国家: 印度尼西亚
语言: 印度尼西亚文
来源: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
ELBASVIR; GRAZOPREVIR HYDRATE
MERCK SHARP & DOHME PHARMA - Indonesia
ELBASVIR; GRAZOPREVIR HYDRATE
50/100 MG
TABLET SALUT SELAPUT
DUS, 2 AMPLOP @ 2 BLISTER @ 7 TABLET SALUT SELAPUT
SCHERING PLOUGH LABO N.V. - Belgium
2017-11-03
ZEPATIER (ELBASVIR AND GRAZOPREVIR) FILM-COATED TABLET 1. INDICATIONS AND USAGE ZEPATIER is indicated for the treatment of chronic hepatitis C (CHC) genotypes 1 (1a and 1b) infection in adults. 2. DOSAGE AND ADMINISTRATION 2.1 GENERAL ZEPATIER is a two-drug, fixed-dose combination product containing 50 mg of elbasvir and 100 mg of grazoprevir in a single tablet. The recommended dosage of ZEPATIER is one tablet taken orally once daily with or without food. 2.2 ADULTS Treatment Regimen and Duration of Therapy Table 1 below provides the recommended ZEPATIER treatment regimen and duration based on the patient population and genotype in hepatitis C virus (HCV) mono-infected and HCV/HIV-1 co-infected patients with or without cirrhosis. DISETUJUI OLEH BPOM : 08/06/2021 ID : EREG100373VR12100077 TABLE 1: RECOMMENDED DOSAGE REGIMENS AND DURATIONS FOR ZEPATIER FOR TREATMENT OF CHRONIC HEPATITIS C INFECTION IN PATIENTS WITH OR WITHOUT CIRRHOSIS TREATMENT* DURATION TREATMENT-NAÏVE OR TREATMENT-EXPERIENCED † RELAPSERS - GENOTYPE 1A OR 1B ZEPATIER 12 weeks TREATMENT-EXPERIENCED † ON-TREATMENT VIROLOGIC FAILURES ¶ - GENOTYPE 1A OR 1B Genotype 1b ZEPATIER 12 weeks Genotype 1a ZEPATIER with ribavirin #,Þ 16 weeks *Refer to the prescribing information of the medicinal products that are used in combination with ZEPATIER for specific dosing instructions. † Genotype 1a or 1b patients who have failed treatment with peginterferon alfa + ribavirin or genotype 1 patients who failed peginterferon alfa + ribavirin + boceprevir, simeprevir, or telaprevir. ¶ On-treatment virologic failures are patients who have had a null response, partial response, virologic breakthrough or rebound, or intolerance to prior treatment. # In clinical trials, the dose of ribavirin was weight-based (<66 kg = 800 mg/day, 66 to 80 kg = 1000 mg/day, 81 to 105 kg = 1200 mg/day, >105 kg = 1400 mg/day) administered in two divided doses with food. For further information on ribavirin dosing and dose modifications, refer to the ribavirin prescribing informatio 阅读完整的文件