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.
Pharmaceutical form: Solution for injection.
Clear, colourless solution.
Therapeutic indications:This medicinal product is for diagnostic use only.

This product is used for diagnosis of thyroid function disorders (hyperthyroidism and hypothyroidism), evaluation of thyroid tissue location (including ectopy), its size, shape, functional analysis of focal lesions: “cold” (not trapping iodine), “warm” (trapping iodine at a similar extent to normal thyroid parenchyma), “hot” (trapping iodine at a higher extent than normal thyroid parenchyma) nodules.

Sodium iodide Na131I POLATOM, capsules for diagnostic use may be used to study radioiodine location in thyroid tissue. An estimation of the thyroid uptake and its effective half-life can be used to calculate the dose absorbed from the activity of radioiodine planned for therapy.

Sodium iodide Na131I POLATOM, capsules for diagnostic use is also used in the management of patients with differentiated thyroid carcinoma to identify the remaining thyroid tissue and in the metastases diagnostics.
Shelf life:21 days from the production date.
Calibration: 7 days.
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 diagnostic use are provided in the two types of direct packaging:
– First type of packaging:
the polypropylene vial closed with a polyethylene stopper, placed in a shielding lead container. Single vial may contain up to 10 capsules of the same radioactivity. Each box is accompanied by a radioactive source certificate.

– Second type of packaging:
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 for capsule administration and radioactive source certificate.
Radionuclidic purity:≥ 99.9%
Indications: Diagnostics of thyroid function disorders (hyperthyroidism and hypothyroidism), evaluation of thyroid tissue location (including ectopy), its size, shape, functional analysis of focal lesions: „cold” (not trapping iodine), „warm” (trapping iodine at a similar extent to normal thyroid parenchyma), „hot” (trapping iodine at a higher extent than normal thyroid parenchyma) nodules.
It is the basic radioisotope in the diagnosis of metastatic lesions of differentiated thyroid cancers (following the surgical removal of the thyroid or radioisotope ablation).
EnclosureSmPC – Sodium iodide Na131I POLATOM, capsules for diagnostic use