Nazione: Irlanda
Lingua: inglese
Fonte: HPRA (Health Products Regulatory Authority)
COLISTIN MESILATE SODIUM
Forest Laboratories UK Ltd
COLISTIN MESILATE SODIUM
500000 International Unit
Pdr for Soln Inj/Inf
Product subject to prescription which may not be renewed (A)
Withdrawn
2009-07-31
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0100/001/007 Case No: 2045705 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to FOREST LABORATORIES UK LTD BOURNE ROAD, BEXLEY, KENT DA5 1NX, ENGLAND an authorisation, subject to the provisions of the said Regulations, in respect of the product COLOMYCIN INJECTION 500 000 INTERNATIONAL UNITS. POWDER FOR SOLUTION FOR INJECTION, INFUSION OR INHALATION. 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 24/02/2009. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 25/02/2009_ _CRN 2045705_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Colomycin Injection 500 000 International Units. Powder for solution for injection, infusion or inhalation. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 500,000 International Units Colistimethate Sodium. For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Powder for solution for injection, infusion or inhalation. Sterile white powder in a 10ml colourless glass vial with a blue ‘flip-off’ cap. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Colomycin is indicated in the treatment of the following infections where Leggi il documento completo