Country: Norway
Bahasa: Norway
Sumber: Statens legemiddelverk
Natriumjodid (123I)
Curium Netherlands B.V.
V09FX02
Natriumjodid (123I)
37 MBq/ ml
Injeksjonsvæske, oppløsning
Hetteglass i blyemballasje 10 ml
C
Markedsført
2005-05-18
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Sodium Iodide (I-123) Injection Curiumpharma (Curiumpharma catalogue number: DRN 5375) 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 2.1 ACTIVE INGREDIENT Sodium Iodide (I-123), 37 MBq/ml at activity reference date and hour. 2.2 PHYSICAL CHARACTERISTICS Iodine-123 is a cyclotron product with a physical half-life of 13.21 h. Iodine-123 decays emitting pure gamma radiation with predominant energies of 159 keV and 27 keV. 123 I is obtained by proton irradiation of enriched Xenon. The radionuclidic purity of the product at expiry date and time is: 123 I > 99.9%. The only detectable radionuclidic impurities are 121 Te 900 Bq/MBq and 125 I 1500 Bq/MBq at expiry date and time. 3 PHARMACEUTICAL FORM Solution for injections. ATC code: V10X A01 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Sodium iodide (I-123) 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 The recommended activities for an adult patient (70 kg) lies between 3.7 to 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 prescribed must be determined by the attending specialist. Determination of the rate of thyroid iodine-123 uptake should be carried out in accordance with well established standard procedures. The activity dosages for children may be calculated from the recommended range of adult dosages, adjusted according to the following equation: Paediatric dosage (MBq)= Adult dosage (MBq) x Child weight (kg) 70 In very young children the maximal adult dosage of 14.8 MBq should be used in the equation in order to obtain images of sufficient quality. 123 I must be given as an intravenous injection: as a routine check, the acti Baca dokumen lengkap