VOTRIENT TABLET SALUT SELAPUT 200 MG

Negara: Indonesia

Bahasa: Bahasa Indonesia

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

Bahan aktif:

PAZOPANIB

Tersedia dari:

NOVARTIS INDONESIA - Indonesia

INN (Nama Internasional):

PAZOPANIB

Dosis:

200 MG

Bentuk farmasi:

TABLET SALUT SELAPUT

Unit dalam paket:

DUS, BOTOL PLASTIK @ 30 TABLET SALUT SELAPUT

Diproduksi oleh:

GLAXO OPERATIONS UK LTD - England

Tanggal Otorisasi:

2016-03-30

Karakteristik produk

_Page 1 of 20 _
VOTRIENT
TM
PAZOPANIB
QUALITATIVE AND QUANTITATIVE COMPOSITION
_200 MG TABLET _
The 200 mg tablets contain 217 mg of pazopanib hydrochloride,
equivalent to 200 mg of
pazopanib free base. Modified capsule-shaped, pink; with GS JT
debossed on one side.
_400 MG TABLET _
The 400 mg tablets contain 433 mg of pazopanib hydrochloride,
equivalent to 400 mg of
pazopanib free base. Modified capsule-shaped, white; with GS UHL
debossed on one side.
PHARMACEUTICAL FORM
Film-coated tablets
CLINICAL INFORMATION
INDICATIONS
_Renal cell carcinoma (RCC) _
Votrient is indicated for the treatment of patient with advanced Renal
Cell Carcinoma (RCC).
_Soft tissue sarcoma (STS) _
Votrient is indicated for the treatment of patients with Soft Tissue
Sarcoma (STS) who have
received prior chemotherapy.
The Phase III trial population excluded patients with gastrointestinal
stromal tumour (GIST) or
adipocytic STS.
DOSAGE AND ADMINISTRATION
Votrient treatment should only be initiated by a physician experienced
in the administration of
anti-cancer agents.
The recommended dose of Votrient for the treatment of RCC or STS is
800 mg orally once
daily.
Votrient should be taken without food (at least one hour before or 2
hours after meal) (
_see _
_Pharmacokinetics_
).
Votrient
should
be
taken
whole
with
water
and
must
not
be
broken
or
crushed
(
_see _
_Pharmacokinetics_
).
If a dose is missed, it should not be taken if it is less than 12
hours until the next dose.
DISETUJUI OLEH BPOM: 09/07/2021
EREG100005VR12100107
EREG100005VR12100108
_Page 2 of 20 _
DOSE MODIFICATIONS_ _
Dose modification, either an increase or decrease in dose, should be
in 200 mg increments in a
stepwise fashion based on individual tolerability in order to manage
adverse reactions. The dose
of Votrient should not exceed 800 mg.
RENAL IMPAIRMENT
There is no experience of Votrient in patients with severe renal
impairment or in patients
undergoing peritoneal dialysis or haemodialysis; therefore, use of
Votrient is not recommended
in these patients. Renal impairmen