COLOMYCIN UNITS/5ML
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
25-04-2024
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Active ingredient:
COLISTIN SULFATE
Available from:
Forest Laboratories UK Ltd
Dosage:
250,000 Units/ml
Pharmaceutical form:
Syrup
Authorization date:
1977-04-01
Summary of Product characteristics
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
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