Country: Armenia
Language: English
Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
fluconazole
Incepta Pharmaceuticals Limited
J02AC01
fluconazole
50mg
capsules
(30/3x10/) blisters
Prescription
Registered
2015-04-22
а{" The ýчшmеrу of the рrоduсt characteristics (Appendix 1,9) 1. Nаше of the drug 2. Qualitative composition 3. Quantitative composition : Each Capsule Fluconazole-INTA 50 contains: Active ingredient: Fluconazole 50mg Еасh Capsule Fluconazole-INTA 150 contains: Active ingredient: Fluconazole 150ш9 Fоr list of excipients, pleise see section 7,1, : Flцconazole-Inta 50 Fluconazole-Inta 150 ýPECIFICATION ITEM DESCRIPTION Active I ВР-2003, Vol-l, Page,389-392 ВР-2003, Vol-l, Р age,541 -548 ВР- 2003, Vо1-2, Page-1704-1705 USNF-22, Page,2928 Colloidal Silicon Dioxide ВР-2003, v o1-2, Page- l |'l 3,1 4 Hard Gelatin Capsule Sheý,#3, 4. Dosage fоrm : Ншd Gelatin Capsule '.4+{qt {rпэр.ri€ INCEPTA PHARMACEUTICALS LTD. DHAKA, BANGLADESH 5. Clinical characteristics : 5.1 Indications : Fluconazole is indicated for the treatment of: 1. Vaginal Candidiasis (vaginal yeast infections due to Candida). 2. Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole was also effective for the treatment of Candida urinary'tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia. 3. Cryptococcal meningitis. Before prescribing fluconazole fоr AIDS patients with cryptococcal meningitis, please see CLINICAL STUDIES. Stцdies comparing fluconazole to amphotericin В in поп-НIV infected patients have not been conducted. ,., Prophylaxis., Fluconazole is also indicated to decrease the incidence of candidiasis in patients undergoing Ьопе wmаrrоw transplantation who receive cytotoxic chemotherapy and/or radiation therapy. Specimens fоr fungal culture and other relevant laboratory studies (serology, histopathology) should Ье obtained рriоr to thеrару to isolate and identify causative organisms. Тhеrару may Ье instituted Ьеfоrе the results of the cultures and other lаЬоrаtоrу studies are known; however, once these results Ьесоmе available Read the complete document