Quốc gia: Na Uy
Ngôn ngữ: Tiếng Na Uy
Nguồn: Statens legemiddelverk
Natriumjodid (131 I)
Cis bio international
V10XA01
Sodium iodide (131 I)
50 MBq
Kapsel, hard
Hetteglass i blyemballasje 3700 MBq
C
Markedsført
2007-08-01
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT CAPSION 50-3,700 MBq capsule, hard. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 50 to 3,700 MBq sodium iodide ( 131 I) at calibration date. Iodine-131 is produced by fission of uranium-235 and by neutron bombardment of stable tellurium in a nuclear reactor. Iodine-131 has a half-life of 8.04 days. It decays by emission of gamma radiation of 365 keV (81.2 %), 637 keV (7.3 %) and 284 keV (6.1 %) and beta radiations of maximal energy of 606 keV to stable xenon-131. Excipient with known effect: Each capsule contains 110 mg of sodium. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Capsule hard. Capsule green and orange. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Radioiodine 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 iodide ( 131 I) therapy is often combined with surgical intervention and with antithyroid medications. 2 4.2. POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY The activity administered is a matter for clinical judgment. The therapeutic effect is only achieved after several weeks. · FOR THE TREATMENT OF HYPERTHYROIDISM Patients should be rendered euthyroid medically whenever possible before giving radioiodine treatment for hyperthyroidism. The dose required depends on the diagnosis, the size of the gland, thyroid uptake and iodine clearance. The range of activities currently prescribed, irrespective of the method used, vary in the range 200–800 MBq, but repeated treatment may be necessary. Re-treatment after six months is indicated for persisting hyperthyroidism. The following target organ doses may be used for posology calculation: autonomous nodule 300 – 400 Gy absorbed dose to target organ toxic multinodular goitre 150 – 200 Gy absorbed dose to target organ Graves’ disease 200 Gy absorbed dose to target or Đọc toàn bộ tài liệu