|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.|
|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 – Iodopol, 37-7400 MBq, hard capsules|