देश: आयरलैंड
भाषा: अंग्रेज़ी
स्रोत: HPRA (Health Products Regulatory Authority)
KETOCONAZOLE
Johnson & Johnson (Ireland) Limited
D01AC08
KETOCONAZOLE
20 mg/g
Shampoo
Product not subject to medical prescription
ketoconazole
Marketed
1999-11-26
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Nizoral Dandruff 20mg/g Shampoo 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each gram of shampoo contains 20mg of ketoconazole For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Shampoo Pink, viscous shampoo 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS In the prevention and treatment of infections in which_ Malassezia_ (previously called_ Pityrosporum_) infection may be a factor, such as seborrhoea capitis, and seborrhoeic dermatitis of the body. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Nizoral Shampoo is for use in adults and adolescents aged 12 years and over. Seborrhoea capitis Apply the shampoo to the affected scalp, leave for three minutes, then rinse. Seborrhoeic dermatitis Wash the affected areas with shampoo and leave for 3 to 5 minutes before rinsing. Treatment should be repeated twice weekly for 2 to 4 weeks. For prophylaxis use once, every 1 to 2 weeks. Method of administration Cutaneous. 4.3 CONTRAINDICATIONS Use in patients hypersensitive to any of the ingredients. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _D_ _a_ _t_ _e_ _ _ _P_ _r_ _i_ _n_ _t_ _e_ _d_ _ _ _1_ _8_ _/_ _0_ _9_ _/_ _2_ _0_ _1_ _7_ _C_ _R_ _N_ _ _ _2_ _1_ _9_ _6_ _5_ _2_ _5_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE In patients who have been on prolonged treatment with topical corticosteroids, it is recommended that the steroid therapy be gradually withdrawn over a period of 2 to 3 weeks, while using पूरा दस्तावेज़ पढ़ें