EPCLUSA

Negara: Indonesia

Bahasa: Bahasa Indonesia

Sumber: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Bahan aktif:

SOFOSBUVIR; VELPATASVIR

Tersedia dari:

SOHO INDUSTRI PHARMASI - Indonesia

INN (Nama Internasional):

SOFOSBUVIR; VELPATASVIR

Dosis:

400/100 MG

Bentuk farmasi:

TABLET SALUT SELAPUT

Unit dalam paket:

DUS, 1 BOTOL PLASTIK @ 28 TABLET SALUT SELAPUT

Diproduksi oleh:

GILEAD SCIENCES IRELAND - Ireland

Tanggal Otorisasi:

2019-04-05

Karakteristik produk

_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