Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
FUSIDATE SODIUM HYDROCORTISONE ACETATE
Leo Laboratories Limited
Ointment
1977-04-01
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0046/005/003 Case No: 2049660 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to LEO LABORATORIES LIMITED CASHEL ROAD, DUBLIN 12, IRELAND an authorisation, subject to the provisions of the said Regulations, in respect of the product FUCIDIN H OINTMENT 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 13/05/2008 until 28/03/2010. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 12/06/2008_ _CRN 2049660_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Fucidin H Ointment 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Contains sodium fusidate 2% w/w and hydrocortisone acetate 1% w/w. For excipients, see 6.1. 3 PHARMACEUTICAL FORM Ointment Off-white viscous ointment. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Use in inflammatory dermatoses where bacterial infection is present or likely to occur. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Apply a small quantity to the affected area twice daily until a satisfactory response is obtained. A single treatment course should not normally exceed 2 weeks. 4.3 CONTRAINDICATIONS Use in patients hypersensitive to the active ingredients. Use in the Read the complete document