Imarem 400mg film-coated tablets

Ország: Malajzia

Nyelv: angol

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

Aktív összetevők:

IMATINIB MESYLATE

Beszerezhető a:

EUCOGEN SDN BHD

INN (nemzetközi neve):

IMATINIB MESYLATE

db csomag:

30 Tablets

Gyártó:

Remedica Ltd.

Betegtájékoztató

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
_ _
IMAREM FILM COATED TABLETS
_ _
_IMATINIB_ (100MG AND 400MG)
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WHAT IS IN THIS LEAFLET
1. What Imarem is used for
2. How Imarem works
3. Before you use Imarem
4. How to use Imarem
5. While you are using it
6. Side effects
7. Storage and Disposal of Imarem
8. Product Description
9. Manufacturer
10. Product Registration Holder
11. Date of revision
12. Serial Number
WHAT IMAREM IS USED FOR
Imarem is used in the treatment for adult
and children for:

Chronic myeloid leukemia (CML) as
well as for the treatment for CML in
blast crisis, accelerated phase, or in
chronic phase after failure of
interferon-alpha therapy.
[Leukaemia is cancer of white blood
cells. Chronic myeloid leukemia is a
form of leukaemia in which certain
abnormal white cells (myeloid cells)
start growing out of control]

Philadelphia chromosome positive
acute lymphoblastic leukaemia (Ph+
ALL) integrated with chemotherapy.
[Acute lymphoblastic leukaemia is a
form of leukaemia in which certain
abnormal white cells (named
lymphoblasts) start growing out of
control].
Imarem is also used in the treatment
for adult for:

Certain types of gastrointestinal
stromal tumors (GIST). GIST are
cancers of the stomach and the bowels.

Relapsed or refractory Ph+ ALL as
monotherapy.

Myelodysplastic/myeloproliferative
diseases (MDS/MPD). These are a
group of blood disease in which some
blood cells start growing out of
control.

Hypereosinophilic syndrome (HES)
and/or chronic eosinophilic leukaemia
(CEL) with FIP1L1-PDGFRα re-
arrangement. These are blood diseases
in which some blood cells named
eosinophils start growing out of
controls.

Dermatofibrosarcoma protuberans
(DFSP). DFSP is a cancer of the tissue
beneath the skin in which some cells
start growing out of control.

Aggressive systemic mastocytosis
(ASM). ASM is a rare condition where
certain white blood cells (mast cells)
build up in certain tissue and organs in
the body.
HOW IMAREM WORKS
Imare

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PACKAGE INSERT
1. NAME OF THE PRODUCT
Imarem 100 mg film-coated tablets
Imarem 400 mg film-coated tablets
2. NAME AND STRENGTH OF ACTIVE INGREDIENT
Imarem 100mg contains 100 mg imatinib (as mesilate).
Imarem 400mg contains 400 mg imatinib (as mesilate).
3. DOSAGE FORM
Film-coated tablet.
Imarem, 100mg: Dark yellow to brownish-orange, round shaped,
film-coated tablets with
a breakline on one side and ‘100’ on the other side.
Imarem, 400mg: Dark yellow to brownish-orange, ovaloid shaped,
film-coated tablets with
a breakline on one side and ‘400’ on the other side.
4. PHARMACOLOGICAL PROPERTIES
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 patients and acute
lymphoblastic
leukaemia (ALL) patients..
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_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