Pays: Irlande
Langue: anglais
Source: HPRA (Health Products Regulatory Authority)
FLUCLOXACILLIN SODIUM
Norton Healthcare Limited T/A IVAX Pharmaceuticals UK
FLUCLOXACILLIN SODIUM
125 MG/5ml
Oral Solution
Product subject to prescription which may not be renewed (A)
Withdrawn
2012-04-26
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0282/041/003 Case No: 2061679 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to NORTON HEALTHCARE LIMITED T/A IVAX PHARMACEUTICALS UK REGENT HOUSE, 5-7 BROADHURST GARDENS, SWISS COTTAGES, LONDON NW6 3RZ, UNITED KINGDOM an authorisation, subject to the provisions of the said Regulations, in respect of the product FLUCLOXACILLIN ORAL SOLUTION BP 125 MG/5 ML 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 19/02/2009. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 19/02/2009_ _CRN 2061679_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Flucloxacillin Oral Solution BP 125 mg/5 ml. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION When reconstituted as directed, e ach 5 ml contains 125 mg flucloxacillin, as flucloxacillin sodium. Excipients: Each 5ml contains 3093.65 mg of Sucrose. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder for oral solution. A pink, pineapple-flavoured granular powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the treatment of infections due to penicillinase producing staphylococci and other gram-positive organisms susceptible Lire le document complet