latanoprost
Visuslatanoprost
Brand name INNVisus latanoprost
ATC DDD PregnancyS01EE01 C
Form and package LactationEye drops, 50 µg/ml Caution
INDICATIONSReduction of elevated intraocular pressure in patients •with open-angle glaucoma and intraocular hypertension
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S01G DECONGESTANTS AND ANTIALLERGICS S01GA SYMPATHOMIMETICS USED AS DECONGESTANTSS01GA01 naphazoline
HemokulinVasoconstrictor
Brand name INNHemokulin naphazoline
ATC DDD PregnancyS01GA01 C
Form and Package Lactationeye drops 10 ml 0,03 % Caution
INDICATIONSHemokulin, eye drops are used for temporary symptomatic remove redness caused by minor irritation.
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S01GA02 tetryzoline
MontevizinVasoconstrictor
Brand name INNMontevizin tetryzoline
ATC DDD PregnancyS01GA02 C
Form and Package Lactationeye drops 10 ml 0,05 %eye drops 15 ml 0,05 %
Avoid
INDICATIONSHyperemia and / or edema of the conjunctiva caused by a variety of non-specific causes, such as tonometry, placing and fitting of contact lenses, dust, smoke, smog, sun, cold, wind, allergies, swimming, reading, driving, watching television, etc.
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DRUGS SOLD WITHOUT A PRESCRIPTION (OTC)
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A ALIMENTARY TRACT & METABOLISMA01 DENTAL PREPARATIONSA01A DENTAL PREPARATIONSA01AB Anti-infectives and antiseptics for local therapy of oral cavityA01AB12 hexetidine
Hexoral
Brand name Generic name
Hexoral hexetidine
ATC DDD Pregnancy
A01AB12
Form and Package Breastfeeding
Sol.for mouth rinsing 200 ml
INDICATIONS
Hexetidine as a local antiseptic is recommended for the treatment of superficial oropharyngeal infections, including ulcers and their prevention (eg, recurrent aphthous ulcers). It helps in the prevention and treatment of gingivitis. It is also used for preoperative performance of dental and surgical procedures in the oral cavity. Also, the use of heksetidina recommended for bad breath from the mouth (foetor ex ore).
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A02 DRUGS FOR ACID RELATED DISORDERS A02A ANTACIDSA02AD05 Aluminium magnesium silicate hydrate
Gelusil LacAntacid
Brand name INN
Gelusil Lac Aluminium magnesium silicate hydrate
ATC DDD Pregnancy
A02AD05 No data
Form and package Lactation
Tbl. 40 x 500 mg Excreted into human breast milk. Problems have not been documented in humans.
INDICATIONS
• Relieve the symptoms of hyperacidity.
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A06 DRUGS FOR CONSTIPATIONA06A Drugs for constipationA06AB Contact laxativesA06AB02 bisacodyl
PanlaxContact laxative
Brand name INN
Panlax bisacodyl
ATC DDD Pregnancy
A06AB02 O, R 10 mg B
Form and package Lactation
gastroresistant tablets 6 x 10 mgsuppositories 6 x 10 mg
Although not excreted into breast milk, it's not recommended in breast feeding
INDICATIONS
Short-term symptomatic treatment of constipation.As recommended by physicians to prepare for radiology, diagnostic and surgical procedures that require the bowel emptying.
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A07 ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTSA07A INTESTINAL ANTIINFECTIVESA07AA Antibiotics A07AA02 nystatin
NystatinAntimycotic
Brand name INN
Nystatin nystatin
ATC DDD Pregnancy
A07AA02 O 1,5 MU C
Form and package Lactation
10 coated tablets x 500.000 i.u.24 ml oral susp. 100.000 i.u/ml Not excreted into milk.
INDICATIONSNystatin powder for oral suspension is used in the prevention and treat-ment of fungal infections of the mouth, esophagus and intestinal tract caused by fungi of the genus Candida spp. It is used in the prevention of oral candidiasis in newborns whose mothers had vaginal candidiasis.NYSTATIN tablets are intended for the treatment of gastrointestinal can-didiasis.
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A11 VITAMINSA11H OTHER PLAIN VITAMIN PREPARATIONSA11HA OTHER PLAIN VITAMIN PREPARATIONSA11HA30 dexpanthenol
PanthenolVitamin
Brand name Generic name
Panthenol dexpanthenol
ATC DDD Pregnancy
A11HA30 No data available
Form and Package Breastfeeding
lozenges 20 x 120 mg No data available
INDICATIONS
Relieve symptoms of Inflammation of oral mucosa, throat, tongue •and gingiva (stomatitis, aphtous ulcers, glossitis, pharyngitis, laryngitis).
