GENTAMICIN INJECTION BP
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
25-04-2024
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Active ingredient:
GENTAMICIN SULFATE
Available from:
HOSPIRA UK Ltd
Dosage:
40 Mg/Ml
Pharmaceutical form:
Solution for Injection
Authorization date:
2004-04-20
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)
PA0437/016/008
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
GENTAMICIN 40 MG/ML 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 19/04/2009.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 06/03/2008_
_CRN 2045348_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Gentamicin 40 mg/ml Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Gentamicin Sulphate equivalent to gentamicin base 40.0 mg/ml.
For excipients, see 6.1.
3 PHARMACEUTICAL FORM
Solution for Injection
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Gentamicin is indicated in the treatment of serious systemic infections, including those of the central nervous system,
due to organisms sensitive to this anti-infective.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Gentamicin is normally given by the intramuscular route, but can be given intravenously when intramuscular
administration is not feasible,
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