Land: Noregur
Tungumál: norska
Heimild: Statens legemiddelverk
Natriumjodid (123I)
GE Healthcare B.V.
V09FX02
Natriumjodid (123I)
Kapsel, hard
Beholder av plast med blyemballasje 1 stk
C
Markedsført
2006-07-14
_ _ SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Sodium Iodide [ 123 I] Capsules, GE Healthcare 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Sodium Iodide(123-I), 3.7, 7.4, 11.1, 18.5 and 37 MBq/capsule at reference date and hour. Iodine-123 is a cyclotron product with a physical half-life of 13.2 h. Iodine-123 decays emitting pure gamma radiation with predominant energies of 159 keV and 27 keV. Excipient(s) with known effect: Sodium 97.4 mg/capsule For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Capsule, hard. Colourless gelatine capsule. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS This medicinal product is for diagnostic use only. Sodium Iodide [123-I] Capsules are used as a diagnostic agent in the functional or morpho- logical 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) lies 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. _ _ Renal/hepatic impairment Sodium Iodide has not been studied in patients with significant renal or hepatic impairment. Careful consideration of the activity to be administered is required since an increased radiation exposure is possible in these patients (see section 4.4). 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. Method of administration. The capsule is administered orally together with a drink. It should be swallowed whole. Imaging is carried out 3-6 Lestu allt skjalið