Land: Norge
Språk: norsk
Kilde: Statens legemiddelverk
Natriumjodid (131I)
Curium Netherlands B.V.
V09FX03
Natriumjodid (131I)
Kapsel, hard
Beholder av plast med blyemballasje 7400 MBq
C
Markedsført
2005-05-18
2022 1/17 SUMMARY OF PRODUCT CHARACTERISTICS FOR SODIUM IODIDE (I131) CAPSULES T CURIUMPHARMA, 37-7400 MBQ HARD CAPSULE 1. NAME OF THE MEDICINAL PRODUCT Sodium Iodide (I131) Capsules T Curiumpharma 37-7400 MBq hard capsule 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One hard capsule contains 37-7400 MBq sodium iodide ( 131 I) at the time of calibration. Iodine-131 is produced by fission of uranium-235 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. Excipients _ with known effect _ One hard capsule contains 63.5 mg sodium and 23 mg of sucrose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard capsule. Transparent hard gelatine capsule containing a white to light brown powder. 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 authorised healthcare professionals in designated clinical settings (see section 6.6). Posology The activity to be administered is a matter of 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. 2022 2/17 The activity to be administe Les hele dokumentet