Country: Armenja
Lingwa: Ingliż
Sors: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
fluconazole
Tufenkji Group LLC
J02AC01
fluconazole
150mg
capsules
(10/1x10/) in blister
Prescription
Registered
2017-09-05
SUMMARY OF PRODUCT CHARACTERISTICS FLUCO Fluconazole 150 mg Capsules 1. Name of the medicinal product FLUCO 2. Qualitative and quantitative composition Each capsule contains Active substance: fluconazole 150 mg Excipient(s): for the full list of excipients see Section 6.1. 3. Pharmaceutical form Hard gelatin capsule Maroon/White Opaque, hard gelatin capsule Size “2” filled with white to off white powder 4. Clinical particulars 4.1 Therapeutic indications Fluco is indicated in the following fungal infections (see section 5.1). Fluco is indicated in adults for the treatment of: Cryptococcal meningitis (see section 4.4). Coccidioidomycosis (see section 4.4). Invasive candidiasis. Mucosal candidiasis including oropharyngeal, oesophageal candidiasis, candiduria and chronic mucocutaneous candidiasis. Chronic oral atrophic candidiasis (denture sore mouth) if dental hygiene or topical treatment are insufficient. Vaginal candidiasis, acute or recurrent; when local therapy is not appropriate. Candidal balanitis when local therapy is not appropriate. Dermatomycosis including tinea pedis, tinea corporis, tinea cruris, tinea versicolor and dermal candida infections when systemic therapy is indicated. Tinea unguinium (onychomycosis) when other agents are not considered appropriate. Fluco is indicated in adults for the prophylaxis of: Relapse of cryptococcal meningitis in patients with high risk of recurrence. Relapse of oropharyngeal or oesophageal candidiasis in patients infected with HIV who are at high risk of experiencing relapse. To reduce the incidence of recurrent vaginal candidiasis (4 or more episodes a year). Prophylaxis of candidal infections in patients with prolonged neutropenia (such as patients with haematological malignancies receiving chemotherapy or patients receiving Hematopoietic Stem Cell Transplantation (see section 5.1)). Fluco is indicated in term newborn infants, infants, toddlers, children, and adolescents aged from 0 to 17 years old: Fluco is us Aqra d-dokument sħiħ