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Public Assessment Report
UKPAR
Amoxicillin 125 mg/5 ml Oral Suspension Sugar Free
Amoxicillin 250 mg/5 ml Oral Suspension Sugar Free
(amoxicillin trihydrate)
UK Licence No: PL 30464/0088-0091
Athlone Pharmaceuticals Limited
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Lay Summary
Amoxicillin 125 mg/5 ml and 250 mg/5 ml Oral Suspension Sugar Free
(amoxicillin trihydrate)
This is a summary of the Public Assessment Report (PAR) for duplicate applications
for Amoxicillin 125 mg/5 ml and 250 mg/5 ml Oral Suspension Sugar Free (PL
30464/0088-0091). These medicinal products will be referred to as Amoxicillin Oral
Suspension in the remainder of this summary, for ease of reading.
This summary explains how the applications for Amoxicillin Oral Suspension were
assessed and their authorisation recommended, as well as their conditions of use. It is
not intended to provide practical advice on how to use these products.
For practical information about using Amoxicillin Oral Suspension, patients should
read the Patient Information Leaflet (PIL) or contact their doctor or pharmacist.
What is Amoxicillin Oral Suspension and what is it used for?
These medicines are the same as Amoxicillin 125 mg/5ml and 250 mg/5 ml Oral
Suspension Sugar Free BP/Respillin 125 mg/5ml and 250 mg/5 ml Oral Suspension
Sugar Free BP (PL 06453/0049-0050; Athlone Laboratories Limited), which are
already authorised and are held by the applicant (Athlone Pharmaceuticals Limited).
The company (Athlone Pharmaceuticals Limited) referred to data provided by
Athlone Laboratories Limited for the grant of licences for Amoxicillin 125 mg/5ml
and 250 mg/5 ml Oral Suspension Sugar Free BP/Respillin 125 mg/5ml and 250 mg/5
ml Oral Suspension Sugar Free BP (PL 06453/0049-0050) as the basis for the grant of
licences for Amoxicillin Oral Suspension (PL 30464/0088-0091).
Amoxicillin Oral Suspension can treat a wide range of infections including the
following:
- Chest (bronchitis or pneumonia)
- ears (otitis media)
- kidneys
- heart (endocarditis)
- tonsils (tonsillitis)
- sinuses (sinusitis)
- teeth
- blood (septicaemia)
- skin
- gums (abscesses)
- bone
- the bladder or the urethra (the tube which carries urine from the bladder)
- the female reproductive system including infections caused by difficulties
during childbirth (puerperal sepsis and septic abortion)
- abdomen (intra-abdominal sepsis and peritonitis)
- gonorrhoea (a sexually transmitted infection)
- infections associated with pregnancy
- typhoid and paratyphoid (fevers caused by a group of bacteria called
Salmonella)
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How does Amoxicillin Oral Suspension work?
Amoxicillin Oral Suspension contains the active ingredient amoxicillin trihydrate,
which belongs to a group of antibiotic medicines called penicillins.
This medicine works by interfering with the bacteria that causes the infection.
How is Amoxicillin Oral Suspension used?
Amoxicillin Oral Suspension is taken by mouth. The suspension may be taken before,
with or after food unless the label advises a specific time.
In adults (including the elderly) the total daily dose should not exceed 6 g in total,
given in divided doses. The usual dose for most infections is 5 ml of 250 mg/5 ml to
be taken 3 times a day. For more serious infections the dose may be doubled to 10 ml
of 250 mg/5 ml 3 times a day
• The following doses may be given in the following conditions:
- Severe or recurrent chest infections: 3 g twice daily
- Simple urinary tract infections: two 3 g doses 10 to 12 hours between doses
(short course)
- Dental abscesses: two 3 g doses given orally with 8 hours between doses
- Gonorrhoea: a single 3 g dose
• The following are the usual doses for preventing infection during dental
procedures or other surgery:
- If a general anaesthetic is not used, 3 g given orally one hour before surgery
and another dose six hours later if necessary
- If a general anaesthetic is used, 3 g given orally four hours before anaesthesia
and 3 g six hours after the initial dose
Children weighing more than 40 kg should be given the usual adult dosage. The total
daily dose in children less than 40 kg should not exceed 3 g in total, given in divided
doses. All doses are worked out depending on the child’s body weight in kilograms.
Advice is given by a doctor on how much medicine should be given to a baby or
child. The usual dose is 40 mg to 90 mg for each kilogram of body weight a day,
given in two or three divided doses.
Patients with kidney problems may be prescribed a lower dose than usual.
Amoxicillin Oral Suspension can only be obtained with a prescription from a doctor.
For further information on how Amoxicillin Oral Suspension is used, please see the
Summaries of Product Characteristics or the package leaflet available on the MHRA
website.
What benefits of Amoxicillin Oral Suspension have been shown in studies? As Amoxicillin Oral Suspension (PL 30464/0088-0091) is considered to be identical
to the reference products, Amoxicillin 125 mg/5ml and 250 mg/5 ml Oral Suspension
Sugar Free BP/Respillin 125 mg/5ml and 250 mg/5 ml Oral Suspension Sugar Free
BP (PL 06453/0049-0050), its benefits and risks are taken as being the same as those
for the reference products.
