Zepatier 100mg/50mg Film-Coated Tablet

Country: Մալայզիա

language: անգլերեն

source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

active_ingredient:

Grazoprevir; Elbasvir

MAH:

MERCK SHARP & DOHME (MALAYSIA) SDN BHD

INN:

Grazoprevir; Elbasvir

units_in_package:

28 (Pack of 2x14) Tablets

manufactured_by:

MSD International GmbH

SPC

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