EXJADE 500MG 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

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