País: Indonèsia
Idioma: indonesi
Font: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
EFAVIRENZ, TENOFOVIR DISOPROXIL FUMARATE, LAMIVUDINE
KIMIA FARMA Tbk. - Indonesia
EFAVIRENZ, TENOFOVIR DISOPROXIL FUMARATE, LAMIVUDINE
400 MG /300 MG /300 MG
TABLET SALUT SELAPUT
DUS, 1 BOTOL PLASTIK @ 30 TABLET SALUT SELAPUT
MYLAN LABORATORIES LIMITED - India
2020-08-06
AVONZA TENOFOVIR DISOPROXIL FUMARATE/LAMIVUDINE/ EFAVIRENZ 300MG/300MG/400MG PT. KIMIA FARMA MYLAN LABORATORIES LTD. Summary of Product Characteristics AVONZA | 1 1. NAME OF THE MEDICINAL PRODUCT AVONZA Film Coated Tablet Tenofovir Disoproxil Fumarate/Lamivudine/Efavirenz 300 mg/300 mg/400 mg 1 1 Trade names are not prequalified by WHO. This is under local DRA responsibility. Throughout this WHOPAR the proprietary name is given as an example only. 2. PHARMACEUTICAL DOSAGE FORM Film coated tablet A white to off-white, film coated, oval, biconvex, beveled edge tablet debossed with M on one side of the tablet and TLE on the other side. 3. COMPOSITION Each film-coated tablet contains: Tenofovir Disoproxil Fumarate 300 mg Lamivudine USP 300 mg Efavirenz USP 400 mg For excipients, see section 15 4. PHARMACOLOGICAL PROPERTIES 4.1 Pharmacodynamic Properties ▪ PHARMACOTHERAPEUTIC GROUP: Antivirals for treatment of HIV infections, combinations ▪ ATC CODE: J05AR11 ▪ PHARMACOLOGICAL CLASSIFICATION: 7.13 Antivirals ▪ MECHANISM OF ACTION : Tenofovir Disoproxil Fumarate/Lamivudine/Efavirenz Film Coated Tablets 300 mg/300 mg/400 mg are a fixed dose combination of Antiviral drugs Tenofovir Disoproxil Fumarate, Lamivudine and Efavirenz 4.2 PHARMACOKINETIC PROPERTIES Tenofovir Disoproxil Fumarate/Lamivudine/Efavirenz Film Coated Tablets 300 mg/300 mg/400 mg are bioequivalent to Viread® tablets ( Tenofovir Disoproxil Fumarate Tablet), Epivir® Tablet (Lamivudine 300 mg tablet) plus two tablets of Efamat® (Efavirenz 200 mg tablet) when single doses were administered to healthy volunteers under fasting conditions. Tenofovir Disoproxil Fumarate/Lamivudine/Efavirenz Film Coated Tablets 300 mg/300 mg/400 mg has not been evaluated under fed conditions. Efavirenz and other products containing Efavirenz should be administered under fasted conditions. DISETUJUI OLEH BPOM : 17/07/2020 EREG10030311800034 AVONZA TENOFOVIR DISOPROXIL FUMARATE/LAMIVUDINE/ EFAVIRENZ 300MG/300MG/400MG PT. KIMIA FARMA MYLAN LABORATORIES LTD. Summary of Pro Llegiu el document complet