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B BLOOD AND BLOOD FORMING ORGANSB01A ANTITHROMBOTIC DRUGSB01AC INHIBITORS OF PLATELET AGGREGATION, EXCL. HEPARINB01AC06 acetylsalicylic acid
Midol 100inhibitor of platelet aggregation
Brand name Generic nameMidol 100 acetylsalicylic acid
ATC DDD PregnancyB01AC06 O 3 g C (1,2) D (3)
Form and Package BreastfeedingTablets 20 x 100 mg Avoid usage during breastfeeding.
Possible appearance of Rey syndrome. Frequent usage of high doses can damage thrombocyte function and cause hypoprothrombinemia at breastfed infant.
INDICATIONS
Acetylsalicylic acid tablets are indicated for use in the following cases, •based on their properties of inhibition of platelet aggregation:To reduce the risk of mortality in patients with suspected acute •myocardial infarction;
To reduce the risk of morbidity and mortality in patients who have had •previously a myocardial infarction;For secondary prevention of stroke;•To reduce the risk of transient ischemic attack (TIA) and stroke in •patients suffering from TIATo reduce the risk of morbidity and death in patients with stable and •unstable angina pectoris;For the prevention of thromboembolism after surgery or vascular •surgery, for example. PTCA, CABG, carotidendarterectomy, arteriovenous shunts in dialysis patients;For prophylaxis of deep vein thrombosis and pulmonary embolism •after prolonged immobilization, such as after a major surgical procedures;To reduce the risk of first myocardial infarction in people with risk •factors for development of cardiovascular disease, for example diabetes mellitus, hyperlipidemia, hypertension, obesity, smoking and age.
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C CARDIOVASCULAR SYSTEM
C05 VASOPROTECTIVESC05A AGENTS FOR TREATMENT OF HEMORRHOIDS AND ANAL FISSURES FOR TOPICAL USEC05AA CORTICOSTEROIDSC05AA04 heparin, prednisolone, polidocanol
Hepathrombin Hantihemorrhoidal preparation
Brand name INNHepathrombin H heparin, prednisolone,
polidocanol
ATC DDD PregnancyC05AA04 C
Form and Package Lactationointment 20 g (65 i.u.+2,233 mg+30 mg)/gsuppositories 10 x (120 i.u.+1,675 mg+30 mg)
No excretion into breast milk, save use during breastfeeding.
INDICATIONSIn the symptomatic treatment of hemorrhoids and itching in the perianal region in the short period of time.
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C05 VASOPROTECTIVESC05B ANTIVARICOSE THERAPYC05BA HEPARINS OR HEPARINOIDS FOR TOPICAL USE C05BA53 heparin, combinations
Hepathrombinantivaricose therapy
Brand name INN
Hepathrombin heparin, dexpanthenol, alantoin
ATC DDD Pregnancy
C05BA53 C
Form and Package Lactation
gel 30000 40 gcream 30000 40 ggel 50000 40 gcream 50000 40 g
No excretion into breast milk, save use during breastfeeding.
INDICATIONS
Surface thrombophlebitis•Relief of symptoms in superficial bruising and hematoma•
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C05 VASOPROTECTIVESC05B ANTIVARICOSE THERAPYC05BA HEPARINS OR HEPARINOIDS FOR TOPICAL USE C05BA53 heparin, combinations
Sinedol Gelantivaricouse therapy
Brand name Generic name
Sinedol gel heparin, dimethyl sulfoxide, dexpanthenol
ATC DDD Pregnancy
C05BA53 C
Form and Package Breastfeeding
gel 40 g (500 i.u.+150 mg+25 mg)/g No excretion into breast milk, safe usage during breastfeeding.
INDICATIONS
Sinedol gel is a combination of active substances intended for the treatment of sports injuries and other injuries of muscles, tendons, synovias and ligaments of the joints caused by bluntforce: contusions, hematomas, distortion,tennis elbow, tendons and synovial inflammation, bursitis. Also indicated in the treatment of peripheral venopathy, acute neuralgia, and humero-scapular periarthritis.
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D DERMATOLOGICALS D01 ANTIFUNGALS FOR DERMATOLOGICAL USED01A ANTIFUNGALS FOR TOPICAL USED01AA AntibioticsD01AA01 nystatin
NystatinAntimycotic
Brand name Generic name
Nystatin nystatin
ATC DDD Pregnancy
D01AA01 C
Form and Package Breastfeeding
Ointment 5 g 100.000 i.u./gOintment 20 g 100.000 i.u./g
Not excreted into milk.
