- Approval Id
- eba4c5743e33fb65
- Drug Name
- SODIUM IODIDE NA131I POLATOM CAPSULE
- Product Name
- SODIUM IODIDE NA131I POLATOM CAPSULE
- Approval Number
- SIN15467P
- Approval Date
- 2018-04-23
- Registrant
- QUANTUM TECHNOLOGIES GLOBAL PTE. LTD.
- Licence Holder
- QUANTUM TECHNOLOGIES GLOBAL PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- CAPSULE
- Dosage
- <p><strong>4.2 Posology and method of administration</strong></p>
<p>Sodium iodide Na<sup>131</sup>I POLATOM, capsules for therapeutic use is a medicinal product with varying radioactivity, for oral administration.</p>
<p>The recommended therapeutic dose is a matter for clinical judgement. This dose should be established individually for each patient.</p>
<p><u>Adults:</u><br>
<u>Treatment of hyperthyroidism and nodular goitre:</u><br>
The activity administered is usually in the range of 200 – 800 MBq but repeated treatment may be necessary.<br>
The dose required depends on the diagnosis, the size of the gland, thyroid uptake and iodine clearance.<br>
Patients should be rendered euthyroid medically whenever possible before giving radioiodine treatment for hyperthyroidism.</p>
<p><u>For thyroid ablation and treatment of metastases:</u><br>
The administered activities following total or subtotal thyroidectomy to ablate remaining thyroid tissue are 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 – 11 100 MBq.</p>
<p>The therapeutic administration of sodium iodide (<sup>131</sup>I) capsules in patients with significant renal impairment, in which an activity adjustment is necessary, requires special attention. In order to reduce the absorbed radiation dose to the bladder walls (after high doses used e.g in thyroid tumours treatment), the patient should be encouraged to increase oral fluid intake to have frequent bladder emptying.</p>
<p>A low iodine diet in patients prior to therapy will enhance (<sup>131</sup>I) uptake into functioning thyroid tissue. It is recommended to keep the patient fasted for approximately 2 hours before and after swallowing the capsule for better thyroid uptake.</p>
<p><u>Paediatric population:</u><br>
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.</p>
<p>The therapeutic effect is only achieved after several months.</p>
- Route Of Administration
- ORAL
- Indication Info
- <p><strong>4.1 Therapeutic indications</strong></p>
<p>This product is used in the treatment of: thyroid nodular goitre, hyperthyroidism in the Graves-Basedow’s disease, autonomic nodule and the toxic multinodular goitre. It is used for the thyroid residue ablation after surgery of differentiated thyroid tumours and in the treatment of iodine-accumulating metastases.</p>
- Contraindications
- <p><strong>4.3 Contraindications</strong></p>
<p>Sodium iodide Na<sup>131</sup>I POLATOM, capsules for therapeutic use must not be used in the following cases:</p>
<ul>
<li>In women with established or suspected pregnancy or when pregnancy has not been excluded (see section 4.6 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</li>
<li>Breastfeeding women</li>
<li>Hypersensitivity to the active substance or to any of the excipients.</li>
</ul>
- Atc Code
- V10XA01
- Atc Item Name
- sodium iodide (131I)
- Pharma Manufacturer Name
- QUANTUM TECHNOLOGIES GLOBAL PTE. LTD.
