País: Irlanda
Idioma: anglès
Font: HPRA (Health Products Regulatory Authority)
AMOXICILLIN TRIHYDRATE
GlaxoSmithKline (Ireland) Limited
125 MG/5ml
Syrup
2002-04-01
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA1077/033/007 Case No: 2073852 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 AMOXIL SYRUP 125MG/5ML. 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 24/11/2009. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 24/11/2009_ _CRN 2073852_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Amoxil Syrup 125mg/5ml. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5 ml of syrup contains 125 mg amoxicillin (as trihydrate). Excipients: also contains sorbitol (E420), sulphur dioxide (E220) and ethanol. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder for oral suspension. An off-white free-flowing powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS In the treatment of infections due to organisms sensitive to amoxicillin. `Amoxil`is a broad spectrum antibiotic, indicated for the treatment of commonly occurring bacterial infections such as: Upper respiratory tract infections Otitis media A Llegiu el document complet