- Approval Id
- d02bcf4b596c3c83
- Drug Name
- ANSTO - SODIUM IODIDE [131I] THERAPY CAPSULES (50 TO 6000 MBQ)
- Product Name
- ANSTO - SODIUM IODIDE [131I] THERAPY CAPSULES (50 TO 6000 MBQ)
- Approval Number
- SIN16117P
- Approval Date
- 2021-03-08
- Registrant
- TRANSMEDIC PTE LTD
- Licence Holder
- TRANSMEDIC PTE LTD
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- CAPSULE
- Dosage
- <p><strong>Dose and Administration</strong><br>
The capsules are for oral administration and the dose ranges usually employed are as follows:</p>
<table class="borderless-100">
<tbody>
<tr>
<td>Thyrotoxicosis</td>
<td>150–600 MBq<br><br></td>
</tr>
<tr>
<td>Thyroid ablation</td>
<td>800–2000 MBq<br><br></td>
</tr>
<tr>
<td>Thyroid carcinoma</td>
<td>2000–6000 MBq<br>(in two capsules)<br><br></td>
</tr>
</tbody>
</table>
- Route Of Administration
- ORAL
- Indication Info
- <p><strong>Indications</strong><br>
Sodium Iodide (<sup>131</sup>I) Therapy Capsules are indicated in the treatment of hyperthyroidism, and the detection and ablation of residual functioning thyroid tissue in differentiated thyroid carcinoma.</p>
- Contraindications
- <p><strong>Contraindications</strong><br>
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.</p>
<p>The use of therapeutic iodine-131 is not recommended in persons with renal insufficiency, as delayed excretion will result in increased whole body radiation.</p>
<p>This therapy is contraindicated in-patients who are being treated concurrently with thyroid hormone or antithyroid drugs, are vomiting or have diarrhoea.</p>
<ul class="nobull">
<li><p><strong>Note:</strong> “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).</p></li>
</ul>
- Atc Code
- V10XA01
- Atc Item Name
- sodium iodide (131I)
- Pharma Manufacturer Name
- TRANSMEDIC PTE LTD
- Company Detail Path
- /organization/transmedic-pte-ltd
