Therapeutic indications:

This medicinal product is for diagnostic use only.

This product is used for 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 normal thyroid parenchyma) nodules.

Sodium iodide Na¹³¹I POLATOM, capsules for diagnostic use may be used to study radioiodine location in thyroid tissue. An estimation of the thyroid uptake and its effective half-life can be used to calculate the dose absorbed from the activity of radioiodine planned for therapy.

Sodium iodide Na¹³¹I POLATOM, capsules for diagnostic use is also used in the management of patients with differentiated thyroid carcinoma to identify the remaining thyroid tissue and in the metastases diagnostics.

Qualitative and quantitative compositions:

Single hard capsule contains sodium iodide [¹³¹I] Natrii iodidi (¹³¹I) radioactivity range [1–37 MBq].

Iodine-131 is obtained by neutron irradiation of tellurium in a nuclear reactor or by extraction from uranium fission products. Iodine-131 has a half-life of 8.02days. It decays to stable xenon-131, by emission of gamma radiations of 365 keV (81.7%), 637 keV (7.2%) and 284 keV (6.1%) and beta radiation of maximal energy of 606 keV.

Pharmaceutical form:

Hard capsules.

List of excipients:

Sodium carbonate

Sodium hydrogen carbonate

Disodium hydrogen phosphate dihydrate

Sodium thiosulphate pentahydrate

Hard gelatin capsule

Posology and method of administration:

Sodium iodide Na¹³¹I POLATOM, capsules for diagnostic use is a medicinal product for oral administration.

The recommended activities for an adult patient (70 kg) are as follows:

• • • for the scyntygraphic thyroid diagnosis and thyroid uptake studies: 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 capsule administration and then again in the first few days.
    • for diagnosis in patients treated for thyroid differentiated carcinoma (for metastases and 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 activity administered should in every case be as low as reasonably achievable to obtain the required diagnostic information.

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. 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.

The diagnostic activities to be administered to children should be a fraction of the adult dose calculated from the body weight/surface area methods according to the following equations:

[Paediatric dose (MBq) = Adult dose (MBq) x child weight (kg)] / 70 kg

[Paediatric dose (MBq) = Adult dose (MBq) x child surface (m²)] / 1.73

Correction factors given for guidance are proposed below (in accordance with Paediatric Task Group of European Association of Nuclear Medicines recommendations).

Fraction of adult dose

3 kg = 0.1

4 kg = 0.14

6 kg = 0.19

8 kg = 0.23

10 kg = 0.27

12 kg = 0.32

14 kg = 0.36

16 kg = 0.40

18 kg = 0.44

20 kg = 0.46

22 kg = 0.50

24 kg = 0.53

26 kg = 0.56

28 kg = 0.58

30 kg = 0.62

32 kg = 0.65

34 kg = 0.68

36 kg = 0.71

38 kg = 0.73

40 kg = 0.76

42 kg = 0.78

44 kg = 0.80

46 kg = 0.82

48 kg = 0.85

50 kg = 0.88

52–54 kg = 0.90

56–58 kg = 0.92

60–62 kg = 0.96

64–66 kg = 0.98

68 kg = 0.99

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

Shelf life:

21 days from the production date.

Special precautions for storage:

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

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

Nature and content of container:

Gelatin capsules for diagnostic use are provided in the two types of direct packaging:

First type of packaging:

the polypropylene vial closed with a polyethylene stopper, placed in a shielding lead container. Single vial may contain up to 10 capsules of the same radioactivity. Each box is accompanied by a radioactive source certificate.

Second type of packaging:

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 for capsule administration and radioactive source certificate.