| Qualitative and quantitative composition: | One capsule contains sodium iodide (131I) 37 – 7400 MBq 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. |
| Pharmaceutical form: | Hard capsule. Medium orange hard gelatin capsule, approximately 18 mm long, containing white powder. |
| 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 large euthyroid (nontoxic) goitre. – treatment of papillary and follicular thyroid carcinoma, including metastatic disease. Sodium Iodide (131I) therapy is often combined with surgical intervention and with antithyroid medicinal products. |
| Shelf life: | 21 days from the manufacturing 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 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. or: – 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 – Iodopol, 37-7400 MBq, hard capsules |
