Страна: Норвегія
мова: норвезька
Джерело: Statens legemiddelverk
Natriumjodid (123I)
GE Healthcare B.V.
V09FX02
Natriumjodid (123I)
37 MBq/ ml
Injeksjonsvæske, oppløsning
Hetteglass 370 MBq
C
Markedsført
2017-01-12
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Sodium Iodide [ 123 I] injection, GE Healthcare 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Sodium Iodide [ 123 I], 37 MBq/ml at reference date and hour. At calibration time, the radionuclidic purity is at least 99.9 % and the main radionuclidic impurities (iodine-125 and tellurium-121) occur for less than 0.05 %. Iodine-123 is a cyclotron product with a physical half-life of 13.2 hours. Iodine-123 decays emitting pure gamma radiation with predominant energies of 159 keV and 27 keV. Excipient(s) with known effect: This medicinal product contains:Sodium 3.99 mg/ml. 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 This medicinal product is for diagnostic use only. Sodium Iodide [ 123 I] Injection is used as a diagnostic agent in the functional or morphological study of the thyroid gland by means of: - Scintigraphy - Radioactive iodine uptake test The 24 hours uptake data are generally used in calculating the therapeutic dose. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Adults_ _ The recommended activities for an adult patient (70 kg) is between 3.7 and 14.8 MBq. The lower activity (3.7 MBq) is recommended for uptake studies and the higher doses (11.1 - 14.8 MBq) for thyroid scintigraphy. However for each individual case, the dose is decided by the specialist concerned. Determination of the rate of thyroid iodine-123 uptake should be carried out in accordance with well established standard procedures. GE Healthcare B.V. Summary of Product Characteristics - 2/12 - MT nr 94-193 Sodium Iodide [ 123 I] Injection, GE Healthcare Paediatric population The use in children and adolescents has to be considered carefully, based upon clinical needs and assessing the risk/benefit ratio in this patient group. The activities to be administered to children and to adolescents may be calculated according to the EANM Dosage Card (Versi Прочитайте повний документ