AZACTAM Pdr for Soln Inj/Inf 500 Milligram
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
25-04-2024
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Active ingredient:
AZTREONAM
Available from:
Bristol-Myers Squibb Pharmaceuticals Ltd
Dosage:
500 Milligram
Pharmaceutical form:
Pdr for Soln Inj/Inf
Authorization date:
1985-03-05
Summary of Product characteristics
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
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