INDICATIONS
Nystatin ointment for the treatment of cutaneous and mucocutane-ous infections caused by Candida (Monilia) albicans and other Candida strains.
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D01AC IMIDAZOLE AND TRIAZOLE DERIVATIVESD01AC08 ketoconazole
Mycosebantifungal
Brand name Generic name
Mycoseb ketoconazole
ATC DDD Pregnancy
D01AC08 O 0,2 g C
Form and Package Breastfeeding
shampoo 2% 1 x 100 ml Possible excretion into breast milk. Avoid.
INDICATIONS
Prevention and treatment of infections that are believed to be •caused by the yeast Malassezia (formerly Pityrosporum), such as dandruff, seborrheic dermatitis and tinea (pityriasis) versicolor.
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D03 PREPARATIONS FOR TREATMENT OF WOUNDS AND ULCERSD03A CICATRIZANTSD03AX OTHAR CICATRIZANTSD03AX03 dexpanthenol
PanthenolVitamin
Brand name Generic name
Panthenol dexpanthenol
ATC DDD Pregnancy
D03AX03 No data available
Form and Package Breastfeeding
ointment 30 g 5 % No data available
INDICATIONS
Burns of first and second degree, •Irritation of skin caused by UV rays, •Rash of gluteal parts of infants, •Fissures of breast nipples at women in breastfeeding period, •Chronic skin ulcers, •Decubitus ulcers, •Skin transplants – in reciprocation with cortisone therapy, •Treatment of dry, callously and aged skin.•
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D08 ANTISEPTICS AND DISINFECTANTSD08A ANTISEPTICS AND DISINFECTANTSD08AG IODINE PRODUCTSD08AG02 povidone-iodine
Povidon jodantiseptic, disinfectant
Brand name Generic name
Povidon jod povidone-iodine
ATC DDD Pregnancy
D08AG02 Possible absorption of iodine and effect on thyroid gland of fetus
Form and Package Breastfeeding
ointment 1% 1 x 40 gfoam 5 lfoam 500 mlsolution 100 mlsolution 500 ml
Avoid
INDICATIONSPovidone-iodine ointment
Povidone-iodine ointment is abroad spectrum antiseptic for topical •treatment or prevention of infection in minor cuts and abrasions, simple surgical procedures and small burns.Povidone-iodine ointmentis intended also for the treatment of •fungal and bacterial skin infections, pyoderma, treatment of decubitus infections and ulcus cruris.
Povidone-iodine solutionPovidone iodine solution intended for disinfecting the skin and •mucous membranes before and after complex and simple surgery.
Povidone-iodine foamPovidone iodine skin foam intended for hand disinfection of •surgical staff and patient preoperative skin preparation
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G GENITO URINARY SYSTEM AND SEX HORMONES
G01 GYNECOLOGICAL ANTIINFECTIVES AND ANTISEPTICSG01A ANTIINFECTIVES AND ANTISEPTICS, EXCL. COMBINATIONS WITH
CORTICOSTEROIDSG01AX OTHER ANTIINFECTIVES AND ANTISEPTICSG01AX11 povidone-iodine
Povidon jod anti-infective, antiseptic
Brand name Generic name
Povidon jod povidone-iodine
ATC DDD Pregnancy
G01AX11 Possible absorption of iodine and effect on thyroid gland of fetus
Form and Package Breastfeeding
vaginal tablets 14 x 20 mg Avoid
INDICATIONS
Treatment of vaginitis caused by • Candida, Trichomonas, for the treatment of non-specific and mixed infection and preoperative preparation of the vagina.
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M MUSCULO-SKELETAL SYSTEMM01AE Propionic acid derivativesM01AE01 ibuprofen
IbuprofenNSAID
Brand name Generic name
Ibuprofen ibuprofen DL-lysinate
ATC DDD Pregnancy
M01AE01 O 1,2 g C
Form and Package Breastfeeding
20 eff.tablets x 200 mg Compatible with breast feeding as minimal amounts excreted into milk.
INDICATIONS
The drug is intended to eliminate mild to moderate pain such as •headache, back pain, rheumatic or muscle pain, dysmenorrhea, toothache, lower fever and to relieve the symptoms colds and flu.
