Land: Norge
Språk: norsk
Kilde: Statens legemiddelverk
Natriumjodid (131I)
GE Healthcare Buchler GmbH & Co. KG
V09FX03
Natriumjodid (131I)
3.7 MBq
Kapsel, hard
Beholder av plast med skumpolster i blybeskyttelse 10 stk
C
Markedsført
2004-10-06
_ _ SUMMARY OF PRODUCT CHARACTERISTICS FOR SODIUM IODIDE ( 131 I) DIAGNOSTIC CAPSULES, GE HEALTHCARE 1. NAME OF THE MEDICINAL PRODUCT Sodium Iodide ( 131 I) Diagnostic Capsules, GE Healthcare 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Sodium iodide( 131 I) Diagnostic Capsules are presented as a white capsule. Each capsule contains 3.7 MBq (100 Ci) at the first reference date. At subsequent reference dates, at weekly intervals, the nominal activity per capsule is shown in the table below - Reference date Days after first reference Activity, MBq ( Ci) 1 0 3.7 (100) 2 7 2.02 (55) 3 14 1.10 (30) 4 21 0.603 (16) 5 28 0.329 (9) 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. Excipients with known effect: Sodium: 85.28 mg/capsule. This needs to be taken into consideration by patients on a sodium controlled diet. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Capsules, hard. White, opaque gelatine capsules 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS This medicinal product is for diagnostic use only. 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 dose can be used to calculate the activity required for radioiodine therapy. In the management of thyroid carcinoma, sodium iodide is used to identify thyroid remnants and metastases (after ablation). _ _ Thyroid scanning for benign conditions with iodine-131 can be performed but only when radiopharmaceuticals with more favourable dosimetry, e.g. iodine-123 or technetium-99m are not available. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _ _ _Adults _ The recommended activities for an adult patient (70 kg) are as follows: For thyroid uptak Les hele dokumentet