COLOMYCIN 500000 International Unit Pdr for Soln Inj/Inf
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
26-04-2024
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Active ingredient:
COLISTIN MESILATE SODIUM
Available from:
Forest Laboratories UK Ltd
INN (International Name):
COLISTIN MESILATE SODIUM
Dosage:
500000 International Unit
Pharmaceutical form:
Pdr for Soln Inj/Inf
Prescription type:
Product subject to prescription which may not be renewed (A)
Authorization status:
Withdrawn
Authorization date:
2009-07-31
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)
PA0100/001/007
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
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