Country: Danimarka
Lingwa: Daniż
Sors: Lægemiddelstyrelsen (Danish Medicines Agency)
Natriumiodid (131-I)
Monrol Europe S.R.L.
V10XA01
Sodium iodide (131-I)
37-7400 MB
kapsler, hårde
2013-03-06
15 JULY 2019 SUMMARY OF PRODUCT CHARACTERISTICS FOR MONIYOT-131 CAPSULE T, HARD CAPSULES 1. NAME OF THE MEDICINAL PRODUCT Moniyot-131 Capsule T 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One hard capsule contains 37-7400 MBq sodium iodide ( 131 I) at time of calibration. 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. Excipient(s) with known effect : One hard capsule contains 129.68 mg sodium. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard capsules Transparent hard gelatine capsules containing a white to light brown powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Radioiodide thyroid therapy is indicated in adults and children for: Hyperthyroidism: 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 medicinal products. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION This medicinal product should be administered only by authorised healthcare professionals in designated clinical settings (see section 6.6). _dk_hum_02244_spc.doc_ _Page 1 of 21_ Posology The activity to be administered is a matter of clinical judgement. The therapeutic effect is only achieved after several weeks. The activity of the capsule should be determined before use. _Adults _ _Treatment of hyperthyroidism_ In case of failure or impossibility to pursue the medical treatment, radioactive iodide may be administered to treat the hyperthyroidism. Patients should be rendered euthyroid medically whenever possible before giving radioiodine treatment for hyperthyroidism. The activity to be administered depends on the diagnosis, Aqra d-dokument sħiħ