BLEPHAMIDE LIQUIFILM
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
27-04-2024
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Active ingredient:
PREDNISOLONE ACETATE SULFACETAMIDE SODIUM PHENYLEPHRINE HYDROCHLORIDE
Available from:
Allergan Pharmaceuticals Ireland
Dosage:
0.22/10.3 %w/v
Pharmaceutical form:
Eye Drops Suspension
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)
PA0148/021/001
Case No: 2031031
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
BLEPHAMIDE LIQUIFILM TOPICAL OPTHALMIC SUSPENSION
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 21/12/2006 until 31/03/2007.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 22/12/2006_
_CRN 2031031_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Blephamide LiquifilmTopical Ophthalmic Suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
For excipients, see 6.1
3 PHARMACEUTICAL FORM
Eye Drops Suspension
An off-white to slightly yellow, microfine suspension.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of nonpurulent blepharitis and blepharoconjunctivitis (seborrheal, staphylococcal, allergic), and nonpurulent
conjunctivitis (allergic and bacterial).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
One drop two to four times daily, depending upon the severity of the condition.
In general, during early or acute stages of blepharitis, Blephamide produces resu
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