Riik: Iirimaa
keel: inglise
Allikas: HPRA (Health Products Regulatory Authority)
AMOXICILLIN TRIHYDRATE
GlaxoSmithKline (Ireland) Limited
250mg Milligram
Capsule
2002-04-01
IRISH MEDICINES BOARD ACT 1995, AS AMENDED MEDICINAL PRODUCTS (CONTROL OF PLACING ON THE MARKET) REGULATIONS, 2007, AS AMENDED PA1077/033/001 Case No: 2084980 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 CAPSULES 250 MG. the particulars of which are set out in 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 30/06/2010. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 30/06/2010_ _CRN 2084980_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Amoxil Capsules 250 mg. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 250 mg amoxicillin (as trihydrate). For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Capsule, hard. (capsule) Maroon and gold capsules with ‘GS LEX' printed in white on the cap and body, containing a white 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 Acute and chronic bronchitis Lobar and b Lugege kogu dokumenti