Țară: Irlanda
Limbă: engleză
Sursă: HPRA (Health Products Regulatory Authority)
GENTAMICIN SULFATE
HOSPIRA UK Ltd
40 Mg/Ml
Solution for Injection
2004-04-20
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0437/016/008 Case No: 2045348 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to HOSPIRA UK LTD QUEENSWAY, ROYAL LEAMINGTON SPA, WARWICKSHIRE CV31 3RW, UNITED KINGDOM an authorisation, subject to the provisions of the said Regulations, in respect of the product GENTAMICIN 40 MG/ML INJECTION 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 20/02/2008 until 19/04/2009. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 06/03/2008_ _CRN 2045348_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Gentamicin 40 mg/ml Injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Gentamicin Sulphate equivalent to gentamicin base 40.0 mg/ml. For excipients, see 6.1. 3 PHARMACEUTICAL FORM Solution for Injection 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Gentamicin is indicated in the treatment of serious systemic infections, including those of the central nervous system, due to organisms sensitive to this anti-infective. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Gentamicin is normally given by the intramuscular route, but can be given intravenously when intramuscular administration is not feasible, Citiți documentul complet