Država: Irska
Jezik: angleščina
Source: HPRA (Health Products Regulatory Authority)
DITHRANOL
Stiefel Laboratories (U.K.) Ltd.
DITHRANOL
0.4 %w/w
Ointment
Withdrawn
2009-05-08
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Anthranol 0.4% 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Dithranol 0.40% w/w. For excipients, see 6.1. 3 PHARMACEUTICAL FORM Ointment Waxy, yellow homogeneous ointment free from particles. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Anthranol 0.4% is indicated for the topical treatment of sub-acute and chronic psoriasis, including psoriasis of the scalp. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Anthranol 0.4% is one of a range of dithranol products which include 1.0, and 2.0 ointments. Treatment should begin with Anthranol 0.4%. Clinical response and tolerance will determine the necessity for progression to Anthranol 1.0 Ointment and subsequently Anthranol 2.0 Ointment. Apply the ointment once daily, sparingly to the psoriatic plaque. Surrounding normal skin should be protected with white soft paraffin. Leave the ointment on for the required time then remove excess ointment with a paper tissue and wash off the remainder thoroughly. If Anthranol 0.4% has been applied to the scalp, the ointment should be removed by shampooing. The initial daily treatment time with each strength should not exceed 10 minutes. The time may be increased gradually over a period of 7 days to a maximum of 30 minutes. The daily treatment time should not normally exceed 30 minutes. In the event of undue irritation, stop treatment for 2 days and resume on alternate days. Treatment should be continued at the optimum tolerated strength and leave-on time, depending on patient response. Anthranol 0.4% can also be used for treatment of scalp psoriasis by the overnight method. 4.3 CONTRAINDICATIONS Anthranol 0.4% is contra-indicated in pustular psoriasis and is not suitable for the treatment of acute psoriasis. It should no Preberite celoten dokument