产品特点
IRISH MEDICINES BOARD ACT 1995, AS AMENDED
MEDICINAL PRODUCTS (CONTROL OF PLACING ON THE MARKET) REGULATIONS, 2007, AS AMENDED
PA0361/030/002
Case No: 2042214
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
MARTINDALE PHARMACEUTICALS LTD
BAMPTON ROAD, HAROLD HILL, ROMFORD, RM3 8UG, UNITED KINGDOM
an authorisation, subject to the provisions of the said Regulations, in respect of the product
CEFUROXIME MARTINDALE PHARMA 1.5G POWDER FOR SOLUTION FOR INJECTION
the particulars of which are set out in 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 18/06/2010 until 17/06/2015.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 15/07/2010_
_CRN 2042214_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cefuroxime Martindale Pharma 1.5g powder for solution for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 1500 mg Cefuroxime (as 1578 mg cefuroxime Sodium).
For a full list of excipients see section 6.1
3 PHARMACEUTICAL FORM
Powder for Solution for Injection.
White to almost white powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Cefuroxime is indicated in the parenteral treatment of the following infections caused by organisms that are sensitive to
cefuroxime:
Lower respiratory tract infections: acute exacerbation of chronic bronchitis and bacterial
阅读完整的文件
产品特点 