Quốc gia: Ai-len
Ngôn ngữ: Tiếng Anh
Nguồn: HPRA (Health Products Regulatory Authority)
CEFUROXIME SODIUM
Martindale Pharmaceuticals Ltd
750 Base Milligrams
Pdr for Soln for Injection
2010-06-18
IRISH MEDICINES BOARD ACT 1995, AS AMENDED MEDICINAL PRODUCTS (CONTROL OF PLACING ON THE MARKET) REGULATIONS, 2007, AS AMENDED PA0361/030/001 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 750MG 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 750mg powder for solution for Injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 750 mg Cefuroxime (as 789 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 Đọc toàn bộ tài liệu