Country: Ireland
Bahasa: Inggeris
Sumber: HPRA (Health Products Regulatory Authority)
CLOTRIMAZOLE
Bayer PLC
1 %w/v
Cutaneous Solution
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) PA0021/004/003 Case No: 2038189 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to BAYER PLC BAYER HOUSE, STRAWBERRY HILL, NEWBURY, BERKSHIRE RG14 1JA, UNITED KINGDOM an authorisation, subject to the provisions of the said Regulations, in respect of the product CANESTEN 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 26/07/2007. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 22/09/2007_ _CRN 2038189_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Canesten Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Contains clotrimazole 1.0% w/v (equivalent to 10mg/ml). For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Cutaneous solution A clear, colourless solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS A broad spectrum antifungal for use in the topical treatment of infections due to superficial dermatophytes, Candida species and other fungi sensitive to the anti-infective: Trichomonas, Staphylococci and Bacteroides. The drug has no effect on Lactobacilli. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Canesten solution should be thinly and evenly applie Baca dokumen lengkap