ACCORD IMATINIB 400 (Imatinib Tablets 400 mg)

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

IMATINIB MESYLATE

Boleh didapati daripada:

ACCORD HEALTHCARE SDN.BHD.

INN (Nama Antarabangsa):

IMATINIB MESYLATE

Unit dalam pakej:

3X10 Tablets

Dikeluarkan oleh:

INTAS PHARMACEUTICALS LIMITED

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
_ _
ACCORD IMATINIB TABLET
Imatinib (100mg & 400mg)
1
WHAT IS IN THIS LEAFLET
1.
What
Accord
Imatinib
tablet is used for
2.
How Accord Imatinib tablet
works
3.
Before
you
use
Accord
Imatinib tablet
4.
How
to
take
Accord
Imatinib tablet
5.
While you are using Accord
Imatinib tablet
6.
Side effects
7.
Storage
and
disposal
of
Accord Imatinib tablet
8.
Product description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT ACCORD IMATINIB IS USED
FOR
Accord Imatinib
is indicated in
treatment
of
some
types
of
cancer.
Accord Imatinib is a treatment
for
adults
and
children
and
adolescents 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,
it
is
intended for use in the most
advanced
phase
of
the
disease
(blast
crisis).
In
children and adolescents, it
can
be
used
in
different
phases
of
the
disease
(chronic,
accelerated
phase
and blast crisis).
•
Philadelphia
chromosome
positive acute lymphoblastic
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.
Accord
Imatinib inhibits the growth
of these cells.
Accord Imatinib is a treatment
for adults for:
•
Myelodysplastic/myeloproli
ferative
diseases
(MDS/MPD).
These
are
a
group of blood diseases in
which some blood cells start
growing
out
of
control.
Accord Imatinib inhibits the
growth of these cells in a
certain
subtype
of
these
diseases.
•
Hypereosinophilic syndrome
(HES)
and/or
chronic
eosinophilic
leukaemia
(CEL).
These
are
blood
diseases
in
which
some
blood
cells
(named
eosinophils)
start
growing
out
of
control.
Accord
Imatinib in

Ciri produk

PACKAGE INSERT
ACCORD IMATINIB 100 & 400 (IMATINIB TABLETS 100 & 400 MG)
NAME AND STRENGTH OF ACTIVE INGREDIENT
ACCORD IMATINIB 100:
Imatinib Mesilate 119.5 mg equivalent to Imatinib….. 100 mg
ACCORD IMATINIB 400:
Imatinib Mesilate 478 mg equivalent to Imatinib….. 400 mg
PRODUCT DESCRIPTION
ACCORD IMATINIB 100:
Brownish orange, round, biconvex, film-coated tablets, debossed with
‘IM’
and “T1” on either side of breakline on one side and plain on
other side.
The breakline is not intended for breaking the tablet.
ACCORD IMATINIB 400:
Brownish orange, oval shaped, biconvex, film-coated tablets, debossed
with “IM” and “T2” on either side of breakline on one side and
plain on the other side.
The breakline is not intended for breaking the tablet.
PHARMACODYNAMIC PROPERTIES
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 protooncogene, 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.
Pharmacodynamic 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.
The compound shows anti-tumour activity as a single agent.
Imatinib is also an inhibitor of the receptor tyrosine kinases for
platelet-derived growth factor
(PDGF), PDGF-R, and inhibits PDGF-mediated cellular events.
Constitutive activation of the
PDGF receptor or the Abl protein tyrosine kinases as