Χώρα: Ιρλανδία
Γλώσσα: Αγγλικά
Πηγή: HPRA (Health Products Regulatory Authority)
AMPICILLIN TRIHYDRATE
Ranbaxy Ireland Limited
250 MG/5ml
Powder for Oral Suspension
1987-11-06
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0408/001/004 Case No: 2054055 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/5 ML 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 06/11/2008. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 06/11/2008_ _CRN 2054055_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Rimacillin 250 mg/5 ml Powder for Oral Suspension 2 QUALITATIVE AND QUANTITATIVE COMPOSITION When reconstituted, each 5 ml contains 250 mg ampicillin (as the trihydrate). Each 5ml dose also includes 0.25 mg of amaranth (E123) and 2.63 g of sucrose. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder for oral suspension. Pale-pink 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. After reconstitution powder forms a pink suspension wi Διαβάστε το πλήρες έγγραφο