EXJADE 125MG DISPERSIBLE TABLETS

Country: মাল্যাশিয়া

ভাষা: ইংরেজি

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

সক্রিয় উপাদান:

DEFERASIROX

থেকে পাওয়া:

NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.

INN (International Name):

DEFERASIROX

প্যাকেজ ইউনিট:

28Tablet Tablets; 84Tablet Tablets

Manufactured by:

NOVARTIS PHARMA STEIN AG

তথ্য লিফলেট

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
EXJADE
® DISPERSIBLE TABLETS
Deferasirox
(
125 mg, 500 mg)
1
WHAT IS IN THIS LEAFLET
1.
What Exjade is used for
2.
How Exjade works
3.
Before you use Exjade
4.
How to use Exjade
5.
While you are using Exjade
6.
Side effects
7.
Storage
and
Disposal
of
Exjade
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of Revision
WHAT EXJADE IS USED FOR
Exjade
is
indicated
for
the
treatment of chronic iron overload
due to blood transfusions in adult
and
pediatric
patients
(aged
2
years and over).
It
is
also
indicated
for
the
treatment of chronic iron overload
in patients with non-transfusion-
dependant thalassemia syndromes
aged 10 years and over.
HOW EXJADE WORKS
Exjade traps and removes excess
iron which is then excreted mainly
in the stools.
If you have any questions about
how Exjade works or why this
medicine has been prescribed for
you, ask your doctor, pharmacist
or healthcare provider.
_Monitoring your Exjade treatment _
You will have regular tests (blood,
urine,
or
Magnetic
Resonance
Imaging (MRI)) before and during
treatment.
•
These
will
monitor
the
amount of iron in your body
(level of ferritin, liver and/or
cardiac iron content) to see
how well Exjade is working.
•
The
tests
are
also
done
to
monitor your kidney function
(blood
level
of
creatinine,
presence
of
protein
in
the
urine)
and
liver
function
(blood level of transaminases,
bilirubin
and
alkaline
phosphatase).
•
Your doctor will take these
tests into consideration when
deciding
on
the
dose
of
Exjade
that
is
the
most
suitable for you and will also
use these tests to decide when
you
should
stop
taking
Exjade.
Your eyesight and hearing will be
tested before starting Exjade and
each year during treatment as a
precautionary measure.
If you have any questions about
how Exjade works or why this
medicine has been prescribed for
you, ask your doctor, pharmacist
or healthcare provider.
BEFORE YOU USE EXJADE
Follow all the doctor’s instructions
carefully. They may differ from
the

পণ্য বৈশিষ্ট্য

Novartis
Page 2
Malaysian Package Leaflet
24-Jul-2019
Exjade
EXJADE

Iron chelating agent.
DESCRIPTION AND COMPOSITION
PHARMACEUTICAL FORM(S)
Dispersible tablets.
ACTIVE SUBSTANCE(S)
Each dispersible tablet contains 125 mg / 500 mg deferasirox as active
substance.
Certain dosage strengths may not be available in all countries.
EXCIPIENTS
Lactose monohydrate; crospovidone; microcrystalline cellulose;
povidone (K30); sodium
lauryl sulphate; silicon dioxide; magnesium stearate
DESCRIPTION
Exjade 125mg: Off white, round, flat, beveled edge and imprint
(debossment) “J 125” on one
side and “NVR” on the other.
Exjade 500mg: White to slightly yellow, round, flat tablet with
bevelled edge and imprint
(debossment) “J 500” on one side, “NVR” on the other.
INDICATIONS
Exjade is indicated for the treatment of chronic iron overload due to
blood transfusions
(transfusional hemosiderosis) in adult and pediatric patients (aged 2
years and over).
Exjade is also indicated for the treatment of chronic iron overload in
patients with non-
transfusion-dependent thalassemia syndromes aged 10 years and over.
DOSAGE REGIMEN AND ADMINISTRATION
TRANSFUSIONAL IRON OVERLOAD
DOSAGE REGIMEN
It is recommended that therapy with Exjade be started after the
transfusion of approximately 20
units (about 100 mL/kg) of packed red blood cells or when there is
evidence from clinical
monitoring that chronic iron overload is present (e.g. serum ferritin
>1,000 microgram/L).
Doses (in mg/kg) must be calculated and rounded to the nearest whole
tablet size.
The goals of iron chelation therapy are to remove the amount of iron
administered in
transfusions and, as required, to reduce the existing iron burden. The
decision to remove
Novartis
Page 3
Malaysian Package Leaflet
24-Jul-2019
Exjade
accumulated iron should be individualized based on anticipated
clinical benefit and risks of
chelation therapy.
For patients who are currently on chelation therapy with Exjade
film-coated tablets and
switching to Exjade dispersible tablets, the dose of Exj