Alsuni Capsules 50mg

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

SUNITINIB MALATE

Boleh didapati daripada:

LOTUS HEALTHCARE MALAYSIA SDN. BHD.

INN (Nama Antarabangsa):

SUNITINIB MALATE

Unit dalam pakej:

28 Capsules; 30 Capsules; 30 Capsules

Dikeluarkan oleh:

Lotus Pharmaceutical Co., Ltd. Nantou Plant

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
ALSUNI CAPSULES
Sunitinib (as Malate) (12.5 mg / 25 mg / 50 mg)
1
WHAT IS IN THIS LEAFLET
1.
What ALSUNI is used for
2.
How ALSUNI works
_3._
Before you use ALSUNI
4.
How to use ALSUNI
5.
While you are using it
6.
Side effects
_7._
Storage and Disposal of ALSUNI
8.
Product Description
9.
Manufacturer
&
Product
Registration Holder
10.
Date of revision
11.
Serial Number
WHAT ALSUNI IS USED FOR
ALSUNI is used to treat adults with
the following types of cancer:
•
Gastrointestinal
stromal
tumour
(GIST), a type of cancer of the
stomach and bowel, after disease
progression on or, where imatinib
(another anticancer medicine) no
longer works or you cannot take
imatinib.
•
Advanced renal cell carcinoma, 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 ALSUNI WORKS
ALSUNI 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 ALSUNI_ _
-
_When you must not use it_
Do
not
take
ALSUNI
if
you
are
allergic to sunitinib or any of the
other ingredients of this medicine.
-
_Before you start to use it_
PREGNANCY AND BREAST-FEEDING
If you are pregnant, think you may be
pregnant or are planning to have a
baby,
ask
your
doctor
for
advice
before taking this medicine.
If you might get pregnant, you should
use
a
reliable
method
of
contraception during treatment with
ALSUNI.
If you are breast-feeding, tell your
doctor.
You
should
not
breastfeed
during treatment with ALSUNI.
-
_Taking other medicines_
Tell your doctor or pharmacist if you
are taking, have recently taken, or
might
take
any
other
medicines,
including medicines obtained without
a
prescription
and
even
those
not
prescribed.
Some medicines can affect the levels
of ALSUNI in your body. You should
inform your doctor if you are taking
medi

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REGULATORY APPROVAL
SUNITINIB MALAYSIA 12,5MG 25MG
50MG X28 X30 CAPS PIL
Die Cut size
Created
Modified
Proof round
ART Code
2 Pages - 293x700mm
DE 12/08/2021
DE 20/10/2022
04
ARTDB020843P
ALSUNI CAPSULES
12.5 mg / 25 mg / 50 mg
SUNITINIB MALATE
PACKAGE INSERT
1. NAME OF THE MEDICINAL PRODUCT
ALSUNI CAPSULES 12.5 MG / 25 MG / 50 MG
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
ALSUNI CAPSULES 12.5 MG
Each capsule contains sunitinib malate, equivalent to 12.5 mg of
sunitinib.
ALSUNI CAPSULES 25 MG
Each capsule contains sunitinib malate, equivalent to 25 mg of
sunitinib.
ALSUNI CAPSULES 50 MG
Each capsule contains sunitinib malate, equivalent to 50 mg of
sunitinib.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
ALSUNI CAPSULES 12.5 MG
Hard capsules with dark brown opaque cap and dark brown opaque body,
13.8‑14.8 mm, printed
with white ink “LP” on the cap, “650” on the body, and
containing yellow to orange granular
powder.
ALSUNI CAPSULES 25 MG
Hard capsules with light brown opaque cap and dark brown opaque body,
15.4‑16.4 mm, printed
with white ink “LP” on the cap, “651” on the body, and
containing yellow to orange granular
powder.
ALSUNI CAPSULES 50 MG
Hard capsules with light brown opaque cap and light brown opaque body,
17.5‑18.5 mm, printed
with white ink “LP” on the cap, “653” on the body, and
containing yellow to orange granular
powder.
4. CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
4.1.1