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M MUSCULO-SKELETAL SYSTEM
M02 TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAINM02A TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAINM02AA ANTIINFLAMMATORY PREPARATIONS, NON-STEROIDS FOR TOPICAL USE M02AA15 diclofenac
Diclofenac NSAID
Brand name Generic name
Diclofenac diclofenac
ATC DDD Pregnancy
M02AA15 O,P,R 0,1 g C (D in 3rd trimester and in time of baby delivery)
Form and Package Breastfeeding
gel 40 g 1% Caution
INDICATIONS
Local symptomatic relief of pain and inflammation in:•
injuries of tendons, ligaments, muscles and joints (expansions, •dislocations and contusions)
localized forms of soft tissue rheumatism•
To relieve pain in mild arthritic conditions.•
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N NERVOUS SYSTEM N02 ANALGESICSN02B OTHER ANALGESICS AND ANTIPYRETICSN02BA SALICYLIC ACID AND DERIVATIVESN02BA01 acetylsalicylic acid
Midolanalgesic, antipyretic
Brand name Generic name
Midol acetylsalicylic acid
ATC DDD Pregnancy
N02BA01 O 3 g C (1,2) D (3)
Form and Package Breastfeeding
tablets 500 x 300 mg Avoid usage during breastfeeding. Possible appearance of Rey syndrome. Frequent usage of high doses can damage thrombocyte function and cause hypoprothrombinemia at breastfed infant.
INDICATIONS
The pain of mild and moderate intensity: headache, toothache, •neuralgia, arthralgia, muscle pain and similar painful conditions.
Fever in adults: influenza, the common cold or similar infectious •conditions that are accompanied by fever.
Secondary prevention of myocardial infarction.•
Unstable angina pectoris.•
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N02BE01 paracetamol
Febricetanalgesic, antipyretic
Brand name Generic name
Febricet paracetamol
ATC DDD Pregnancy
N02BE01 O 3 g No harmful effects to fetus have been reported.
Form and Package Breastfeeding
syrup 100 ml (120 mg/5 ml)suppositories 5 x 200 mg
Safe to use. Rash has been reported in breastfed infants.
INDICATIONSFEBRICET a mild analgesic and antipyretic. It is recommended that •its short-term use in the following statesheadaches•musculoskeletal disorders•menstrual pain•toothache•symptomatic treatment of colds and flu•mild to moderate pain associated with osteoarthritis•Syrup•For the symptomatic treatment of mild upper respiratory tract •infections caused by virusesfever after immunization•weak to moderately severe pain (headache, toothache, menstrual pain)•Suppositories•Symptomatic treatment of mild to moderately severe pain and /or fever•
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N02BE01 paracetamol
Grippostad hot drinkanalgesic, antipyretic
Brand name Generic name
Grippostad hot drink paracetamol
ATC DDD Pregnancy
N02BE01 O 3 g No harmful effects to fetus have been reported.
Form and Package Breastfeeding
Sachet 5x5 g/600 mg Safe to use. Rash has been reported in breastfed infants.
INDICATIONSSymptomatic treatment of mild to moderate pain (such as headache, toothache, menstrual pain and / or fever).It is used in children older than 10 years, adolescents and adults.
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N02BE ANILIDESN02BE51 Paracetamol, combinations excl. psycholeptics
Caffebolanalgesic, antipyretic
Brand name Generic name
Caffebol paracetamol, caffeine, codeine
ATC DDD Pregnancy
N02BE51 C, D in long term use
Form and Package Breastfeeding
tablets 500 x (460+50+10 mg) Not enough data available. Poten-tially toxic for child.
INDICATIONSQuickly relieve symptoms of pain. Caffebol is indicated for short •term treatment of acute moderate pain that does not respond to paracetamol, ibuprofen or aspirin monotherapy: headache, migraine, menstrual pain, toothache, neuralgia and rheumatic pain (including myalgia, and back pain).
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N02BE51 Paracetamol, combinations excl. psycholeptics
Febricet Canalgesic, antipyretic
Brand name Generic name
Febricet C paracetamol, ascorbic acid
ATC DDD Pregnancy
N02BE51 O 3 g No harmful effects to fetus have been reported.
Form and Package Breastfeeding
eff. tablets 10 x (330+200 mg) Safe to use. Rash has been report-ed in breastfed infants.
INDICATIONS
Symptomatic treatment of colds and influenza (high temperature, •chills, and fever), and relieve mild to moderately severe pain such as headaches. Ascorbic acid is a supplement of vitamin C, in deficient conditions such as the flu or a cold.
