国: アイルランド
言語: 英語
ソース: HPRA (Health Products Regulatory Authority)
AMPICILLIN TRIHYDRATE
Ranbaxy Ireland Limited
250 Milligram
Capsules Hard
1985-12-12
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0408/001/001 Case No: 2037655 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to RANBAXY IRELAND LIMITED SPAFIELD, CORK ROAD, CASHEL, CO. TIPPERARY, IRELAND an authorisation, subject to the provisions of the said Regulations, in respect of the product RIMACILLIN 250 MG HARD CAPSULES 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 12/12/2005. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 29/09/2008_ _CRN 2037655_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Rimacillin 250 mg Hard Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 250 mg ampicillin (as the trihydrate). For full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Hard capsule. Size 1, hard, gelatin capsules with a scarlet body and grey cap overprinted 'RIMA 250' containing a white powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the treatment of infections due to organisms sensitive to Ampicillin. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION To be taken orally. DOSE: ADULTS AND CHILDREN OVER 20KG BODY WEIGHT: The usual dose is 250mg every six hours. For treatment of 完全なドキュメントを読む