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%
EnclosureSmPC – Iodopol, 37-7400 MBq, hard capsules