Sodium iodide Na131I POLATOM, capsules for therapeutic use 131
| 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) [37 – 5500 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: | Gelatin capsules for therapeutic use are provided in the two types of direct packaging: – the polyethylene vial closed with a polyethylene stopper containing isolated iodide 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) with polyethylene plug for capsule administration and certificate of radiopharmaceutical activity or – the polypropylene vial closed with a polypropylene stopper containing isolated iodide 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 certificate of radiopharmaceutical activity. |
| Indications: | The preparation is used in the treatment of: thyroid nodular goitre, hyperthyroidism in the Graves-Basedow’s disease, autonomic nodule and the Plummer‘s disease. It is used for the thyroid residue ablation after surgery of differentiated thyroid tumours and in the treatment of metastases of iodine-accumulating differentiated thyroid cancers. |
| Załączniki: |  Sodium iodide Na131I POLATOM, capsules for therapeutic use |
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