ALVOTINIB 400MG FILM-COATED TABLETS

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

IMATINIB MESYLATE

Boleh didapati daripada:

LOTUS HEALTHCARE MALAYSIA SDN. BHD.

INN (Nama Antarabangsa):

IMATINIB MESYLATE

Unit dalam pakej:

3 x 10's tablet Tablets

Dikeluarkan oleh:

Remedica Ltd.

Risalah maklumat

_Consumer Medication Information Leaflet (RiMUP)_
ALVOTINIB TABLET
Imatinib (100mg, 400mg)
WHAT IS IN THIS LEAFLET
1.
What Alvotinib is used for
2.
How Alvotinib works
3.
Before you use Alvotinib
4.
How to use Alvotinib
5.
While you are using
Alvotinib
6.
Side effects
7.
Storage & disposal of
Alvotinib
8.
Product description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
WHAT ALVOTINIB IS USED FOR
Alvotinib is a medicine containing
an active substance called
imatinib. Alvotinib is used to treat
cancer of the white blood cells,
also known as leukaemia.
Alvotinib is also used to treat
cancer of the stomach and
intestines.
_ _
HOW ALVOTINIB WORKS
This medicine works by inhibiting
the growth of abnormal cells.
BEFORE YOU USE ALVOTINIB
-
_When you must not use it _
_ _
Do not take Alvotinib tablets if you
are:
•
allergic (hypersensitive) to
imatinib or any of the other
ingredients of Alvotinib
tablets
_(see ingredient list) _
•
are pregnant or planning to be
pregnant
•
if you are breast feeding
If you have one of these conditions,
do not take this medicine and
inform your doctor.
_ _
-
_Before you start to use it _
If you:
•
have liver, kidney, heart
problems or have high blood
pressure
•
are taking the medicine
levothyroxine (because your
thyroid has been removed)
If you have one of these
conditions,
INFORM YOUR
DOCTOR
. You doctor will take it
into account during your
treatment with Alvotinib
tablets.
_ _
-
_Taking other medicines _
Please tell your doctor or
pharmacist if you are taking or
have recently taken any other
medicines, including medicines
obtained without a prescription.
HOW TO USE ALVOTINIB
-
_How much to use _
Take Alvotinib exactly as directed
by your doctor. Do not take more
or less than instructed by your
doctor.
Follow your doctor's instructions
carefully. Do not stop this medicine
unless your doctor has advised you
to do so.
_ _
-
_When to use it _
Take Alvotinib with food and
plenty of water. This will help to
reduce any irritation to the
stomach.
If you are unable

Ciri produk

Controlled Medicine
ALVOTINIB 100MG FILM-COATED TABLETS
ALVOTINIB 400MG FILM-COATED TABLETS
IMATINIB
PRODUCT PARTICULARS
1.NAME OF PRODUCT
Alvotinib 100mg film-coated tablets Alvotinib 400mg film-coated
tablets
2.
NAME AND STRENGTH OF ACTIVE LNGREDIENT(S)
Each Alvotinib 100mg film-coated tablets contain 100mg of imatinib (as
mesilate).
Each Alvotinib 400mg film-coated tablets contain 400mg of imatinib (as
mesilate).
3.
DOSAGE FORM
Film-coated tablets
4.
PRODUCT DESCRIPTION
Alvotinib100 mg film-coated tablets:
Dark yellow to brownish-orange, round shaped, film-coated tablets with
a break-line on one side and '1 00' on the other side
Alvotinib 400 mg film-coated tablets:
Dark yellow to brownish-orange, oval shaped, film-coated tablets with
a break-line on one side and '400' on the other side
5.1.
PHARMACODYNAMICS
lmatinib 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 leukaemic cells from
Philadelphia chromosome positive
chronic myeloid leukaemia (CML) and acute lymphoblastic leukaemia
(ALL) patients. lmatinib is also an inhibitor of the
receptor tyrosine kinases for platelet-derived growth factor (PDGF)
and stem cell factor (SCF), c-Kit, and inhibits PDGF- and SCF-mediated
cellular events. 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
gastrointestinal stromal tumor (GIST) cells, which express an
activating KIT mutation. Constitutive activation of the
PDGFR or the ABL protein tyrosine kinases as a consequence of fusion
to diverse partner proteins or constitutive production of PDGF have
been implicated in the
pathogenesis of MDS/MPD, HES/CEL and DFSP. In addition,