País: Suecia
Idioma: sueco
Fuente: Läkemedelsverket (Medical Products Agency)
deferipron
DOC Generici Srl
V03AC02
deferiprone
500 mg
Filmdragerad tablett
deferipron 500 mg Aktiv substans
Receptbelagt
Förpacknings: Blister, 100 tabletter
Godkänd
2018-02-05
1 SUMMARY OF PRODUCT CHARACTERISTICS 1 . NAME OF THE MEDICINAL PRODUCT Deferiprone DOC 500 mg film-coated tablets. Deferiprone DOC 1000 mg film-coated tablets. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Deferiprone DOC 500 mg film-coated tablets Each tablet contains 500 mg deferiprone. Deferiprone DOC 1000 mg film-coated tablets Each tablet contains 1000 mg deferiprone. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Deferiprone DOC 500 mg film-coated tablets White to off-white film coated tablets, debossed with ‘DL 500’ with a score line on one side and plain on the other and with dimensions of 14.2 mm x 8.2 mm. The tablet can be divided into equal halves. Deferiprone DOC 1000 mg film-coated tablets White to off-white film coated tablets, debossed with ‘DH 1000’ with a score line on one side and plain on the other and with dimensions of 19.2 mm x 9.2 mm. The tablet can be divided into equal halves. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Deferiprone DOC monotherapy is indicated for the treatment of iron overload in patients with thalassaemia major when current chelation therapy is contraindicated or inadequate. Deferiprone DOC in combination with another chelator (see section 4.4) is indicated in patients with thalassaemia major when monotherapy with any iron chelator is ineffective, or when prevention or treatment of life-threatening consequences of iron overload (mainly cardiac overload) justifies rapid or intensive correction (see section 4.2). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Deferiprone therapy should be initiated and maintained by a physician experienced in the treatment of patients with thalassaemia. Posology Deferiprone is usually given as 25 mg/kg body weight, orally, three times a day for a total daily dose of 75 mg/kg body weight. Dose per kilogram body weight should be calculated to the nearest half tablet. See tables below for recommended doses for body weights at 10 kg increments. To obtain a dose of about 75 mg/kg/day, use Leer el documento completo