|Qualitative and quantitative composition:||Single hard capsule contains sodium iodide [131I] Natrii iodidi (131I) in the radioactivity range [1-37 MBq].|
Iodine-131 is obtained by neutron irradiation of tellurium in a nuclear reactor or by extraction from uranium fission products. Iodine-131 has a half-life of 8.02 days. It decays to stable xenon-131, by emission of gamma radiations of 365 keV (81.7%), 637 keV (7.2%) and 284 keV (6.1%) and beta radiation of maximal energy of 606 keV. The full list of excipients in SmPC
|Pharmaceutical form:||Capsule hard.|
|Therapeutic indications:||This product is used in the treatment of: thyroid nodular goitre, hyperthyroidism in the Graves-Basedow’s disease, autonomic nodule and the toxic multinodular goitre. It is used for the thyroid residue ablation after surgery of differentiated thyroid tumours and in the treatment of iodine-accumulating metastases.|
|Shelf life:||21 days from the production date|
|Special precautions for storage:||Store below 25°C.|
Store in original shielding lead container.
Storage of radiopharmaceuticals should be in accordance with national regulations on radioactive materials.
|Nature and contents of container:||Gelatin capsules for therapeutic use are provided in the two types of direct packaging:|
– the polyethylene vial closed with a polyethylene stopper containing iodine absorber and placed in a shielding lead container. The package contains a single capsule. Each box is accompanied by a separate polypropylene applicator (type A) for capsule administration and radioactive source certificate.
– the polypropylene vial closed with a polypropylene stopper containing iodine absorber and placed in a shielding lead container. The package contains a single capsule. Each box is accompanied by a separate polypropylene applicator (type B) for capsule administration and radioactive source certificate.
|Radionuclidic purity:||≥ 99.9%|
|Radiochemical purity:||≥ 95%|
|Enclosure||SmPC – Sodium iodide Na131I POLATOM, capsules for therapeutic use|