APO-IMATINIB 400MG TABLETS

Country: Малезија

Језик: Енглески

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

Активни састојак:

IMATINIB MESYLATE

Доступно од:

PHARMAFORTE (MALAYSIA) SDN. BHD.

INN (Међународно име):

IMATINIB MESYLATE

Јединице у пакету:

30tablet Tablets

Произведен од:

APOTEX INC

Информативни летак

APO-IMATINIB TABLETS
Imatinib Mesylate (100mg, 400mg)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What Apo-Imatinib is used for
2.
How Apo-Imatinib works
3.
Before you use Apo-Imatinib
4.
How to use Apo-Imatinib
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Apo-
Imatinib
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT APO-IMATINIB
IS USED FOR
Apo-Imatinib 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 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. Apo-Imatinib
inhibits the growth of these cells.
Apo-Imatinib 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. Apo-
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.
Apo-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. Apo-Imatinib
in

Карактеристике производа

APO‐IMATINIB 100MG AND 400MG TABLETS
Imatinib Mesylate Tablets
PRODUCT DESCRIPTION
100 MG: Brownish orange, round biconvex, beveled‐edge film‐
coated tablets. Engraved "IMA" over score "100" on one side,
"APO" on the other side.
400
MG:
Brownish
orange,
capsule
shaped,
biconvex
film‐
coated
tablets.
Engraved
"IMA"
score
"400"
on
one
side,
"APO" on the other side.
PHARMACOLOGY
Pharmacodynamics:
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.
_In vivo_ 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.
_In _
_vitro_,
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 o