Imatib 400 mg Film Coated Tablets

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

IMATINIB MESYLATE

Boleh didapati daripada:

CIPLA MALAYSIA SDN BHD

INN (Nama Antarabangsa):

IMATINIB MESYLATE

Unit dalam pakej:

30 Tablets

Dikeluarkan oleh:

CIPLA LTD

Risalah maklumat

IMATIB FILM COATED TABLETS _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
IMATINIB MESILATE (100 MG, 400 MG)
_______________________________________________________________________________
Page | 1
WHAT IS IN THIS LEAFLET
1.
What Imatib is used for
2.
How Imatib works
3.
Before you use Imatib
4.
How to use Imatib
5.
While you are using Imatib
6.
Side effects
7.
Storage and Disposal of Imatib
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of Revision
11. Serial Number
WHAT IMATIB IS USED FOR
Imatib is a medicine to treat cancer.
Imatib is a treatment for adults and
children for
:
•
Chronic
myeloid
leukaemia
(CML)
•
Acute
lymphoblastic
leukemia
(ALL)
with
Philadelphia
chromosome
positive
(Ph-
positive ALL).
_ _
Leukaemia is a cancer of white blood
cells. These white cells usually help
the body to fight infection. CML and
ALL are cancers of the blood which
makes the body produce too many
abnormal white blood cells.
Imatib is also a treatment for adults
for:
•
Certain types of gastrointestinal
stromal tumors (GIST). GIST are
cancers of the stomach and the
bowels.
_ _
•
Certain
types
of
dermatofibrosarcoma protuberans
(DFSP).
_ _
They
arise
from
uncontrolled
cell
growth.
_ _
•
Certain
types
of
myelodysplastic/myeloproliferati
ve diseases (MDS/MPD)
,
a group
of blood diseases which make the
body produce too many abnormal
blood cells.
•
Certain
types
of
aggressive
systemic mastocytosis (ASM).
•
Hypereosinophilic
syndrome
(HES)
and/or
chronic
eosinophilic
leukaemia
(CEL),
blood diseases which make the
body
produce
too
many
blood
cells.
HOW IMATIB WORKS
Imatib works by slowing the growth
of
abnormal cells.
Imatib
kills the
abnormal cells while leaving normal
cells
alone
in
the
diseases
listed
above.
If
you
have
any
questions
about how Imatib works or why this
medicine has been prescribed for you,
ask your doctor.
BEFORE YOU USE IMATIB
Your Imatib treatment will be
prescribed by a doctor with
experience in the use of anticancer
therapies. Follow all the doctor’s
instructi

Ciri produk

1
_For the use of a Registered Medical Practitioner or a Hospital or a
Laboratory only OR for Specialist _
_Use only _
IMATIB 100 MG FILM COATED TABLETS
IMATIB 400 MG FILM COATED TABLETS
Imatinib mesilate 100 / 400 mg
COMPOSITION
Imatinib mesilate 100 mg
Each film coated tablet contains imatinib mesilate equivalent to
imatinib 100 mg
Imatinib mesilate 400 mg
Each film coated tablet contains imatinib mesilate equivalent to
imatinib 400 mg
DOSAGE FORM
Film Coated Tablet
PRODUCT DESCRIPTION
Imatinib mesilate 100 mg, divisible
Very dark yellow to brownish orange, film coated tablets, round,
biconvex with bevelled edges,
debossed with "C211"on one side with score on other side.
Imatinib mesilate 400 mg, divisible
Very dark yellow to brownish orange, film coated tablets, Ovaloid,
biconvex with bevelled edges,
debossed with "C212" on one side with score on other side.
The tablet can be divided into equal doses.
PHARMACOLOGY
_ _
_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.
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.
_ _
2
Imatinib is also an inhibitor of the receptor tyros