CLAFORAN Pdr for Soln for Injection 2 Grams
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
23-04-2024
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Active ingredient:
CEFOTAXIME SODIUM
Available from:
Sanofi-Aventis Ireland Limited
Dosage:
2 Grams
Pharmaceutical form:
Pdr for Soln for Injection
Authorization date:
2009-01-09
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)
PA0540/037/004
Case No: 2059853
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
Transferred from PA0006/024/004.
SANOFI-AVENTIS IRELAND LIMITED
CITYWEST BUSINESS CAMPUS, DUBLIN 24, IRELAND
an authorisation, subject to the provisions of the said Regulations, in respect of the product
CLAFORAN POWDER FOR SOLUTION FOR INJECTION 2 G
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 09/01/2009 until 17/12/2009.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 14/01/2009_
_CRN 2059853_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Claforan Powder for solution for Injection 2 g
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains cefotaxime sodium equivalent to 2g cefotaxime base.
Each gram of Claforan contains approximately 48 mg (2.09 mmol) of sodium.
For excipients, see 6.1.
3 PHARMACEUTICAL FORM
Powder for solution for injection or infusion.
A white to pale yellow-white crystalline powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
PROPERTIES: Claforan is a broad-spectrum bactericidal cephalosporin antibiotic. Claforan is exceptionally active _in_
_vitro _against Gram-n
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