Страна: Ирландия
Язык: английский
Источник: HPRA (Health Products Regulatory Authority)
BLEOMYCIN SULFATE
HOSPIRA UK Ltd
15000IU/vi %v/v
Unknown
1998-09-18
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0437/038/001 Case No: 2045348 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to HOSPIRA UK LTD QUEENSWAY, ROYAL LEAMINGTON SPA, WARWICKSHIRE CV31 3RW, UNITED KINGDOM an authorisation, subject to the provisions of the said Regulations, in respect of the product BLEOMYCIN 15,000 IU POWDER FOR INJECTION 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 20/02/2008 until 17/09/2008. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 06/03/2008_ _CRN 2045348_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Bleomycin 15,000 IU Powder for Injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains bleomycin 15,000 IU (as bleomycin sulphate). For excipients, see 6.1. 3 PHARMACEUTICAL FORM Powder for solution for injection Vials containing a white to cream coloured powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Adults_ Bleomycin is usually administered intramuscularly but may be given intravenously (bolus or drip), intra-arterially, intrapleurally or intraperitoneally as a solution in physiological saline. Local injection directly Прочитать полный документ