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R RESPIRATORY SYSTEMR01 NASAL PREPARATIONSR01A Decongestants and other nasal preparations for topical useR01AA Sympathomimetics, plain
Nafazol 0,5‰, 1‰Nasal decongestant
Brand name Generic name
Nafazol naphazoline
ATC DDD Pregnancy
R01AA08 N 0,4 mg C
Form and Package Breastfeeding
Nasal drops, solution 10 ml Unknown excretion into breast milk. No problems have been documented in humans.
INDICATIONSSymptomatic treatment of congestion of the nasal mucosa
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R01B NASAL DECONGESTANTS FOR SYSTEMIC USER01BA SYMPATHOMIMETICS R01BA52 pseudoephedrine, combinations
∆RinasekSympathomimetic
Brend name Generic name
Rinasek triprolidine, pseudoefedrine
ATC DDD Pregnancy
R01BA52 O, 0,24 g C, B
Form and Package Lactation
syrup 100 ml (5 ml/1,25+30 mg)tablets 10 x (2,5+60 mg)
safe in breast feeding
INDICATIONSAllergic rhinitis – seasonal and nonseasonal•Vasomotor (perennial) rhinitis•Rhinitis, cold•
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R02 THROAT PREPARATIONSR02A THROAT PREPARATIONSR02AA ANTISEPTICSR02AA15 povidone-iodine
Povidon jodantiseptic
Brand name Generic name
Povidon jod povidone-iodine
ATC DDD Pregnancy
R02AA15 Possible absorption of iodine and effect on thyroid gland of fetus
Form and Package Breastfeeding
solution 0.85% 1 x 50 ml Avoid
INDICATIONS
Acute infections of the mouth and throat mucosa, for example. •gingivitis and mouth ulcers.Oral hygiene, before, during and after dental procedures and •interventions in the oral cavity.
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R05 COUGH AND COLD PREPARATIONSR05C EXPECTORANTS, EXCL. COMBINATIONS WITH COUGH SUPPRESSANTSR05CB MUCOLYTICSR05CB06 ambroxol
Ambroksolmucolytic
Brand name Generic name
Ambroksol ambroxol
ATC DDD Pregnancy
R05CB06 O 0,12 g No data available
Form and Package Breastfeeding
syrup 100 ml 15 mg/5 ml eff. tablets 20 x 30 mgeff. tablets 10 x 60 mg
No data available
INDICATIONS
Mucolytic therapy in acute and chronic bronchopulmonary diseases associated with increased production and disorder formation and transport of mucus.
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R05CB03 carbocisteine
MucodyneMucolytic
Brand name Generic name
Mucodyne Carbocisteine
ATC DDD Pregnancy
R05CB03 O 1,5 g No data available. Avoid.
Form and Package Breastfeeding
capsules 30 x 375 mgsyrup 100 ml (125 mg/5 ml) 2,5%syrup 100 ml (250 mg/5 ml) 5%
No data available.
INDICATIONS
Carbocisteine is mucolytic, and he is indicated for the adjuvant treatment of disorders of the respiratory tract caused by thick viscous secretions, including obstruction of the airways.
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R06AB54 paracetamol, ascorbic acid, caffeine, chlorphenamine
Grippostad Canalgesic, antipyretic
Brand name Generic name
Grippostad C paracetamol, ascorbic acid, caffeine, chlorphenamine
ATC DDD Pregnancy
R06AB54 X
Form and Package Breastfeeding
10 caps.x (200 mg + 150 mg +25 mg + 2,5 mg) Contraindicated
INDICATIONSTreatment of the symptoms of colds and flu infections, such as headache, muscle aches, nasal congestion and dry cough. GRIPPOSTAD® C leads to the reduction of fever.Because of the fixed combination of active substances in drug GRIPPOSTAD® C, the dose can be individually configured with respect to the predominant symptom. In such cases you should take your medicine of a different composition.
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S SENSE ORGANSS01 DRUGS FOR THE TREATMENT OF EYE AND EARS01KA02 hypromellose
HemodropsViscoelastic substances
Brand name Generic name
Hemodrops hypromellose
ATC DDD Pregnancy
S01KA02 No data
Form and Package Breastfeeding
Eye drops 0,5% 10 ml No data
INDICATIONSHemodrops, eye drops are used locally, for the symptomatic treatment of eye dryness (the syndrome of “dry eye “- keratoconjunctivitis sicca and xerophtalmia, eye irritation associated with insufficient tears production, the reduced secretion of tears in the elderly, as well as neuroparalytic tears hyposecretion).Also, it is used to prevent damage to the cornea when wearing hard contact lenses, while used as adjuvant therapy for disorders precorneal tear film (staphylococcal blepharitis and keratoconjunctivitis, herpetic keratitis, chemical and thermal eye injury).