GENOPTIC LIQUIFILM
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
11-05-2024
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Active ingredient:
GENTAMICIN SULFATE
Available from:
Allergan Pharmaceuticals Ireland
Dosage:
0.30 %w/v
Pharmaceutical form:
Eye Drops Solution
Authorization date:
1982-08-25
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)
PA0148/035/001
Case No: 2066571
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
ALLERGAN PHARMACEUTICALS IRELAND
CASTLEBAR ROAD, WESTPORT, CO. MAYO, IRELAND
an authorisation, subject to the provisions of the said Regulations, in respect of the product
GENOPTIC LIQUIFILM 0.30% W/V EYE DROPS SOLUTION
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 24/06/2009.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 24/06/2009_
_CRN 2066571_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Genoptic Liquifilm 0.30 % w/v Eye Drops Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Genoptic contains 0.30 % w/v (3mg/ml) gentamicin sulphate (as gentamicin base).
Excipients: contains 0.004 % w/v benzalkonium chloride.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Eye drops solution
Clear, colourless to slightly yellow solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the topical treatment of infections of the external portions of eye or adnexa due to organisms sensitive to
gentamicin.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Topical by instillation into con
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