Quốc gia: Ai-len
Ngôn ngữ: Tiếng Anh
Nguồn: HPRA (Health Products Regulatory Authority)
AMOXICILLIN CLAVULANIC ACID
Clonmel Healthcare Ltd
500/125 Base Milligrams
Tablets
2001-10-19
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0126/103/005 Case No: 2076341 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to CLONMEL HEALTHCARE LIMITED WATERFORD ROAD, CLONMEL, CO. TIPPERARY, IRELAND an authorisation, subject to the provisions of the said Regulations, in respect of the product CLAVAMEL FORTE 500/125 MG TABLETS 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 16/04/2010 until 12/06/2010. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 16/04/2010_ _CRN 2076341_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Clavamel Forte 500/125 mg Tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One tablet contains 500 mg amoxicillin (as amoxicillin trihydrate) and 125 mg clavulanic acid (as potassium clavulanate). For excipients, see 6.1. 3 PHARMACEUTICAL FORM Tablet. Yellowish white to light yellow oblong tablets with an embossment “625” on one side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of bacterial infections induced by Gram-negative and Gram-positive amoxicillin resistant micro-organisms when resistance is caused by beta-lactamases, which are sensitive to the combination of amoxicillin and cl Đọc toàn bộ tài liệu