ENTYVIO

Land: Indónesía

Tungumál: indónesíska

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

Virkt innihaldsefni:

VEDOLIZUMAB

Fáanlegur frá:

TAKEDA INDONESIA - Indonesia

INN (Alþjóðlegt nafn):

VEDOLIZUMAB

Skammtar:

300 MG/5 ML

Lyfjaform:

SERBUK INJEKSI

Einingar í pakka:

DUS, 1 VIAL @ 300 MG

Framleitt af:

HOSPIRA, Inc - USA

Leyfisdagur:

2019-02-28

Vara einkenni

1.
NAME OF THE MEDICINAL PRODUCT
ENTYVIO
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 300 mg of vedolizumab.
After reconstitution, each mL contains 60 mg of vedolizumab.
For excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
White to off-white lyophilized cake or powder for solution for
infusion
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_ULCERATIVE COLITIS_
Vedolizumab is indicated for the treatment of adult patients with
moderately to severely active ulcerative
colitis who have had an inadequate response with, lost response to, or
were intolerant to either
conventional therapy or a tumor necrosis factor-alpha (TNFα)
antagonist.
_CROHN’S DISEASE_
Vedolizumab is indicated for the treatment of adult patients with
moderately to severely active Crohn’s
disease who have had an inadequate response with, lost response to, or
were intolerant to either
conventional therapy or a tumor necrosis factor-alpha (TNFα)
antagonist.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
DOSAGE
_ULCERATIVE COLITIS_
The recommended dose regimen of vedolizumab is 300 mg administered by
intravenous infusion at zero,
two and six weeks and then every eight weeks thereafter. Therapy for
patients with ulcerative
colitis
should be discontinued if no evidence of therapeutic benefit is
observed by Week 14 _(see_
_ _
_section 5.1)_.
Some patients who have experienced a decrease in their response may
benefit from an
increase in dosing
frequency to vedolizumab 300 mg every four weeks.
In patients wh
o have responded to treatment with vedolizumab, corticosteroids may be
reduced and/or
discontinued in accordance with standard of care.
Page 1 of 20
DISETUJUI OLEH BPOM 7 APRIL 2021
NO AJU : EREG10023512100017
_CROHN’S DISEASE_
The recommended dose regimen of vedolizumab is 300 mg administered by
intravenous infusion at zero,
two and six weeks and then every eight weeks thereafter. Patients with
Crohn’s disease, who have not
shown a response may benefit from a dose of vedolizumab 300 mg at Week
10. Continue therapy every
ei