Land: Sør-Afrika
Språk: engelsk
Kilde: South African Health Products Regulatory Authority (SAHPRA)
Schering
TRAVOCORT CREAM SCHEDULING STATUS: S4 PROPRIETARY NAME (and dosage form): TRAVOCORT CREAM Broad-spectrum antimycotic with a corticoid additive COMPOSITION 1 g Travocort contains isoconazole nitrate (1-[2,4-dichloro-b-(2,6-dichlorobenzyloxy)-phenethyl]-imidazole, nitrate) 10 mg and diflucortolone valerate (6alpha,9-difluoro-11beta-hydroxy-21-valeryloxy-16alpha-methyl-1,4-pregna- diene- 3,20-dione) 1 mg in an easy-to-remove low fat base o/w emulsion. PHARMACOLOGICAL CLASSIFICATION A. 13.4.1 Corticosteroids with anti-infective agents. PHARMACOLOGICAL ACTION Isoconazole nitrate is for use in the treatment of superficial fungal diseases of the skin. It is effective against dermatophytes and yeasts, yeast-like fungi and moulds, as well as against the causative organism of tinea versicolor and that of erythrasma. Diflucortolone valerate suppresses inflammation in inflammatory and allergic skin conditions and alleviates the subjective complaints such as itching, burning and pain. INDICATIONS Fungal infections of hairless and hairy skin, eg in the region of the hands, the interdigital spaces of the feet, and in the inguinal and genital regions. Because of the addition of diflucortolone valerate, Travocort is indicated for the initial or intermediate treatment of those fungal diseases which are accompanied by highly inflammatory or eczematous skin conditions. CONTRA-INDICATIONS Tuberculous and syphilitic processes in the area to be treated, virus diseases (herpes simplex, vaccinia, varicella and smallpox). Potent topical corticosteroid preparations (Travocort) should not be applied to any skin crease areas. Corticosteroids have been shown to be teratogenic in animals following dermal application. As these agents are absorbed percutaneously, teratogenicity following topical application cannot be excluded. Therefore Tra Les hele dokumentet