Sodium iodide Na131I POLATOM, capsules for diagnostic use
| Radionuclidic purity: |
≥ 99.9% |
| Radiochemical purity: |
≥ 95% |
| Calibration: | 7 days |
| Expiration: | 21 days from the production date. |
| Storage: | Store below 25°C. |
| Pharmaceutical form: |
Hard capsules. |
| Active substance: |
Sodium iodide (Na131I) [1 - 37 MBq] |
| Excipients: | Sodium carbonate Sodium bicarbonate Disodium hydrogen phosphate dihydrate Sodium thiosulphate pentahydrate Hard gelatin capsule (bovine gelatin, dyes: titanium dioxide, quinoline yellow, indigotine, erythrosine, iron oxides) |
| Package: | Sodium iodide Na131I POLATOM, capsules for diagnostic use, are supplied in the following types of immediate packages: First type of container: The Na131I capsules with an activity of 1 - 4 MBq are supplied in the polypropylene vials, sealed with the polyethylene stoppers. Vials are placed in the shielding lead containers. A single vial can contain up to 10 capsules of the same radioactivity. Second type of container: The Na131I capsules, with an activity of 1 - 37 MBq are supplied in the polyethylene vials, sealed with stoppers equipped with charcoal filter, and placed in shielding lead containers. Every vial contains a single capsule. Each box is accompanied by a separate applicator for capsule administration. |
| 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). |
| Załączniki: |  Sodium iodide Na131I POLATOM, capsules for diagnostic use |