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.

Qualitative and quantitative compositions:

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.

List of excipients:

Sodium carbonate

Sodium hydrogen carbonate

Sodium thiosulphate pentahydrate

Sodium chloride

Water for injections

Posology and method of administration:

Sodium iodide Na¹³¹I, solution for injection is a medicinal product for intravenous administration. The product is intended for the direct administration to patients at various doses of radioactivity, depending on the indication. The recommended dose is a matter for clinical judgement. The dose should be established individually for each patient by a nuclear medicine specialist.

The recommended diagnostic activities:

• • • for the scyntygraphic thyroid diagnosis in benigng disease and for the kinetic
      studies of thyroid uptake: 0.15–4 MBq of sodium iodide [¹³¹I] 24 hours prior the examination. Depending on the indication, the thyroid uptake study is conducted also 4–6 hours after sodium iodide [¹³¹I] administration and then again in the first few days.
    • for diagnostics in patients treated for differentiated thyroid carcinoma (for metastases and for thyroid remnant identification): 37–240 MBq (usually 37–74 MBq) of sodium iodide [¹³¹I]. The whole body scintigraphy is usually conducted 72 hours (or more) after sodium iodide [¹³¹I] administration.

In light of the European Directive 97/43/Euratom and current practice throughout Europe, the above activities should be considered only as a general indication. It should be noted that in each country nuclear medicine physicians should respect the diagnostic reference levels (DRL) and the rules laid down by the local legislation. The administration of activities greater than local DRLs should be justified.

The recommended therapeutic activities:

Adults:

Treatment of hyperthyroidism and nodular goitre:

The activity administered is usually in the range of 200–800 MBq but repeated treatment may be necessary.

The required therapeutic dose depends on the diagnosis, the size of lesion or the gland, thyroid uptake and the effective half-life of iodine [¹³¹I] in the lesion or in the thyroid. Patients should be rendered euthyroid medically whenever possible before giving radioiodine treatment for hyperthyroidism.

For thyroid ablation and treatment of metastases:

The administered activity doses of sodium iodide [¹³¹I] following total or sub total thyroidectomy to ablate remaining thyroid tissue is in the range of 1850–3700 MBq. It depends on the remnant size and radioiodine uptake. In subsequent treatment for metastases, administered activity is in the range 3700–11100 MBq.

Paediatric population:

The use of radioiodine in children and adolescents has to be considered carefully, based upon clinical needs and assessing the risk/benefit ratio in this patient group. The activity to be administered to children and adolescents should be a fraction of the adult dose calculated according to child body weight/age. There should be borne in mind that the late udesirable effects connected with sodium iodide [¹³¹I] administration in children (esspecialy under 10 years) and adolescents are more probably compared with the adults.

For detailed information on dosage and method of administration please refer to the Summary of Product Characteristics.

Shelf life:

28 days from the production date.

Special precautions for storage:

Store below 25°C.
Store in original lead shielding container.

Storage should be in accordance with national regulations for radioactive materials.

Nature and content of container:

The 10 mL glass vial (type I) closed with a rubber stopper and aluminum cap and placed in a shielding lead container.