IMINOX TABLET 100MG

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

IMATINIB MESYLATE

Boleh didapati daripada:

IDAMAN PHARMA MANUFACTURING SDN. BHD.

INN (Nama Antarabangsa):

IMATINIB MESYLATE

Unit dalam pakej:

60 Tablets

Dikeluarkan oleh:

Shilpa Medicare Limited

Risalah maklumat

_Consumer Medication Information Leaflet (RiMUP) _
IMINOX TABLET
Imatinib (100 mg, 400 mg)
1
WHAT IS IN THIS LEAFLET
1.
What IMINOX is used for
2.
How IMINOX works
3.
Before you use IMINOX
4.
How to use IMINOX
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of IMINOX
8.
Product description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT IMINOX IS USED FOR
IMINOX 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.
IMINOX is also a treatment for adults
for:
•
MYELODYSPLASTIC/MYELOPROLIFERATIVE
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 of these
cells.
•
AGGRESSIVE
SYSTEMIC
MASTOCYTOSIS
(

Ciri produk

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Front Page
872 mm
170 mm
30 mm
Imatinib
100 mg&400 mg - KLD Leaflet
Size : 170 x 872 mm Folding size: 170x30 mm
Font Size: 8pt
NAME OF THE MEDICINE
IMINOX TABLET 100MG
IMINOX TABLET 400MG
COMPOSITION
ACTIVE INGREDIENT:
IMINOX TABLET 100MG
Each film-coated tablet contains imatinib mesilate equivalent to
100mg imatinib.
IMINOX TABLET 400MG
Each film-coated tablet contains imatinib mesilate equivalent to
400mg imatinib.
EXCIPIENTS:
100MG AND 400MG FILM-COATED TABLETS
Povidone K-30 (Plasdone K-29/32), Magnesium Stearate, Opadry
Brown 02F86982.
DESCRIPTION
IMINOX TABLET 100MG
Dark
yellow
to
brownish
orange
colored,
film
coated
tablets,
round, biconvex with beveled edges debossed with ‘S’ and ‘1’
on
either side of break line on one side and plain on other side.
IMINOX TABLET 400MG
Dark
yellow
to
brownish
orange
colored,
film
coated
tablets,
capsule shaped, biconvex with beveled edges debossed with 'S'
and '2' on either side of break line on one side and plain on other
side.
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 ofthese receptor kinases.
PHARMACODYNAMIC EFFECTS
Imatinib
is
a
protein-tyrosine
kinase
inhibitor,
which potently
inhibits
the
breakpoint
cluster
region-Abelson
(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 leukemic
cells
from
Philadelphia
chromosome positi