Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
COLISTIN SULFATE
Forest Laboratories UK Ltd
250,000 Units/ml
Syrup
1977-04-01
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0100/001/003 Case No: 2071722 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to FOREST LABORATORIES UK LTD RIVERBRIDGE HOUSE, CROSSWAYS BUSINESS P, KENT, DA2 6SL, UNITED KINGDOM an authorisation, subject to the provisions of the said Regulations, in respect of the product COLOMYCIN SYRUP 250,000 UNITS/5ML 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 25/09/2009. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 25/09/2009_ _CRN 2071722_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Colomycin Syrup 250, 000 Units / 5ml 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5 ml of reconstituted syrup contains 250,000 units of Colistin Sulphate. Exipients: also includes sucrose 2.187g per 5ml and sodium methyl parahydroxybenzoate (E219) 3.125mg per 5ml For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Powder for syrup Amber glass bottles containing a cream/white powder for syrup which on reconstitution with 58 ml of water forms a syrup of volume 80 ml. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the treatment of gastrointestinal infections caused by Read the complete document