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.

Qualitative and quantitative compositions:

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.

Excipients with known effect:

One hard capsule contains maximum 97 mg sodium per capsule. One hard capsule contains quinolone yellow (E 104) 0.2% per capsule shell.

Pharmaceutical form:

Hard capsule.

Medium orange hard gelatin capsule, approximately 18 mm long, containing white powder.

List of excipients:

Capsule contents:

Sodium carbonate

Sodium hydrogen carbonate

Sodium hydroxide

Disodium phosphate dihydrate

Sodium thiosulfate

Gelatin capsule shell composition:

Quinoline yellow (E 104)

Erythrosine (E 127)

Titanium dioxide (E 171)

Gelatin

Posology and method of administration:

This medicinal product should be administered only by authorised healthcare professionals in designated clinical settings.

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

Shelf life:

21 days from the manufacturing date.

Special precautions for storage:

Store below 25°C.
Store in the original package to avoid radiation exposure from the product.

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

Nature and content of container:

The polypropylene vial placed in a shielding lead container, closed with a lead stopper which contains polypropylene insert with iodine absorber.

The package contains a single capsule. Each package is accompanied by a separate polypropylene applicator for capsule administration.