Country: Armenia
Language: English
Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
deferasirox
Novartis Pharma Stein AG
V03AC03
deferasirox
250mg
tablets dispersible
(28/4x7/) in blister
Prescription
Registered
2018-02-02
INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT EXJADE 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. COMPOSITION: _ACTIVE SUBSTANCE_: Deferasirox; Exjade 250 mg dispersible tablets: each dispersible tablet contains 250 mg deferasirox; excipient with known effect: each dispersible tablet contains 272 mg lactose. Exjade 500 mg dispersible tablets: each dispersible tablet contains 500 mg deferasirox; excipient with known effect: each dispersible tablet contains 544 mg lactose. _EXCIPIENTS_: lactose monohydrate, crospovidone type A, cellulose, microcrystalline, povidone, sodium laurilsulfate, silica, colloidal anhydrous, magnesium stearate. PHARMACEUTICAL FORM: dispersible tablets. PHARMACOTHERAPEUTIC GROUP. Iron chelating agents. ATC CODE: V03AC03. CLINICAL PARTICULARS._ _ _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) aged 2 to 5 years, - in adult and paediatric patients with beta thalassaemia major with iron overload due to infrequent blood transfusions (<7 ml/kg/month of packed red blood cells) aged 2 years and older, - in adult and paediatric patients with other anaemias aged 2 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 thal Read the complete document
1 ANNEX I BRIEF DESCRIPTION OF THE MEDICINAL PRODUCT 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 MEDICAL PRODUCT Exjade 250 mg dispersible tablets. Exjade 500 mg dispersible tablets. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _active substance:_ deferasirox; Exjade 250 mg dispersible tablets: each dispersible tablet contains 250 mg deferasirox; excipient with known effect: each dispersible tablet contains 272 mg lactose. Exjade 500 mg dispersible tablets: each dispersible tablet contains 500 mg deferasirox; excipient with known effect: each dispersible tablet contains 544 mg lactose; _excipients:_ For a complete list of excipients, see Section 6.1. 3. PHARMACEUTICAL FORM Dispersible tablets. Exjade 250 mg dispersible tablets 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 500 mg dispersible tablets 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 DATA 4.1 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) aged 2 to 5 years, - in adult and paediatric patients with beta thalassaemia major with iron overload due to infrequent blood transfusions Read the complete document