TASIGNA

Država: Indonezija

Jezik: indonezijščina

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

Enote v paketu:

DUS, 7 BLISTER @ 4 KAPSUL

Datum dovoljenje:

2022-06-04

Lastnosti izdelka

TASIGNA
®
(NILOTINIB)
200 mg hard capsules
LEAFLET
DISETUJUI OLEH BPOM: 22/03/2021
ID: EREG10000512000230
TRADENAME
200 MG HARD CAPSULES
TASIGNA
®
200 mg hard capsules
DESCRIPTION AND COMPOSITION
PHARMACEUTICAL FORM
Hard capsules
200 MG HARD CAPSULES
White to slightly yellowish powder in light yellow opaque hard gelatin
capsules, size 0 with
red axial imprint “NVR/TKI”.
ACTIVE SUBSTANCE
200 MG HARD CAPSULES
Each capsule contains 200 mg nilotinib base (as hydrochloride,
monohydrate).
EXCIPIENTS
200 MG HARD CAPSULES
Capsule
content:
Lactose
monohydrate;
Crospovidone;
Poloxamer
188;
Silica
colloidal,
anhydrous/Colloidal silicon dioxide; Magnesium stearate.
Capsule shell: Gelatin; Titanium dioxide (E 171); Iron oxide, yellow
(E 172).
Printing ink:
Iron oxide, red (E 172).
INDICATIONS
TASIGNA hard capsule is indicated for the treatment of chronic phase
and accelerated phase
Philadelphia chromosome positive chronic myelogenous leukaemia (CML)
in adult patients
resistant to or intolerant to at least one prior therapy including
imatinib. Ph+ CML patients in
chronic phase, who have been previously treated with imatinib and
whose treatment has been
switched to TASIGNA for at least 3 years and have achieved a sustained
deep molecular
response may be eligible for treatment discontinuation (see sections
Dosage regimen and
administration and Clinical studies).
DOSAGE REGIMEN AND ADMINISTRATION
Therapy with TASIGNA should be initiated by a physician experienced in
the treatment of
patients with CML.
DISETUJUI OLEH BPOM: 22/03/2021
ID: EREG10000512000230
TASIGNA
may
be
given
in
combination
with
haematopoietic
growth
factors
such
as
erythropoietin
or
granulocyte
colony-stimulating
factor
(G-CSF)
if
clinically
indicated.
TASIGNA may be given with hydroxyurea or anagrelide if clinically
indicated.
Monitoring of response to Tasigna therapy in Ph+ CML patients should
be performed both
routinely and when therapy is modified, to identify suboptimal
response, loss of response to
therapy, poor patient compliance, or possible drug-d