Pays: Arménie
Langue: anglais
Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
ketoconazole
Arpimed LLC
D01AC08
ketoconazole
20mg/g
cream for external use
15g aluminium tube, 25g aluminium tube
OTC
Registered
2016-07-11
SUMMARY PRODUCT CHARACTERISTIC (SPC) KETOCONAZOLE 2% CREAM FOR EXTERNAL USE 1. NAME OF THE MEDICINAL PRODUCT 1.1 TRADE NAME – Ketoconazole 1.2 INTERNATIONAL NON-PROPERTY NAME – Ketoconazole 2. CUALITATIVE AND QUANTITATIVE COMPOSITION Each gram contains: _ _ _ACTIVE INGREDIENT:_ ketoconazole - 20 mg; _FOR A FULL LIST OF EXCIPIENTS, see section 6.1._ _ _ 3. PHARMACEUTICAL FORM Cream for external use 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For topical application in the treatment of dermatophyte infections of the skin such as tinea corporis, tinea cruris, tinea manus and tinea pedis infections due to Trichophyton spp, Microsporon spp and Epidermophyton spp. Ketokonazole 2% cream is also indicated for the treatment of cutaneous candidosis (including vulvitis), tinea (pityriasis) versicolor and seborrhoeic dermatitis caused by Malassezia (previously called Pityrosporum) spp. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Ketoconazole cream is for use in adults. TINEA PEDIS: Ketoconazole 2% cream should be applied to the affected areas twice daily. The usual duration of treatment for mild infections is 1 week. For more severe or extensive infections (eg involving the sole or sides of the feet) treatment should be continued until a few days after all signs and symptoms have disappeared in order to prevent relapse. FOR OTHER INFECTIONS: Ketoconazole 2% cream should be applied to the affected areas once or twice daily, depending on the severity of the infection. The treatment should be continued until a few days after the disappearance of all signs and symptoms. The usual duration of treatment is: tinea versicolor 2–3 weeks, tinea corporis 3–4 weeks. The diagnosis should be reconsidered if no clinical improvement is noted after 4 weeks. General measures in regard to hygiene should be observed to control sources of infection or reinfection. Seborrheic dermatitis is a chronic condition and relapse is highly likely. Method of administration: Cutaneous administration. PEDIATRICS: There are limited data on the u Lire le document complet