Country: Norway
Bahasa: Norway
Sumber: Statens legemiddelverk
Natriumjodid (131I)
GE Healthcare Buchler GmbH & Co. KG
V09FX03
Natriumjodid (131I)
925 MBq/ ml
Injeksjonsvæske, oppløsning
Hetteglass 925 MBq
C
Markedsført
2004-10-06
_ _ _ _ SUMMARY OF PRODUCT CHARACTERISTICS FOR SODIUM ( 131 I) IODIDE, INJECTION, GE HEALTHCARE 1. NAME OF MEDICINAL PRODUCT Sodium ( 131 I) Iodide Injection, GE Healthcare 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Sodium ( 131 I) Iodide: 37-740 MBq/vial (74 MBq/ml) at the activity reference date 0.925-9.25 GBq/vial (925 MBq/ml) at the activity reference date Iodine-131 is produced by fission of Uranium-235 or by neutron bombardment of stable tellurium in a nuclear reactor. It decays by emission of gamma radiations of 365 keV (81.7 %), 637 keV (7.2 %) and 284 (6.1 %) and beta radiations of maximal energy of 0.606 MeV to stable Xenon-131. Iodine-131 has a half-life of 8.02 days. Excipients with known effect: This medicinal product contains 5.9 mg/ml sodium. To be taken into consideration by patients on a controlled sodium diet. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. Clear, colourless solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Diagnostic indications Sodium iodide may be given as a “tracer” dose to study radioiodine kinetics. An estimation of the thyroid uptake and effective half-life obtained with a tracer amount can be used to calculate the activity required for radioiodine therapy. In the management of thyroid carcinoma, sodium iodide is used to identify thyroid remnant and metastases (after ablation). Thyroid scanning for benign conditions with sodium ( 131 I) iodide can be performed but only where circumstances do not allow for radiopharmaceuticals with more favourable dosimetry to be used. Therapeutic indications Radioiodide thyroid therapy is indicated for: Treatment of Graves’ disease, toxic multinodular goitre or autonomous nodules Treatment of papillary and follicular thyroid carcinoma including metastatic disease. _ _ _ _ _ _ Sodium ( 131 I) iodide therapy is often combined with surgical intervention and with antithyroid medications. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Diagnostic use Adults The reco Baca dokumen lengkap