Vativio Tablet 100mg

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

IMATINIB MESYLATE

Boleh didapati daripada:

DKSH MALAYSIA SDN BHD

INN (Nama Antarabangsa):

IMATINIB MESYLATE

Unit dalam pakej:

60tablet Tablets; 120tablet Tablets

Dikeluarkan oleh:

NOVARTIS PHARMA PRODUKTIONS GMBH

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
VATIVIO
®
TABLET
Imatinib Mesylate
(100mg, 400mg)
WHAT IS IN THIS LEAFLET
1.
What Vativio is used for
2.
How Vativio works
3.
Before you use Vativio
4.
How to use Vativio
5.
While you are using Vativio
6.
Side effects
7.
Storage and Disposal of Vativio
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of Revision
WHAT VATIVIO IS USED FOR
Vativio is a medicine to treat cancer.
Vativio is a treatment for adults and
children for:
-
chronic myeloid leukemia (CML)
-
acute
lymphoblastic
leukemia
(ALL)
with
Philadelphia
chromosome
positive
(Ph-
positive ALL).
Leukemia
is
cancer
of
white
blood
cells. These white blood cells usually
help the body to fight infections. CML
and
ALL
are
cancers
of
the
blood
which makes the body produce too
many abnormal white blood cells.
Vativio is also a treatment for adults
for:
•
Certain
types
of
gastrointestinal
stromal tumors (GIST). GIST are
cancers of the stomach and the
bowels.
•
Certain
types
of
dermatofibrosarcoma 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 VATIVIO WORKS
Vativio works by slowing the growth
of
abnormal
cells.
Vativio
kills
the
abnormal cells while leaving normal
cells
alone
in
the
diseases
listed
above.
If you have any questions about how
Vativio works or why this medicine
has been prescribed for you, ask your
doctor.
BEFORE YOU USE VATIVIO
Your
Vativio
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
leaflet.
-
_When you must not use it _
�

Ciri produk

Novartis
Page 2
Malaysian Package Insert
04-Oct-2021
Vativio
VATIVIO

Protein-tyrosine kinase inhibitor
DESCRIPTION AND COMPOSITION
PHARMACEUTICAL FORMS
FILM-COATED TABLETS
100 MG TABLETS, DIVISIBLE
Very dark yellow to brownish orange film-coated tablets, biconvex with
debossed “NVR” on one
side and “SA” and score on the other side.
400 MG TABLETS, DIVISIBLE
Very dark yellow to brownish orange, ovaloid, biconvex with beveled
edges. De-bossed with “400”
on one side and score on the other side and “SL” on each side of
the score.
ACTIVE SUBSTANCE
FILM-COATED TABLETS
Each film-coated tablet contains 100 or 400 mg imatinib (as mesilate
beta crystals).
EXCIPIENTS
100 AND 400 MG (DIVISIBLE OR NON-DIVISIBLE) FILM-COATED TABLETS
Tablet content: Cellulose microcrystalline, Crospovidone,
Hypromellose, Magnesium stearate, Silica
colloidal anhydrous.
Coating content: Hypromellose, Macrogol, Talc, Iron oxide, red (E
172), Iron oxide, yellow (E 172).
Pharmaceutical formulations may vary between countries.
INDICATIONS
•
Vativio is indicated for the treatment of adult and pediatric patients
with newly diagnosed
chronic myeloid leukemia (CML) as well as for the treatment of adult
and pediatric
patients with CML in blast crisis, accelerated phase, or in chronic
phase after failure of
interferon-alpha therapy.
•
adult patients with unresectable and/or metastatic malignant
gastrointestinal stromal
tumours (GIST).
Novartis
Page 3
Malaysian Package Insert
04-Oct-2021
Vativio
•
adjuvant treatment of adult patients following resection of GIST.
Patients who have a low
or very low risk of recurrence should not receive adjuvant treatment.
•
adult and pediatric patients with newly diagnosed Philadelphia
chromosome positive
acute lymphoblastic leukemia (Ph+ ALL) integrated with chemotherapy.
•
adult patients with relapsed or refractory Ph+ ALL as monotherapy.
•
adult patients with myelodysplastic/myeloproliferative diseases
(MDS/MPD) associated
with platelet-derived growth factor receptor (PDGFR) gene
re-arrange