Страна: Норвегия
Язык: норвежский
Источник: Statens legemiddelverk
Natriumjodid (131I)
GE Healthcare Buchler GmbH & Co. KG
V10XA01
Natriumjodid (131I)
Kapsel, hard
Beholder av plast med blyemballasje 1x50 MBq
C
Markedsført
2006-07-14
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF MEDICINAL PRODUCT THERACAP 131 TM 2. QUALITATIVE AND QUANTITATIVE COMPOSITION THERACAP is presented as a single yellow capsule containing sodium iodide ( 131 I) in the following dosage range; 37 MBq - 5.55 GBq at the activity reference date. Each capsule contains a maximum of 20 µg of sodium iodide ( 131 I). Iodine-131 is produced by fission of uranium-235 or by neutron bombardment of stable tellurium in a nuclear reactor. Iodine-131 has a half-life of 8.02 days. It decays by emission of gamma radiations of 365 keV (81.7 %), 637 keV (7.2 %) and 284 keV (6.1 %) and beta radiations of maximal energy of 606 keV to stable xenon-131. Excipient(s) with known effect: One hard capsule contains: 50 mg sodium. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Capsule hard. Yellow gelatine capsule. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Radioiodine thyroid therapy is indicated in adults and children for: Hyperthyroidism: Treatment of Graves’ disease, toxic multinodular goitre or autonomous nodules. Treatment of papillary and follicular thyroid carcinoma including metastatic disease. Sodium iodide ( 131 I) therapy is often combined with surgical intervention and with antithyroid medicinal products. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION This medicinal product should be administered only by authorized healthcare professionals in designated clinical settings (see section 6.6). Posology 2 The activity to be administered is a matter for clinical judgement. The therapeutic effect is only achieved after several weeks. The activity of the capsule should be determined before use. Adults _Treatment of hyperthyroidism_ In case of failure or impossibility to pursue the medical treatment, radioactive iodide may be administered to treat the hyperthyroidism. Patients should be rendered euthyroid medically whenever possible before giving radioiodine treatment for hyperthyroidism. The activity to be administered depends on the diagnosis Прочитать полный документ