País: Irlanda
Idioma: anglès
Font: HPRA (Health Products Regulatory Authority)
DITHRANOL
Bioglan Laboratories Ltd
1%w/w %w/w
Cream
1995-11-13
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Micanol 1% Cream 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Dithranol 10mg/g cream (1%w/w). For excipients see section 6.1 3 PHARMACEUTICAL FORM Cream. Smooth and yellow in colour. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the topical treatment of sub-acute and chronic psoriasis, by the short contact therapy method. 4.2 POSOLOGY AND METHOD OF ADMINSTRATION Cutaneous Use Recommended Dosage Schedules ADULTS INCLUDING THE ELDERLY Apply Micanol cream only to the affected areas being careful to avoid contact with normal skin. Use only a small amount, rubbing it in gently and thoroughly until it no longer smears. Micanol cream should be applied once every 24 hours and removed by washing off usually no more than 30 minutes after application. The cream must be washed off using plenty of lukewarm water only. This may be easiest in a bath or shower, particularly if the treated area is extensive. When removing the cream, it is important that the water is not too hot and soap is not used, as these can damage the Micanol cream base and cause increased staining of the skin. Soap may be used for washing after the Micanol cream has been rinsed off. The treatment should start with 1% cream on a limited surface. Where the response to dithranol has not been previously established contact with 1% cream should initially be not greater than 10 minutes. This may gradually be increased to 30 minutes over a period of about seven days depending on the individual response. Missed Application: Apply as soon as you remember but not near the time for next dose. Do not apply two doses simultaneously. After 1-2 weeks patients may progress to Micanol Llegiu el document complet