Nibinase 12.5 (Sunitinib Hard Gelatin Capsules 12.5 mg)

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

SUNITINIB MALATE

Boleh didapati daripada:

RANBAXY (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

SUNITINIB MALATE

Unit dalam pakej:

3 x 10 Capsules

Dikeluarkan oleh:

Sun Pharmaceutical Industries Limited

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
NIBINASE 12.5, 25 AND 50
Sunitinib Malate Hard Gelatin Capsule (12.5mg, 25mg and 50mg)
Page 1
WHAT IS IN THIS LEAFLET
1.
What
NIBINASE
is used for
2.
How
NIBINASE
work
3.
Before you use
NIBINASE
4.
How to use
NIBINASE
5.
While you are using it
6.
Side effects
7.
Storage
and
Disposal
of
NIBINASE
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
11.
Serial Number
WHAT NIBINASE IS USED FOR
NIBINASE
is used to treat adults with
the following types of cancer:
•
Gastrointestinal
stromal
tumour
(GIST),
a
type
of
cancer
of
the
stomach and bowel, where imatinib
(another
anticancer
medicine)
no
longer
works
or
you
cannot
take
imatinib.
•
Metastatic
renal
cell
carcinoma
(MRCC), a type of kidney cancer
that has spread to other parts of the
body.
•
Pancreatic
neuroendocrine
tumours
(pNET) (tumours of the hormone-
producing cells in the pancreas) that
have
progressed
or
cannot
be
removed with surgery.
HOW NIBINASE WORK
NIBINASE
contains
the
active
substance sunitinib, which is a protein
kinase inhibitor. It is used to treat cancer
by preventing the activity of a special
group of proteins which are known to be
involved in the growth and spread of
cancer cells.
BEFORE YOU USE NIBINASE
‑
_When you must not use it _
Do not take NIBINASE if:

You are allergic to sunitinib or to
any
of
the
other
ingredients
of
NIBINASE
(See
the
end
of
this
leaflet
for
a
complete
list
of
ingredients in
NIBINASE
).
Talk to your doctor or pharmacist before
taking NIBINASE if you:
•
have
high
blood
pressure.
NIBINASE can raise blood pressure.
Your doctor may check your blood
pressure
during
treatment
with
NIBINASE, and you may be treated
with medicines to reduce the blood
pressure, if needed.
•
have
or
have
had
blood
disease,
bleeding
problems,
or
bruising.
Treatment
with
NIBINASE
may
lead to a higher risk of bleeding or
lead to changes in the number of
certain cells in the blood which may
lead to anaemia or affect the ability
of your blood to clo

Ciri produk

_For the use of a Registered Medical Practitioner only _
PRESCRIBING INFORMATION NIBINASE 12.5 / NIBINASE 25 / NIBINASE 50 (Sunitinib Hard Gelatin Capsule 12.5 mg /25 mg / 50 mg)
COMPOSITION
NIBINASE 12.5MG
Each hard gelatin capsule contains:
Sunitinib malate equivalent to Sunitinib……. 12.5 mg
NIBINASE 25MG
Each hard gelatin capsule contains:
Sunitinib malate equivalent to Sunitinib……. 25 mg
NIBINASE 50MG
Each hard gelatin capsule contains:
Sunitinib malate equivalent to Sunitinib……. 50 mg
_Excipients:_ Mannitol, Croscarmellose Sodium, Povidone (K 30),
Magnesium Stearate, Purified Water, Iron
oxide black, Iron oxide red, Iron oxide yellow, Titanium dioxide,
Gelatin.
DESCRIPTION
NIBINASE 12.5MG
Hard gelatin capsule Size 4 with opaque reddish brown cap and opaque
reddish brown body, self-lock
capsule, imprinted with 'RM53' on cap and 'RM53' on body in white ink,
containing Yellow to orange colored
powder..
NIBINASE 25MG
Hard gelatin capsule “Size 3” with opaque caramel cap and opaque
reddish brown body, self-lock capsule,
imprinted with 'RM54' on cap and 'RM54' on body in white ink,
containing Yellow to orange colored powder
NIBINASE 50MG
Hard gelatin capsule “Size 1” with opaque caramel cap and opaque
caramel body, self-lock capsule,
imprinted with 'RM56' on cap and 'RM56' on body in white ink,
containing Yellow to orange colored powder..
NIBINASE contains Sunitinib. Sunitinib is an indolinone derivative and
tyrosine kinase inhibitor with potential
antineoplastic activity. It is described chemically as
N-[2-(diethylamino)ethyl]-5-[(Z)-(5-fluoro-2-oxo-1H-indol-
3-ylidene)methyl]-2,4-dimethyl-1H-pyrrole-3-carboxamide. Sunitinib has
molecular formulae C
22
H
27
FN
4
O
2
and molecular weight is 398.5 g/mol. Sunitinib has the following
structural formula:
STRUCTURAL FORMULAE OF SUNITINIB
PHARMACODYNAMIC AND PHARMACOKINETIC PROPERTIES

PHARMACODYNAMICS
Sunitinib inhibits multiple receptor tyrosine kinases (RTKs) that are
implicated in tumor growth, pathologic
angiogenesis, and metastatic progressi