What are the possible side effects from Amoxicillin Oral Suspension?
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Like all medicines, this medicine can cause side effects, although not everybody gets
them.
For the full list of all side effects reported with Amoxicillin Oral Suspension, see
section 4 of the package leaflet.
For the full list of restrictions, see the package leaflet.
Why is Amoxicillin Oral Suspension approved?
No new or unexpected safety concerns arose from these duplicate applications. It was,
therefore, considered that the benefits of Amoxicillin Oral Suspension outweigh the
risks, and the grant of Marketing Authorisations was recommended.
What measures are being taken to ensure the safe and effective use of
Amoxicillin Oral Suspension?
A satisfactory pharmacovigilance system has been provided to monitor the safety of
these products. Safety information has also been included in the Summaries of
Product Characteristics and the package leaflet for Amoxicillin Oral Suspension,
including the appropriate precautions to be followed by healthcare professionals and
patients.
Other information about Amoxicillin Oral Suspension
Marketing Authorisations were granted in the UK on 9th
April 2015.
For more information about taking Amoxicillin Oral Suspension, read the patient
information leaflet (PIL), or contact your doctor or pharmacist.
The full PAR for Amoxicillin Oral Suspension follows this summary.
This summary was last updated in May 2015.
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Table of Contents
I Introduction Page 6
II Quality aspects Page 7
III Non-clinical aspects Page 9
IV Clinical aspects Page 10
V User consultation Page 10
VI Overall conclusion, benefit/risk assessment and
recommendation
Page 10
Table of content of the PAR update
Page 36
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I Introduction The Medicines and Healthcare products Regulatory Agency (MHRA) granted Athlone
Pharmaceuticals Limited Marketing Authorisations for the medicinal products
Amoxicillin 125 mg/5 ml and 250 mg/5 ml Oral Suspension Sugar Free (PL
30464/0088-0091) on 9th
April 2015. These products are prescription only medicines
(POM) indicated for the treatment of commonly-occurring bacterial infections
including, acute and chronic bronchitis, pneumonia, ear, nose and throat infections,
otitis media, urinary tract infection, gonorrhoea, invasive salmonellosis,
gynaecological infections, peritonitis, osteomyelitis, meningitis, endocarditis and
typhoid fever.
Prophylaxis of endocarditis in patients at risk from such procedures as dental
extractions.
In some of these infections initiation of treatment or indeed the whole course of
treatment may need to be by the parenteral route.
In children with urinary tract infection, the need for further clinical investigation
should be considered.
These applications were submitted as abridged simple applications, according to
Article 10c of Directive 2001/83/EC, as amended. The applicant has cross-referred to
Amoxicillin 125 mg/5 ml and 250 mg/5 ml Oral Suspension Sugar Free BP/Respillin
125 mg/5 ml and 250 mg/5 ml Oral Suspension Sugar Free BP, which were
authorised to Athlone Laboratories Limited (PL 06453/0049-0050) on 22nd
July 1997.
Amoxicillin is a broad spectrum antibiotic which is bactericidal for both gram positive
and gram negative bacteria. Amoxicillin is well absorbed by the oral route. Oral
administration, usually at convenient three-times-a-day dosage, produces high serum
levels independent of the time at which the food is taken. Amoxicillin gives good
penetration into bronchial secretions and high urinary concentrations of unchanged
antibiotic. It is rapidly bactericidal and possesses the safety profile of a penicillin.
No new data were submitted nor were they necessary for these simple applications, as
the data are identical to those of the previously granted cross-reference products.
The MHRA has been assured that acceptable standards of Good Manufacturing
Practice (GMP) are in place for these product types at all sites responsible for the
manufacture and assembly of these products.
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II Quality aspects II.1 Introduction
These are abridged applications for Amoxicillin 125 mg/5 ml and 250 mg/5 ml Oral
Suspension Sugar Free, submitted under Article 10c of Directive 2001/83/EC, as
amended. The applicant has cross-referred to Amoxicillin 125 mg/5 ml and 250 mg/5
ml Oral Suspension Sugar Free BP/Respillin 125 mg/5 ml and 250 mg/5 ml Oral
Suspension Sugar Free BP, which were authorised to Athlone Laboratories Limited
(PL 06453/0049-0050) on 22nd
July 1997. The current applications are considered
valid.
II.2 Drug Substance Amoxicillin trihydrate
The drug substance specification is identical to that of the reference products and is
acceptable.
II.3 Medicinal Product Name
The proposed product names for these applications are Amoxicillin 125 mg/5 ml Oral
Suspension Sugar Free and Amoxicillin 250 mg/5 ml Oral Suspension Sugar Free.
The products have been named in line with current requirements.
Strength, pharmaceutical form, route of administration, container and pack size
Amoxicillin Sugar Free Suspension 125 mg/5ml and 250 mg/5 ml contains
amoxicillin trihydrate equivalent to amoxicillin 125 mg and 250 mg respectively. The
route of administration is oral.
