Land: Irland
Sprache: Englisch
Quelle: HPRA (Health Products Regulatory Authority)
MICONAZOLE NITRATE FLUPREDNIDENE ACETATE
Crookes Healthcare Ltd
2/0.1 %w/w
Cream
1997-09-07
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Mycortin Cream 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 3 PHARMACEUTICAL FORM Cream A white to off white pliant cream. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS In the management of the acute inflammatory phase of mycotic skin infections. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For topical application in adults. The cream should be thinly applied to the affected area once or twice daily, as directed by the physician. 4.3 CONTRAINDICATIONS Use in infants under 2 years old. Use in infants in conjunction with occlusion. Use in the presence of infections of viral, tuberculous or treponemal origin, or of bacterial infections due to gram-negative organisms. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Mycortin Cream should not usually be used for longer than one week. If there is no clinical improvement after 1 week of treatment, you should contact your doctor to review the treatment. Consult your doctor before use if you have facial rosacea, acne or perioral dermatitis. In the elderly, corticosteroid containing preparations should be used sparingly and for short periods. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION None known. 4.6 PREGNANCY AND LACTATION The product should not be used during pregnancy unless considered essential by the physician. Fluprednidene acetate 0.1 % w/w Miconazole nitrate 2.0 % w/w IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 16/08/2006_ _CRN 2026814_ _page number: 1_ 4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES None known. 4.8 UNDESIRABLE EFFECTS Excessive use may result in local atrophy of the skin, striae and superficial vascular dilatation. Pro Lesen Sie das vollständige Dokument