IMATERO 400 (Imatinib Tablets 400mg)

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

IMATINIB MESYLATE

Boleh didapati daripada:

CAMBER LABORATORIES SDN. BHD.

INN (Nama Antarabangsa):

IMATINIB MESYLATE

Unit dalam pakej:

3 x 10s Tablets

Dikeluarkan oleh:

Hetero Labs Limited

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
IMATERO 100 (IMATINIB TABLET 100MG)
IMATERO 400 (IMATINIB TABLET 400MG)
Imatinib Mesylate (100mg/400mg)
1
WHAT IS IN THIS LEAFLET
1.
What IMATERO is used for
2.
How IMATERO works
3.
Before you use IMATERO
4.
How to use IMATERO
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of IMATERO
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT IMATERO IS USED FOR
IMATERO is a medicine to treat cancer.
IMATERO is a treatment for adults and
children for:
-
chronic myeloid leukaemia (CML).
-
acute lymphoblastic leukaemia (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
IMATERO is also a treatment for adults
for:
•
certain
types
of
gastrointestinal
stromal tumours (GIST). GIST is a
cancer of the stomach and bowels.
•
Certain
types
of
dermato-
fibrosarcoma
protuberans
(DFSP).
They
arise
from
uncontrolled
cell
growth.
•
Certain
types
of
myelodysplastic/myeloproliferative
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
leukemia (CEL), blood diseases
which make the body produce too many
blood cells.
HOW IMATERO WORKS
IMATERO works by slowing the growth
of abnormal cells. IMATERO kills the
abnormal cells while leaving normal cells
alone in the diseases listed above.
If you have any questions about how
IMATERO works or why this medicine
has been prescribed for you, ask your
doctor.
BEFORE YOU USE IMATERO
Your
IMATERO
treatment
will
be
prescribed by a doctor with experience in
the use of anticancer therapies. Follow all
the doctor’s instructions carefully. They
may differ from the general information
contained in this

Ciri produk

IMATERO 100 (IMATINIB TABLETS 100MG)
IMATERO 400 (IMATINIB TABLETS 400MG)


ACTIVE INGREDIENT
IMATERO 100
Each film-coated tablet contains 100mg imatinib.
IMATERO 400
Each film-coated tablet contains 400mg imatinib.
DOSAGE FORM
Oral film coated Tablets
PRODUCT DESCRIPTIONS
IMATERO 100
White to off white coloured, round, bevel edged scored film coated
tablets, debossed with H on one side and 19
on the other side, 1 and 9 separated by a score line.
IMATERO 400
White to off white coloured, capsule shaped, bevel edged scored film
coated tablets, debossed with H on one
side and 20 on the other side, 2 and 0 separated by a score line.
PHARMACODYNAMICS
Pharmacotherapeutic group: protein-tyrosine kinase inhibitor, ATC
code: L01EA01 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 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 vivo
peripheral blood and bone marrow samples, imatinib shows selective
inhibition of BCR-ABL positive colonies from
CML 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