TREVIVE TABLET 400MG

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

IMATINIB MESYLATE

Boleh didapati daripada:

DUOPHARMA (M) SDN. BHD.

INN (Nama Antarabangsa):

IMATINIB MESYLATE

Unit dalam pakej:

30 Tablets

Dikeluarkan oleh:

DUOPHARMA HAPI SDN. BHD.

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
1
TREVIVE TABLET
Imatinib Mesylate (100mg, 400mg)
WHAT IS IN THE LEAFLET
1.
What
_Trevive_
is used for
2.
How
_Trevive _
works
3.
Before you use
_Trevive_
4.
How to use
_Trevive_
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
_Trevive_
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of Revision
WHAT _TREVIVE_ IS USED FOR
_Trevive_
is a treatment for adults and
children for:
•
CHRONIC
MYELOID
LEUKAEMIA
(CML).
Leukaemia is a cancer of
white
blood
cells.
These
white
cells usually help the body to fight
infection.
Chronic
myeloid
leukaemia is a form of leukaemia
in which certain abnormal white
cells (named myeloid cells) start
growing out of control.
In
adult
patients,
_Trevive_
is
intended
for
use
in
the
most
advanced
phase
of
the
disease
(blast
crisis).
In
children
and
adolescents,
_Trevive_
can be used
in different phases of the disease
(chronic, accelerated phase and
blast crisis).
•
PHILADELPHIA
CHROMOSOME
POSITIVE
ACUTELYMPHOBLASTIC
LEUKAEMIA
(PH-POSITIVE
ALL).
Leukaemia is a cancer of white
blood
cells.
These
white
cells
usually
help
the
body
to
fight
infection.
Acute
lymphoblastic
leukaemia is a form of leukaemia
in which certain abnormal white
cells (named lymphoblasts) start
growing out of control.
_Trevive_
inhibits the growth of these cells.
_Trevive _
is a treatment for adults for:
•
MYELODYSPLASTIC/MYELOPROLIFER
ATIVE
DISEASES
(MDS/MPD).
These
are
a
group
of
blood
diseases
in
which
some
blood
cells start growing out of control.
_Trevive_
inhibits
the
growth
of
these cells in a certain subtype of
these diseases.
•
HYPEREOSINOPHILIC
SYNDROME
(HES)
AND/OR
CHRONICEOSINOPHILIC
LEUKAEMIA
(CEL).
These are blood diseases
in which some blood cells (named
eosinophils) start growing out of
control.
_Trevive_
inhibits
the
growth of these cells in a certain
subtype of these diseases.
•
GASTROINTESTINAL
STROMAL
TUMOURS
(GIST).
GIST
is
a
cancer
of
the
stomach
and
bowels.
It
arises
from
uncontrolled cell g

Ciri produk

[DUOPHARMA (M) SDN BHD]
TREVIVE TABLETS
IMATINIB MESYLATE TABLETS
DESCRIPTION:
TREVIVE TABLETS 100 MG: Brownish, round, biconex, film coated tablets
debossed with "100" on one side, and score line on the other side with
"C" on one side of the score line and "I" on the other
side of the score line.
TREVIVE TABLETS 400 MG: Brownish, oval, biconvex, film coated tablets
debossed with "400" on one side and "CI" on the other side.
COMPOSITION:
TREVIVE TABLETS 100 MG: Each film-coated tablet contains imatinib
mesylate equivalent to imatinib 100 mg
TREVIVE TABLETS 400 MG: Each film-coated tablet contains imatinib
mesylate equivalent to imatinib 400 mg
PHARMACODYNAMICS:
Pharmacotherapeutic group: protein-tyrosine kinase inhibitor, ATC
code: L01XE01
Mechanism of action
Imatinib is a small molecule protein-tyrosine kinase inhibitor that
potently inhibits the activity of the Bcr-Abl tyrosine kinase (TK), as
well as several receptor TKs: Kit, the receptor for stem cell
factor (SCF) coded for by the c-Kit proto-oncogene, the discoidin
domain receptors (DDR1 and DDR2), the colony stimulating factor
receptor (CSF-1R) and the platelet-derived growth factor
receptors alpha and beta (PDGFR-alpha and PDGFR-beta). Imatinib can
also inhibit cellular events mediated by activation of these receptor
kinases.
Pharmacodynamics effects
Imatinib is a protein-tyrosine kinase inhibitor which potently
inhibits the Bcr-Abl tyrosine kinase at the in vitro, cellular and in
vivo levels. The compound selectively inhibits proliferation and
induces apoptosis in Bcr-Abl positive cell lines as well as fresh
leukaemic cells from Philadelphia chromosome positive CML and acute
lymphoblastic leukaemia (ALL) patients. In colony
transformation assays using ex vivo peripheral blood and bone marrow
samples, Imatinib shows selective inhibition of BCR-ABL positive
colonies from CML patients.
_In vivo_ the compound shows anti-tumour activity as a single agent in
animal models using BcrAbl positive tumour cells.
Imatinib is also an inhibitor of the receptor tyrosin