Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
CAPSULE
**Dose and Administration** The capsules are for oral administration and the dose ranges usually employed are as follows: Thyrotoxicosis150–600 MBq Thyroid ablation800–2000 MBq Thyroid carcinoma2000–6000 MBq (in two capsules)
ORAL
Medical Information
**Indications** Sodium Iodide (131I) Therapy Capsules are indicated in the treatment of hyperthyroidism, and the detection and ablation of residual functioning thyroid tissue in differentiated thyroid carcinoma.
**Contraindications** The use of this therapeutic radiopharmaceutical is absolutely contraindicated in women who are pregnant. Women of reproductive age should have a negative pregnancy test at the time of radionuclide therapy, and should take appropriate contraceptive measures. The use of therapeutic iodine-131 is not recommended in persons with renal insufficiency, as delayed excretion will result in increased whole body radiation. This therapy is contraindicated in-patients who are being treated concurrently with thyroid hormone or antithyroid drugs, are vomiting or have diarrhoea. - **Note:** “Iodine allergy” is not a contraindication for use, because of the very small chemical amounts of iodine in therapy capsules (e.g. approx. 3 microgram in a 500 MBq capsule).
V10XA01
sodium iodide (131I)
Manufacturer Information
TRANSMEDIC PTE LTD
ANSTO
Active Ingredients
Documents
Package Inserts
ANSTO Sodium Iodide Therapy Capsules 50 to 6000 MBq Approved PI.pdf
Approved: March 8, 2021