The finished product is packaged in to high-density polyethylene bottles with tamper-
evident and child-resistant cap containing 100 ml of the suspension. The carton may
also contain a polypropylene spoon, medispoon or a dosing syringe with a bottle neck
adaptor.
The proposed shelf-life is 30 months for 125 mg/5 ml and 3 years for 250 mg/5 ml for
the unopened bottle with a storage condition for the dry powder of “Store in a dry
place below 25°C”. Reconstituted suspension may be stored for up to 14 days at 2°-
8°C in a refrigerator. These are acceptable.
The proposed packaging, shelf-life and storage condition are consistent with the
details registered for the cross-reference products.
Legal status
These products are prescription only medicines (POM).
Marketing Authorisation Holder/Contact Persons/Company
Athlone Pharmaceuticals Limited, Ballymurray, Co. Roscommon, Ireland.
The Qualified Person (QP) responsible for pharmacovigilance is stated and a
satisfactory CV has been provided.
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Manufacturers
The proposed manufacturing sites are consistent with those registered for the
cross-reference products and evidence of Good Manufacturing Practice (GMP)
compliance has been provided.
Qualitative and quantitative composition
The proposed compositions are consistent with the details registered for the
cross-reference products.
Manufacturing processes
The proposed manufacturing processes are consistent with the details registered for
the cross-reference products and the maximum batch size is stated.
Finished product/shelf-life specifications The proposed finished product specifications, at release and shelf life, are in line with
the details registered for the cross-reference products.
TSE Compliance
None of the excipients contain materials of animal or human origin. This is consistent
with the cross-reference products.
Bioequivalence
No bioequivalence data are required to support these simple abridged applications as
the proposed products are manufactured to the same formula utilising the same
processes as the cross-reference products, Amoxicillin 125 mg/5 ml and 250 mg/5 ml
Oral Suspension Sugar Free BP/Respillin 125 mg/5 ml and 250 mg/5 ml Oral
Suspension Sugar Free BP (PL 06453/0049-0050).
Expert Report
The applicant cross-refers to the data for Amoxicillin 125 mg/5 ml and 250 mg/5 ml
Oral Suspension Sugar Free BP/Respillin 125 mg/5 ml and 250 mg/5 ml Oral
Suspension Sugar Free BP (PL 06453/0049-0050) to which this application is claimed
to be identical. This is acceptable. The applicant has included detailed expert reports
of the applications. Signed declarations and copies of the experts’ CVs are enclosed
for the quality, non-clinical and clinical experts. All are considered to have sufficient
experience for their responsibilities.
II.4 Discussion on chemical, pharmaceutical and biological aspects The data submitted with the applications are acceptable. The grant of Marketing
Authorisations is recommended.
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III Non-clinical aspects Introduction
As these are abridged applications submitted under Article 10c of Directive
2001/83/EC, as amended, no new non-clinical data has been supplied and none are
required.
Ecotoxicity/environmental risk assessment (ERA)
A suitable justification has been provided for not submitting an environmental risk
assessment.
Discussion on the non-clinical aspects
The grant of Marketing Authorisations is recommended.
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IV Clinical aspects As these are abridged applications submitted under Article 10c of Directive
2001/83/EC, as amended, no new clinical data have been supplied and none are
required.
The grant of Marketing Authorisations is recommended.
Risk Management Plan (RMP)
A satisfactory pharmacovigilance system has been provided, which fulfils the
requirements and provides adequate evidence that the applicant has the services of a
qualified person responsible for pharmacovigilance and has the necessary means for
the notification of any adverse reaction suspected of occurring either in the
Community or in a third country. A satisfactory justification has been provided for not
submitting a risk management plan.
V User consultation User-testing of the patient information leaflet (PIL) for Amoxicillin 125 mg/5 ml and
250 mg/5 ml Oral Suspension Sugar Free has been accepted based on the bridging
report provided by the applicant making reference to the successful user-testing of the
PIL for Amoxicillin 125 mg/5 ml and 250 mg/5 ml Oral Suspension Sugar Free
BP/Respillin 125 mg/5 ml and 250 mg/5 ml Oral Suspension Sugar Free BP (PL
06453/0049-0050) as the ‘parent PIL’.
VI Overall conclusion, benefit/risk assessment and
recommendation The quality of the products is acceptable, and no new non-clinical or clinical concerns
have been identified. The applicant’s products are identical to the reference products.
Extensive clinical experience with amoxicillin trihydrate is considered to have
demonstrated the therapeutic value of the compounds. The benefit-risk assessment is,
therefore, considered to be positive.
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Summary of Product Characteristics, Patient Information Leaflet &
Labels In accordance with Directive 2012/84/EU, the current approved UK versions of the
SmPCs and PIL for these products are available on the MHRA website.
Labelling
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Table of content of the PAR update
Steps taken after the initial procedure with an influence on the Public Assessment
Report (Type II variations, PSURs, commitments)
Date
submitted
Application
type
Scope Outcome
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