Glivec Tablet 100mg

Nazione: Malesia

Lingua: inglese

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

Principio attivo:

IMATINIB MESYLATE

Commercializzato da:

NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.

INN (Nome Internazionale):

IMATINIB MESYLATE

Confezione:

20Tablet Tablets; 60Tablet Tablets; 120 Tablet Tablets; 60 Tablet Tablets

Prodotto da:

NOVARTIS PHARMA PRODUKTIONS GMBH

Foglio illustrativo

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
GLIVEC
® TABLET
Imatinib Mesylate
(100mg, 400mg)
1
WHAT IS IN THIS LEAFLET
1.
What Glivec is used for
2.
How Glivec works
3.
Before you use Glivec
4.
How to use Glivec
5.
While you are using Glivec
6.
Side effects
7.
Storage and Disposal of Glivec
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
11.
Serial Number
WHAT GLIVEC IS USED FOR
Glivec is a medicine to treat cancer.
Glivec 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.
Glivec 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/myeloproliferativ
e 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 GLIVEC WORKS
Glivec works by slowing the growth of
abnormal cells. Glivec kills the
abnormal cells while leaving normal
cells alone in the diseases listed above.
If you have any questions about how
Glivec works or why this medicine has
been prescribed for you, ask your
doctor.
BEFORE YOU USE GLIVEC
Your Glivec 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 _
�

Scheda tecnica

Novartis
Page 2
Malaysian Package Insert
10-Mar-2022
Glivec film-coated tablets
GLIVEC

Protein-tyrosine kinase inhibitor
DESCRIPTION AND COMPOSITION
PHARMACEUTICAL FORMS
FILM-COATED TABLETS
GLIVEC

100 and 400 mg film-coated tablets
Note: Glivec

is known as Gleevec
®
(imatinib mesilate) tablets in the US, Canada and Israel.
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
•
Glivec 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
10-Mar-2022
Glivec film-coated tablets
•
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