Land: Malaysia
Språk: engelska
Källa: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Grazoprevir; Elbasvir
MERCK SHARP & DOHME (MALAYSIA) SDN BHD
Grazoprevir; Elbasvir
28 (Pack of 2x14) Tablets
MSD International GmbH
LPC- MK5172A-T-022020 PRODUCT MONOGRAPH ZEPATIER ® 50 mg of elbasvir and 100 mg of grazoprevir PART I: HEALTH PROFESSIONAL INFORMATION SUMMARY PRODUCT INFORMATION Route of Administration Dosage Form / Strength Clinically Relevant Nonmedicinal Ingredients oral Tablet 50 mg elbasvir and 100 mg grazoprevir Lactose monohydrate For a complete listing see Dosage Forms, Composition and Packaging section. INDICATIONS AND CLINICAL USE ZEPATIER ® (elbasvir/grazoprevir) is indicated for the treatment of chronic hepatitis C (CHC) genotypes 1, 3, or 4 infection in adults as follows: Without ribavirin: • in genotype (GT) 1 or 4 treatment-naïve (TN) and peginterferon alfa + ribavirin (PR) treatment-experienced (TE) relapsers (12 weeks) • in GT1 protease inhibitor (PI)/PR-TE relapsers (12 weeks) • in GT1b PR- or PI/PR-TE on-treatment virologic failures (12 weeks) With ribavirin: • in GT1a PR- or PI/PR-TE on-treatment virologic failures (16 weeks) • in GT4 PR-TE on-treatment virologic failures (16 weeks) With sofosbuvir: • in GT3 TN patients (12 weeks) (see DOSAGE AND ADMINISTRATION) Geriatrics (> 65 years of age): There were a limited number of geriatrics patients (N=187) included in the clinical trials. There was no overall difference in safety or efficacy observed in these patients (see WARNINGS AND PRECAUTIONS, Special Populations). Pediatrics (< 18 years of age): Safety and efficacy of ZEPATIER ® have not been established in pediatric patients less than 18 years of age. CONTRAINDICATIONS • Patients who are hypersensitive to this drug or to any ingredient in the formulation or component of the container. For a complete listing, see the Dosage Forms, Composition and Packaging section of the product monograph. • If ZEPATIER ® is administered with ribavirin or sofosbuvir, the contraindications to ribavirin or sofosbuvir also apply to this combination regimen. Refer to the ribavirin or sofosbuvir product monograph for a list of contraindications for ribavirin or sofosbuvir. • ZEPATIER ® is contraindicated Läs hela dokumentet