Страна: Армения
Язык: английский
Источник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
fluconazole
Arpimed LLC
J02AC01
fluconazole
150mg
capsules
(10/1x10/) blister
Prescription
Registered
2015-03-09
SUMMARY PRODUCT CHARACTERISTIC (SPC) FLUCONAZOLE 150 MG CAPSULES 1. NAME OF THE MEDICINAL PRODUCT Fluconazole 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule_ _of _Fluconazole _contains: _ACTIVE INGREDIENT: _fluconazole - 150 mg; _INACTIVE INGREDIENTS:_ lactose monohydrate, ethylcellulose _ _ _COMPOSITION OF EACH HARD GELATIN CAPSULE: _ _CAP AND BODY :_ Brilliant Blue FCF (E133, C.I number 42090) (BLUE Nº1), Sunset Yellow FCF (E110, C.I number 15985) (YELLOW Nº6) , Quinoline Yellow WS (E104, C.I number 47005) (YELLOW Nº10), Titannium Dioxide (Е 171, C.I number 77891), Propylene Glycol (E1520), MethylParaben (E218), PropylParaben (E216) , SLS (Е487), Acetic Acid (E260), Colloidal Silicon Dioxide (Е551), Gelatin q.s.p. 3. PHARMACEUTICAL FORM Capsules 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Fluconazole is a triazole antifungal used for treatment of vaginal candidiasis and candidal balanitis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Fluconazole is given by mouth. IN ADULT Fluconazole, 150 mg by mouth as a single dose may be used for vaginal candidiasis or candidal balanitis. IN CHILDREN Despite extensive data supporting the use of Fluconazole in children there are limited data available on the use of Fluconazole for genital candidiasis in children below 16 years. Use at present is not recommended unless antifungal treatment is imperative and no suitable alternative agent exists. ELDERLY PATIENTS do not require correction dosing regimen. 4.3 CONTRAINDICATIONS Fluconazole is contraindicated in patients with known hypersensitivity to the drug or any ingredient in the respective formulation. Coadministration of terfenadine is contraindicated in patients receiving Fluconazole at multiple doses of 400 mg per day or higher based upon results of a multiple dose interaction study. Coadministration of other medicinal products known to prolong the QT interval and which are metabolised via the cytochrome P450 (CYP) 3A4 such as cisapride, astemizole, pimozide, quinidine and erythromycin are contraindic Прочитать полный документ