País: Armenia
Idioma: inglés
Fuente: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
terbinafine (terbinafine hydrochloride)
Hankook Korus Pharm Co.
D01AE15
terbinafine (terbinafine hydrochloride)
10mg/g
cream for external use
aluminium tube 30g
Prescription
Registered
2020-09-05
ATC CODE D01AE15 TO BE PRESCRIBED TERBINAFINE-ASTERIA CREAM (TERBINAFIN HCL) [COMPOSITION] Each 1g cream contains: Active ingredient Terbinafine hydrochloride ……………………………….10.0mg (8.888mg as a Terbinafine) Excipients: Stearyl Alcohol, Cetyl Alcohol, Paraffin Liquid, Propylene glycol, Purified water, Sorbitan Monostearate, Polysorbate 60, Sodium hydroxide, Methyl Parahydroxybenzoate, Propyl parahydroxybenzoate. [INDICATION] The treatment of tinea pedis (athlete's foot) and tinea cruris (dhobie itch/jock itch) caused by _Trichophyton _ (e.g. _T. _ _rubrum, _ _T. _ _mentagrophytes, _ _T. _ _verrucosum, _ _T. _ _violaceum) _ _and _ _Epidermophyton floccosum_ [DOSAGE AND ADMINISTRATION] Adults and children over 16 years of age Terbinafine Hydrochloride Cream is applied once daily. Duration and frequency of treatment Duration of treatment is one week for tinea pedis and tinea cruris. Relief of clinical symptoms usually occurs within a few days. Irregular use or premature discontinuation of treatment carries the risk of recurrence. If there are no signs of improvement after two weeks, the diagnosis should be verified by a physician. Dosing in special populations: Paediatric population The experience with topical Terbinafine Hydrochloride Cream in children is still limited and its use in children under 16 years cannot therefore be recommended. Elderly patients There is no evidence to suggest that elderly patients require different dosages or experience side-effects different to those of younger patients. Method of administration For cutaneous use. The affected area should be cleaned and dried thoroughly before application of Terbinafine Hydrochloride Cream. The cream should be applied to the affected skin and surrounding area in a thin layer and rubbed in lightly. In the case of intertriginous infections (interdigital, intergluteal, inguinal) the application may be covered with a gauze strip, especially at night. [CONTRAINDICATION] Hypersensitivity to terbinafine or to any of the excipients contai Leer el documento completo
Summary of Product Characteristics Terbinafine-Asteria 1. NAME OF THE MEDICINAL PRODUCT Terbinafine-Asteria Cream 30g 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active ingredient No. Chemical Name Quantity/g Use 1 Terbinafine Hydrochloride 10.0 mg (8.888mg as Terbinafine) Active ingredient Excipient(s) No. Chemical Name Quantity/g Use 1 Stearyl Alcohol 50.0 mg Base 2 Cetyl Alcohol 50.0 mg Base 3 Paraffin Liquid 67.9 mg Base 4 Propylene Glycol 150.0 mg Base 5 Purified Water q.s Base 6 Sorbitan Monostearate 20.0 mg Emulsifier 7 Polysorbate 60 20.0 mg Emulsifier 8 Sodium Hydroxide q.s pH Adjuster 9 Methylparaben 0.5 mg preserved agent 10 Propylparaben 0.5 mg preserved agent 3. PHARMACEUTICAL FORM Cream 4. CLINICAL PARTICULARS 4.1 Therapeutic indications The treatment of tinea pedis (athlete's foot) and tinea cruris (dhobie itch/jock itch) caused by Trichophyton (e.g. T. rubrum, T. mentagrophytes, T. verrucosum, T. violaceum) and Epidermophyton floccosum. 4.2 Posology and method of administration Adults and children over 16 years of age Terbinafine Hydrochloride Cream is applied once daily. Duration and frequency of treatment Duration of treatment is one week for tinea pedis and tinea cruris. Relief of clinical symptoms usually occurs within a few days. Irregular use or premature discontinuation of treatment carries the risk of recurrence. If there are no signs of improvement after two weeks, the diagnosis should be verified by a physician. Dosing in special populations: Paediatric population The experience with topical Terbinafine Hydrochloride Cream in children is still limited and its use in children under 16 years cannot therefore be recommended. Elderly patients There is no evidence to suggest that elderly patients require different dosages or experience side-effects different to those of younger patients. Method of administration For cutaneous use. The affected area should be cleaned and dried thoroughly before application of Terbinafine Hydrochloride Cream. The cream should be applied to the affected skin and Leer el documento completo