SOVALDI TABLET 400MG

国家: 新加坡

语言: 英文

来源: HSA (Health Sciences Authority)

有效成分:

Sofosbuvir

可用日期:

GILEAD SCIENCES SINGAPORE PTE. LTD.

ATC代码:

J05AX15

药物剂型:

TABLET, FILM COATED

组成:

Sofosbuvir 400.0mg

给药途径:

ORAL

处方类型:

Prescription Only

厂商:

Patheon, Inc.

授权状态:

ACTIVE

授权日期:

2015-04-10

产品特点

1
SOVALDI
®
(SOFOSBUVIR) TABLETS
RX ONLY
1.
NAME OF THE MEDICINAL PRODUCT
Sovaldi 400 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 400 mg of sofosbuvir.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Yellow, capsule-shaped, film-coated tablet of dimensions 20 mm x 9 mm,
debossed on one side with
“GSI” and “7977” on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Sovaldi is indicated in combination with other medicinal products for
the treatment of chronic
hepatitis C (CHC) in adults (see sections 4.2, 4.4 and 5.1).
For hepatitis C virus (HCV) genotype specific activity, see sections
4.4 and 5.1.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Sovaldi treatment should be initiated and monitored by a physician
experienced in the management of
patients with CHC.
Posology
The recommended dose is one 400 mg tablet, taken orally, once daily
with food (see section 5.2).
Sovaldi should be used in combination with other medicinal products.
Monotherapy of Sovaldi is not
recommended (see section 5.1). Refer also to the package insert of the
medicinal products that are
used in combination with Sovaldi. The recommended co-administered
medicinal product(s) and
treatment duration for Sovaldi combination therapy are provided in
Table 1.
2
TABLE 1: RECOMMENDED CO-ADMINISTERED MEDICINAL PRODUCT(S) AND
TREATMENT DURATION FOR SOVALDI
COMBINATION THERAPY
PATIENT POPULATION*
TREATMENT
DURATION
Patients with
genotype 1, 4 CHC
Sovaldi +
ribavirin + peginterferon alfa
12 weeks
a, b
Patients with
genotype 2 CHC
Sovaldi + ribavirin
12 weeks
Patients with
genotype 3 CHC
Sovaldi +
ribavirin + peginterferon alfa
12 weeks
b
Sovaldi + ribavirin
24 weeks
Patients with
genotype 1, 2, 3 or 4
CHC awaiting liver
transplantation
Sovaldi + ribavirin
Until liver
transplantation
c
* Includes patients co-infected with human immunodeficiency virus
(HIV).
_a. For previously treated patients with HCV genotype 1 infection, no
data exist