Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
deferasirox
Novartis Europharm Limited
V03AC03
deferasirox
All other therapeutic products
beta-Thalassemia; Iron Overload
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.
Revision: 52
Authorised
2006-08-28
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 Aqra d-dokument sħiħ
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 Aqra d-dokument sħiħ