|Qualitative and quantitative composition:||One mililiter of solution contains sodium iodide [131I] Natrii iodidi (131I) in the following activities range [37 – 740 MBq]|
Iodine-131 is obtained by neutron irradiation of tellurium oxide in a nuclear reactor or by extraction from uranium fission products. Iodine-131 has a half-life of 8.02 days. It decays to stable xenon-131 by emission of gamma radiation of 365 keV (81.7%), 637 keV (7.2%) and 284 keV (6.1%) and beta radiation of maximum energy of 606 keV.
|Pharmaceutical form:||Solution for injection.|
Clear colourless solution.
|Therapeutic indications:||The medicinal product is both for diagnostic and therapeutic use.|
The product is used in the diagnosis 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 the normal thyroid parenchyma) nodules.
Sodium iodide [131I] may be used to study radioiodine location in thyroid tissue. An estimation of the thyroid uptake and the iodine effective half-life can be used to calculate the dose of radioiodine planned for therapy.
Sodium iodide [131I] is also used in the management of patients with differentiated thyroid carcinoma in order to identify the remaining thyroid tissue after surgery and in the diagnostics of metastases.
This product is used in the treatment of benign thyroid diseases: thyroid nodular goitre, hyperthyroidism in the Graves-Basedow’s disease, autonomic nodule and the toxic multinodular goitre. It is also used for treatment of differentiated thyroid cancer: for the thyroid residue ablation after surgery and in the treatment of iodine-accumulating metastases.
|Shelf life:||28 days from the production date.|
|Special precautions for storage:||Store below 25°C.|
Store in original lead shielding container.
Storage of radiopharmaceuticals should be in accordance with national regulations on radioactive materials.
|Nature and contents of container:||The 10 ml glass vial (type I) closed with a rubber stopper and aluminum cap and placed in a shielding lead container.|
|Radionuclidic purity:||≥ 99.9%|
|Radiochemical purity:||≥ 97%|
|Enclosure||SmPC – Sodium iodide Na131I, solution for injection|