Страна: Індонезія
мова: індонезійська
Джерело: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
SOFOSBUVIR; VELPATASVIR
SOHO INDUSTRI PHARMASI - Indonesia
SOFOSBUVIR; VELPATASVIR
400/100 MG
TABLET SALUT SELAPUT
DUS, 1 BOTOL PLASTIK @ 28 TABLET SALUT SELAPUT
GILEAD SCIENCES IRELAND - Ireland
2019-04-05
_p._1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF MEDICINAL PRODUCT _1.1_ _PRODUCT NAME_ EPCLUSA ® Sofosbuvir/velpatasvir _1.2_ _STRENGTH_ 400 mg sofosbuvir and 100 mg velpatasvir. _1.3_ _PHARMACEUTICAL DOSAGE FORM_ Film-coated tablet (tablet). 2. QUALITY AND QUANTITATIVE COMPOSITION _2.1_ _QUALITATIVE DECLARATION_ Sofosbuvir/velpatasvir _2.2_ _QUANTITATIVE DECLARATION_ Each film-coated tablet contains 400 mg of sofosbuvir and 100 mg of velpatasvir. 3. PHARMACEUTICAL FORM Each EPCLUSA tablet contains 400 mg of sofosbuvir and 100 mg of velpatasvir. The tablets are red, diamond-shaped, film-coated, and debossed with “GSI” on one side and “7916” on the other side. 4. CLINICAL PARTICULARS _4.1_ _THERAPEUTIC INDICATION_ Epclusa is indicated for the treatment of chronic hepatitis C (CHC) infection genotype 1, 2, 3, and 4 in adults. Efficacy of EPCLUSA for genotype 5 and 6 were based on ASTRAL-1 study conducted in 35 subjects (genotype 5) and 41 subjects (genotype 6) (see sections 4.2, 4.4 and 5.1). _4.2_ _POSOLOGY AND METHOD OF ADMINISTRATION_ Epclusa treatment should be initiated and monitored by a physician experienced in the management of patients with HCV infection. Posology The recommended dose of Epclusa is one tablet, taken orally, once daily with or without food (see section 5.2). DISETUJUI OLEH BPOM: 27/04/2022 EREG10006112000252 _p._2 TABLE 1: RECOMMENDED TREATMENT AND DURATION FOR HCV GENOTYPE 1, 2, 3 OR 4. PATIENT POPULATIONS A TREATMENT AND DURATION Patients without cirrhosis and patients with compensated cirrhosis Epclusa for 12 weeks Addition of ribavirin may be considered for genotype 3 infected patients with compensated cirrhosis (see section 5.1.) Patients with decompensated (Child-Pugh-Turcotte [CPT] Class B cirrhosis) cirrhosis Epclusa + ribavirin for 12 weeks a. Includes patients co-infected with human immunodeficiency virus (HIV) (see section 4.4.)_._ When used in combination with ribavirin, refer also to the Summary of Product Characteristics of the medicinal product containing ribavir Прочитайте повний документ