IMATINIB GRINDEKS 100MG HARD CAPSULES

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

IMATINIB MESYLATE

Boleh didapati daripada:

ABG PHARMA SDN BHD

INN (Nama Antarabangsa):

IMATINIB MESYLATE

Unit dalam pakej:

60 Capsules

Dikeluarkan oleh:

JOINT-STOCK COMPANY GRINDEKS

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
IMATINIB GRINDEKS 100MG HARD CAPSULE
_IMATINIB (AS MESYLATE) _100MG
Page 1
WHAT IS IN THIS LEAFLET
1.
What Imatinib Grindeks is used
for
2.
How Imatinib Grindeks works
3.
Before you use Imatinib Grindeks
4.
How to use Imatinib Grindeks
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Imatinib
Grindeks
8.
Product Description
9.
Manufacturer
10.
Product Registration Holder
11.
Date of revision
12.
Serial Number
WHAT IMATINIB GRINDEKS IS USED FOR
Imatinib Grindeks is a medicine
containing an active substance
called imatinib.
Imatinib Grindeks is used in the
treatment for adult 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.
•
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. Imatinib Grindeks
inhibits the growth of these cells
Imatinib Grindeks is also used in
the treatment for adult for:
•
Myelodysplastic/myeloproliferativ
e
diseases (MDS/MPD). These are
a group of blood diseases in which
some blood cells start growing out
of control. Imatinib Grindeks
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. Imatinib Grindeks 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 growth

Ciri produk

PACK INSERT
1.
PRODUCT NAME
Imatinib Grindeks 100 mg hard capsules
2.
NAME AND STRENGTH OF ACTIVE INGREDIENT
Each hard capsule contains imatinib mesilate corresponding to 100 mg
of imatinib.
3.
PRODUCT DESCRIPTION
Brownish-orange hard gelatine capsules. The content – white to light
yellow or brownish yellow
powder.
4.
PHARMACODYNAMICS 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 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.
_Pharmacodynamic effects _
Imatinib is a protein-tyrosine kinase inhibitor which potently
inhibits the Bcr-Abl tyrosine kinase at the,
cellular 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 in animal
models using Bcr- Abl positive
tumour cells.
Imatinib is also an inhibitor of the receptor tyrosine kinases for
platelet-derived growth factor (PDGF),
PDGF- R, and stem cell factor (SCF), c-Kit, and inhibits PDGF- and
SCF-mediated cellular events.
Imatinib inhibits proliferation and induces apoptosis in
gastrointestinal stromal tumour (GIST) cells,
which express an activating kit mutation. Constitutive activation of
the PDGF receptor or the Abl
protein tyrosine kinases as a consequence of fusion to diverse partner
proteins or constitutive production
of PDGF have been implicated in the pathogenesis of MDS/MPD, HES/CEL
and DFSP. Imatinib
inhibits signalling and proliferation of cells dr