Exjade
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
20-11-2023
Charakterystyka produktu
(SPC)
20-11-2023
Sprawozdanie z oceny publicznego
(PAR)
13-08-2018
Składnik aktywny:
deferasirox
Dostępny od:
Novartis Europharm Limited
Kod ATC:
V03AC03
INN (International Nazwa):
deferasirox
Grupa terapeutyczna:
All other therapeutic products
Dziedzina terapeutyczna:
beta-Thalassemia; Iron Overload
Wskazania:
Exjade is indicated for the treatment of chronic iron overload due to frequent blood transfusions (≥ 7 ml/kg/month of packed red blood cells) in patients with beta thalassaemia major aged six years and older.Exjade is also indicated for the treatment of chronic iron overload due to blood transfusions when deferoxamine therapy is contraindicated or inadequate in the following patient groups:in patients with beta thalassaemia major with iron overload due to frequent blood transfusions (≥ 7 ml/kg/month of packed red blood cells) aged two to five years;in patients with beta thalassaemia major with iron overload due to infrequent blood transfusions (< 7 ml/kg/month of packed red blood cells) aged two years and older;in patients with other anaemias aged two years and older.Exjade is also indicated for the treatment of chronic iron overload requiring chelation therapy when deferoxamine therapy is contraindicated or inadequate in patients with non-transfusion-dependent thalassaemia syndromes aged 10 years and older.
Podsumowanie produktu:
Revision: 52
Status autoryzacji:
Authorised
Data autoryzacji:
2006-08-28
Ulotka dla pacjenta
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions.
See section 4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
EXJADE 90 mg film-coated tablets
EXJADE 180 mg film-coated tablets
EXJADE 360 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ _
EXJADE 90 mg film-coated tablets
Each film-coated tablet contains 90 mg deferasirox.
EXJADE 180 mg film-coated tablets
Each film-coated tablet contains 180 mg deferasirox.
EXJADE 360 mg film-coated tablets
Each film-coated tablet contains 360 mg deferasirox.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
EXJADE 90 mg film-coated tablets
Light blue, ovaloid, biconvex film-coated tablet with bevelled edges
and imprints (NVR on one face
and 90 on the other). Approximate tablet dimensions 10.7 mm x 4.2 mm.
EXJADE 180 mg film-coated tablets
Medium blue, ovaloid, biconvex film-coated tablet with bevelled edges
and imprints (NVR on one
face and 180 on the other). Approximate tablet dimensions 14 mm x 5.5
mm.
EXJADE 360 mg film-coated tablets
Dark blue, ovaloid, biconvex film-coated tablet with bevelled edges
and imprints (NVR on one face
and 360 on the other). Approximate tablet dimensions 17 mm x 6.7 mm.
3
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
EXJADE is indicated for the treatment of chronic iron overload due to
frequent blood transfusions
(
7 ml/kg/month of packed red blood cells) in patients with beta
thalassaemia major aged 6 years and
older.
EXJADE is also indicated for the treatment of chronic iron overload
due to blood transfusions when
deferoxamine therapy is contraindicated or inadequate in the following
patient groups:
-
in paediatric patients with beta thalassaemia major with iron overload
due to frequent blood
transfusions (
7 ml/kg/month of packed red blood cells) ag
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions.
See section 4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
EXJADE 90 mg film-coated tablets
EXJADE 180 mg film-coated tablets
EXJADE 360 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ _
EXJADE 90 mg film-coated tablets
Each film-coated tablet contains 90 mg deferasirox.
EXJADE 180 mg film-coated tablets
Each film-coated tablet contains 180 mg deferasirox.
EXJADE 360 mg film-coated tablets
Each film-coated tablet contains 360 mg deferasirox.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
EXJADE 90 mg film-coated tablets
Light blue, ovaloid, biconvex film-coated tablet with bevelled edges
and imprints (NVR on one face
and 90 on the other). Approximate tablet dimensions 10.7 mm x 4.2 mm.
EXJADE 180 mg film-coated tablets
Medium blue, ovaloid, biconvex film-coated tablet with bevelled edges
and imprints (NVR on one
face and 180 on the other). Approximate tablet dimensions 14 mm x 5.5
mm.
EXJADE 360 mg film-coated tablets
Dark blue, ovaloid, biconvex film-coated tablet with bevelled edges
and imprints (NVR on one face
and 360 on the other). Approximate tablet dimensions 17 mm x 6.7 mm.
3
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
EXJADE is indicated for the treatment of chronic iron overload due to
frequent blood transfusions
(
7 ml/kg/month of packed red blood cells) in patients with beta
thalassaemia major aged 6 years and
older.
EXJADE is also indicated for the treatment of chronic iron overload
due to blood transfusions when
deferoxamine therapy is contraindicated or inadequate in the following
patient groups:
-
in paediatric patients with beta thalassaemia major with iron overload
due to frequent blood
transfusions (
7 ml/kg/month of packed red blood cells) ag
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