IMAMED 400 (Imatinib Mesylate Tablets 400 mg)

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

IMATINIB MESYLATE

Boleh didapati daripada:

UNIMED SDN BHD

INN (Nama Antarabangsa):

IMATINIB MESYLATE

Unit dalam pakej:

30 Tablets

Dikeluarkan oleh:

Shilpa Medicare Limited

Risalah maklumat

IMAMED 100 & 400
Imatinib Mesylate Tablets 100mg / Imatinib Mesylate Tablets 400mg
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What IMAMED is used for
2.
How IMAMED works
3.
Before you use IMAMED
4.
How to use IMAMED
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of IMAMED
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
11.
Serial Number
WHAT IMAMED IS USED FOR
IMAMED 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

PHILADELPHIA CHROMOSOME POSITIVE
ACUTE
LYMPHOBLASTIC
LEUKAEMIA
(PH-POSITIVE ALL). Leukaemia is a
cancer of white blood cells. These
white blood cells usually help the
body
to
fight
infection.
Acute
lymphoblastic
leukaemia
in
which
certain abnormal white blood cells
(named lymphoblasts) start growing
out of control. Imatinib inhibits the
growth of these cells.
IMAMED is also a treatment for adults
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 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 eosinophills) start growing
out of control. Imatinib 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 of the
supporting tissues of these organs.

DERMATOFIBROSARCOMA
PROTUBERANS (DFSP). DFSP is a
cancer of the tissue beneath the skin
in which some cells start growing
out of control. Imatinib inhibits the
growth o

Ciri produk

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Size: 170 x 600 mm
Folding Size: 170 x28 mm
Font Name: Times New Roman
Font Size: 7 pt
R05 : 07.12.2022
Market: ROW (Malaysia)
Designed by: Krishna Nooli
IMATINIB TABLETS 100 MG AND IMATINIB TABLETS 400 MG
PRODUCT NAME
Imamed 100
Imatinib Mesylate Tablets 100 mg
Imamed 400
Imatinib Mesylate Tablets 400 mg
NAME AND STRENGTH OF ACTIVE SUBSTANCE(S)
Imatinib Mesylate 100 mg
Each film coated tablet contains Imatinib Mesylate equivalent to
Imatinib ...100 mg
Imatinib Mesylate 400 mg
Each film coated tablet contains Imatinib Mesylate equivalent to
Imatinib ...400 mg
PRODUCT DESCRIPTION
Imatinib Mesylate Tablets 100 mg:
Dark yellow to brownish orange colored, film coated tablets, round,
biconvex
with bevelled edges debossed with ‘S’ and ‘1’ on either side
of break line on
one side and plain on other side.
Imatinib Mesylate Tablets 400 mg:
Dark yellow to brownish orange colored, film coated tablets, capsule
shaped,
biconvex with bevelled edges debossed with ‘S’ and ‘2’ on
either side of break
line on one side and plain on other side.
PHARMACODYNAMICS
Imatinib is a protein-tyrosine kinase inhibitor, which potently
inhibits the
breakpoint cluster region-Abelson (BCR-ABL) tyrosine kinase at the in
vitro,
cellular, in vivo levels. The compound selectively inhibits
proliferation and
induces apoptosis in BCR-ABL positive cell lines as well as fresh
leukemic
cells from Philadelphia chromosome positive CML and acute
lymphoblastic
leukemia
(ALL)
patients.
In
colony
transformation
assays
using
ex
vivoperipheral blood and bone marrow samples, imatinib shows selective
inhibition of BCR-ABL positive colonies from CML patients.
In vivo the compound shows anti-tumor activity as a single agent in
animal
models using BCR-ABL positive tumor cells.
Imatinib is also an inhibitor of the receptor tyrosine kinases for
platelet-derived
growth factor (PDGF) and stem cell factor (SCF), KIT, and inhibits
PDGF-
and SCF-mediated cellular events. In vitro, imatinib inhibits
proliferation and
induces apoptosis in