- Approval Id
- e165aba816e17afe
- Drug Name
- SELENIUM AGUETTANT CONCENTRATE FOR SOLUTION FOR INFUSION 10 MCG/ML
- Product Name
- SELENIUM AGUETTANT CONCENTRATE FOR SOLUTION FOR INFUSION 10 MCG/ML
- Approval Number
- SIN16847P
- Approval Date
- 2023-08-27
- Registrant
- INTEGA PTE LTD
- Licence Holder
- INTEGA PTE LTD
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- INFUSION, SOLUTION CONCENTRATE
- Dosage
- <p><strong>4.2. Posology and method of administration</strong><br>
<strong><u>Posology</u></strong><br>
1 ml of solution contains 10 micrograms of selenium.<br>
The dose must be adjusted according to the needs of the patient.<br>
<strong>The recommended dosage is:</strong><br>
<u>Adults:</u></p>
<ul>
<li>Total parenteral nutrition: 60 to 100 micrograms daily.</li>
<li>Selenium deficiency: 100 micrograms (up to a maximum of 400 micrograms) daily for a short period until normalisation of laboratory tests.</li>
</ul>
<p><u>Paediatric population:</u></p>
<ul>
<li>Total parenteral nutrition:
<ul class="dash">
<li>Infants: 2 micrograms/kg/day and infants with low birth weight: 2 to 3 micrograms/kg/day.</li>
<li>Children: 2 to 3 micrograms/kg/day, up to a maximum of 30 micrograms daily.</li>
<li>Adolescents: no data are available.</li>
</ul>
</li>
<li>Selenium deficiency: no data are available</li>
</ul>
<p>Selenium serum levels must be monitored regularly (every 6 to 12 months) in long-term parenteral nutrition and in case of renal impairment or more frequently in case of clinical signs of deficiency.<br>
The dose must be adjusted to each individual as a function of the selenium deficiency and the selenium status.<br>
<u><strong>Method of administration</strong></u><br>
Administration by intravenous route:<br>
SELENIUM AGUETTANT concentrate for solution for infusion 10 micrograms/ml must be administered after dilution in solution for parenteral nutrition, after the stability has been validated, or in an isotonic solution (such as 0.9% sodium chloride or 5% glucose) with a slow infusion rate.</p>
- Route Of Administration
- INTRAVENOUS
- Indication Info
- <p><strong>4.1. Therapeutic indications</strong><br>
Selenium supplementation during parenteral nutrition.<br>
Treatment of selenium deficiency which cannot be compensated by nutrition.</p>
- Contraindications
- <p><strong>4.3. Contraindications</strong><br>
Hypersensitivity to the active substance</p>
- Atc Code
- A12CE02
- Atc Item Name
- sodium selenite
- Pharma Manufacturer Name
- AGUETTANT ASIA PACIFIC PTE. LTD.
