Država: Irska
Jezik: engleski
Izvor: HPRA (Health Products Regulatory Authority)
ALUMINIUM OXIDE
Stiefel Laboratories (U.K.) Ltd.
ALUMINIUM OXIDE
52 %w/w
Cutaneous Paste
Withdrawn
2009-05-08
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Brasivol No. 2 Medium 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Aluminium oxide 52.0% w/w. For excipients, see 6.1. 3 PHARMACEUTICAL FORM Cutaneous Paste A greyish-blue moderately gritty cutaneous paste with a slight perfume. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Brasivol is indicated in the treatment of acne vulgaris. Brasivol No. 2 Medium effectively cleanses and removes debris from blocked pores and removes excess sebum from the skin, thus maintaining patency of the pore duct openings. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Two grades of Brasivol are available: Brasivol No. 1 Fine and Brasivol No. 2 Medium. Treatment should normally commence with Brasivol No. 1 Fine. The abrasive cleansing paste should be applied to wetted skin and rubbed gently but firmly over the affected area with a circular motion for 15-20 seconds, then rinsed off thoroughly with water. This routine may be repeated two or three times daily, replacing ordinary soap and water. In more severe conditions, after the use of Brasivol No. 1 Fine for several weeks, the skin may require the slightly more abrasive action of Brasivol No. 2 Medium. 4.3 CONTRAINDICATIONS Brasivol is contra-indicated in the presence of superficial venules and telangiectasia (actinic sequelae). 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Care should be taken to avoid using Brasivol No. 2 Medium close to the eyes or mouth. Male patients using an electric razor should shave before applying Brasivol No. 2 Medium. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION None. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 07/12/2006 Pročitajte cijeli dokument