Land: Irland
Sprog: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
AZTREONAM
Bristol-Myers Squibb Pharmaceuticals Ltd
500 Milligram
Pdr for Soln Inj/Inf
1985-03-05
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0002/052/001 Case No: 2049681 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to BRISTOL-MYERS SQUIBB PHARMACEUTICALS LTD SWORDS, CO. DUBLIN, IRELAND an authorisation, subject to the provisions of the said Regulations, in respect of the product AZACTAM 500 MG POWDER FOR SOLUTION FOR INJECTION OR INFUSION, VIAL 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 11/08/2008 until 04/03/2010. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 29/09/2008_ _CRN 2049681_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Azactam 500 mg Powder for Solution for Injection or Infusion, vial 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 500 mg aztreonam. For excipients, see 6.1. 3 PHARMACEUTICAL FORM Powder for solution for injection or infusion A sterile white to off-white, sodium-free powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS The treatment of the following infections caused by susceptible aerobic Gram-negative micro-organisms: Urinary tract infections: Including pyelonephritis and cystitis (initial and recurrent) and asymptomatic bacteriuria, including those due to pat Læs hele dokumentet