EXJADE 250 MG

देश: इसराइल

भाषा: अंग्रेज़ी

स्रोत: Ministry of Health

सक्रिय संघटक:

DEFERASIROX

थमां उपलब्ध:

NOVARTIS ISRAEL LTD

ए.टी.सी कोड:

V03AC03

फार्मास्यूटिकल फॉर्म:

TABLETS DISPERSIBLE

रचना:

DEFERASIROX 250 MG

प्रशासन का मार्ग:

PER OS

प्रिस्क्रिप्शन प्रकार:

Required

द्वारा बनाया गया:

SANDOZ S.R.L., ROMANIA

चिकित्सीय समूह:

DEFERASIROX

चिकित्सीय क्षेत्र:

DEFERASIROX

चिकित्सीय संकेत:

Exjade is indicated for the treatment of chronic iron overload due to blood transfusions (transfusionalhaemosiderosis) 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 older.Chelation therapy should only be initiated when there is evidence of iron overload (liver iron concentration [LIC] ≥5 mg Fe/g dry weight [dw] or serum ferritin consistently >800 μg/l).LIC is the preferred method of iron overload determination and should be used wherever available

प्राधिकरण की तारीख:

2021-01-31

सूचना पत्रक

PATIENT PACKAGE INSERT IN ACCORDANCE
WITH THE PHARMACISTS’ REGULATIONS
(PREPARATIONS) – 1986
The medicine is dispensed with a doctor’s prescription only
EXJADE
® 125 MG
DISPERSIBLE TABLETS
Each dispersible tablet contains:
deferasirox 125 mg
EXJADE
® 250 MG
DISPERSIBLE TABLETS
Each dispersible tablet contains:
deferasirox 250 mg
EXJADE
® 500 MG
DISPERSIBLE TABLETS
Each dispersible tablet contains:
deferasirox 500 mg
INACTIVE AND ALLERGENIC INGREDIENTS: See section 2
“Important information about some of the ingredients of
the medicine” and section 6 “Further information”.
READ THE LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING
THE MEDICINE. This leaflet contains concise information
about the medicine. If you have further questions, refer to
the doctor or pharmacist.
This medicine has been prescribed for the treatment of your
ailment or for the treatment of your child’s ailment. Do not
pass it on to others. It may harm them even if it seems to
you that their ailment is similar.
1. WHAT IS THE MEDICINE INTENDED FOR?
∙ To treat chronic iron overload caused by blood transfusions,
in adults and children (aged 2 years and above).
∙ To treat chronic iron overload in patients with non-
transfusion-dependent thalassemia from the age of 10
and above.
THERAPEUTIC GROUP: iron chelating agent.
Repeated blood transfusions are sometimes necessary
in patients suffering from certain types of anemia such
as thalassemia, sickle-cell disease and myelodysplastic
syndromes (MDS). However, repeated blood transfusions
can cause a build-up of excess iron. This is because blood
contains iron and the body does not have a natural way to
remove the excess iron received with the blood transfusions.
In patients with non-transfusion-dependent thalassemia,
iron overload may develop over time, mainly due to
increased absorption of dietary iron in response to low blood
cell counts. Over time, the excess iron can damage vital
organs such as the liver and heart.
Iron chelator medicines are used to remove the excess iron
and red

उत्पाद विशेषताएं

EXJ API AUG21 V13 EU SmPC Aug 2021
1.
NAME OF THE MEDICINAL PRODUCT
EXJADE
®
125 mg, 250 mg, 500 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ _
Exjade 125mg: Each dispersible tablet contains 125 mg deferasirox.
Exjade 250mg: Each dispersible tablet contains 250 mg deferasirox.
Exjade 500mg: Each dispersible tablet contains 500 mg deferasirox.
Excipient with known effect:
Exjade 125mg: Each dispersible tablet contains about 136 mg lactose
monohydrate.
Exjade 250mg: Each dispersible tablet contains about 272 mg lactose
monohydrate .
Exjade 500mg: Each dispersible tablet contains about 544 mg lactose
monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Dispersible tablet
Exjade 125mg: White to slightly yellow, round, flat tablets with
bevelled edges and imprints (NVR on
one face and J 125 on the other). Approximate tablet dimensions 12 mm
x 3.6 mm.
Exjade 250mg: White to slightly yellow, round, flat tablets with
bevelled edges and imprints (NVR on
one face and J 250 on the other). Approximate tablet dimensions 15 mm
x 4.7 mm.
Exjade 500mg: White to slightly yellow, round, flat tablets with
bevelled edges and imprints (NVR on
one face and J 500 on the other). Approximate tablet dimensions 20 mm
x 5.6 mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
EXJADE is indicated for the treatment of chronic iron overload due to
blood transfusions
(transfusional haemosiderosis) in adult and paediatric patients (aged
2 years and over).
EXJADE is also indicated for the treatment of chronic iron overload in
patients with non-transfusion-
dependent thalassaemia syndromes aged 10 years and older.
Chelation therapy should only be initiated when there is evidence of
iron overload (liver iron
concentration [LIC] ≥5 mg Fe/g dry weight [dw] or serum ferritin
consistently >800 μg/l). LIC is the
preferred method of iron overload determination and should be used
wherever available.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with EXJADE should be initiated and maintained by physicians
e