AUGMENTION JUNIOR
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
26-04-2024
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Active ingredient:
AMOXICILLIN TRIHYDRATE CLAVULANATE POTASSIUM
Available from:
GlaxoSmithKline (Ireland) Limited
Dosage:
125/62.5 MG/5ml
Pharmaceutical form:
Powder for Oral Suspension
Authorization date:
1983-07-28
Summary of Product characteristics
IRISH MEDICINES BOARD ACTS 1995 AND 2006
MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007
(S.I. NO.540 OF 2007)
PA1077/093/006
Case No: 2064670
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
GLAXOSMITHKLINE (IRELAND) LIMITED
STONEMASONS WAY, RATHFARNHAM, DUBLIN 16, IRELAND
an authorisation, subject to the provisions of the said Regulations, in respect of the product
AUGMENTIN JUNIOR 125MG/62.5MG PER 5ML POWDER FOR ORAL SUSPENSION
The particulars of which are set out in Part I and Part II of the attached Schedule. The authorisation is also subject to the general conditions as
may be specified in the said Regulations as listed on the reverse of this document.
This authorisation, unless previously revoked, shall continue in force from 08/02/2010.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 08/02/2010_
_CRN 2064670_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Augmentin Junior 125mg/62.5mg per 5ml Powder for Oral Suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml of reconstituted suspension contains Amoxicillin Trihydrate equivalent to 125 mg of amoxicillin and
potassium clavulanate equivalent to 62.5 mg of clavulanic acid.
Excipient: Each 5ml of reconstituted oral suspension contain 12.5mg of aspartane (E951)
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for oral suspension
White to off-white powder for reconstitution with water.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Augmentin is ind
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