Country: Armenia
Language: English
Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
deferasirox
Sandoz S.R.L.
V03AC03
deferasirox
360mg
tablets film-coated
(30/3x10/) in blister
Prescription
Registered
2023-04-21
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. INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT JADENU COMPOSITION: _ACTIVE SUBSTANCE_: Deferasirox; Jadenu 180 mg film-coated tablets: each film-coated tablet contains 180 mg deferasirox; Jadenu 360 mg film-coated tablets: each film-coated tablet contains 360 mg deferasirox. _EXCIPIENTS_: cellulose, microcrystalline; crospovidone; povidone; magnesium stearate; silica, colloidal anhydrous; poloxamer. COATING: opadry blue (hypromellose; titanium dioxide (E171), macrogol 4000; talc; indigo carmine aluminium lake (E132)). PHARMACEUTICAL FORM: film-coated tablets. PHARMACOTHERAPEUTIC GROUP. Iron chelating agents. ATC CODE: V03AC03. CLINICAL PARTICULARS._ _ _INDICATIONS_ _. _ Jadenu 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. Jadenu 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. Jadenu 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. CONTRAINDICATIONS. Hypersensitivity to the active substance or to any of the excipi 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. 1. NAME OF MEDICAL PRODUCT Jadenu 180 mg film-coated tablets. Jadenu 360 mg film-coated tablets. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _active substance:_ deferasirox; Jadenu 180 mg film-coated tablets: each film-coated tablet contains 180 mg deferasirox; Jadenu 360 mg film-coated tablets: each film-coated tablet contains 360 mg deferasirox; _excipients:_ For a complete list of excipients, see Section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablets. Jadenu 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. Jadenu 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. 4. CLINICAL DATA 4.1 INDICATIONS. Jadenu 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. Jadenu 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. Jadenu is also indicated for the treatment of chronic iron Read the complete document