BLEPH-10 Eye Drops Solution 10 %w/v
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
23-04-2024
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Active ingredient:
SULFACETAMIDE SODIUM
Available from:
Allergan Pharmaceuticals Ireland
Dosage:
10 %w/v
Pharmaceutical form:
Eye Drops Solution
Authorization date:
1977-04-01
Summary of Product characteristics
IRISH MEDICINES BOARD ACT 1995
MEDICINAL PRODUCTS(LICENSING AND SALE)REGULATIONS, 1998
(S.I. NO.142 OF 1998)
PA0148/022/001
Case No: 2028850
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
BLEPH-10 LIQUIFILM TOPICAL OPHTHALMIC SOLUTION 10.0 %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 01/04/2007.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 18/04/2007_
_CRN 2028850_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Bleph-10 Liquifilm Topical Ophthalmic Solution 10.0 % w/v, eye drops solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Sulfacetamide Sodium 10.0 % w/v
Excipient: Contains benzalkonium chloride 0.005% w/v
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Eye drops, solution.
A clear colourless to slightly straw coloured solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the treatment of conjunctivitis, corneal ulcer, and other superficial ocular infections from susceptible
microorganism.
As an adjunct to systemic sulfonamide therapy of trachoma.
4.2 POSOLOGY AND METHOD O
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