SELENIUM AGUETTANT CONCENTRATE FOR SOLUTION FOR INFUSION 10 MCG/ML [SIN16847P]

Product Info

SELENIUM AGUETTANT CONCENTRATE FOR SOLUTION FOR INFUSION 10 MCG/ML

[SIN16847P]

4.1. Therapeutic indications
Selenium supplementation during parenteral nutrition.
Treatment of selenium deficiency which cannot be compensated by nutrition.

4.2. Posology and method of administration
Posology
1 ml of solution contains 10 micrograms of selenium.
The dose must be adjusted according to the needs of the patient.
The recommended dosage is:
Adults:

• Total parenteral nutrition: 60 to 100 micrograms daily.

• Selenium deficiency: 100 micrograms (up to a maximum of 400 micrograms) daily for a short period until normalisation of laboratory tests.

Paediatric population:

• Total parenteral nutrition:

  • Infants: 2 micrograms/kg/day and infants with low birth weight: 2 to 3 micrograms/kg/day.

  • Children: 2 to 3 micrograms/kg/day, up to a maximum of 30 micrograms daily.

  • Adolescents: no data are available.

• Selenium deficiency: no data are available

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.
The dose must be adjusted to each individual as a function of the selenium deficiency and the selenium status.
Method of administration
Administration by intravenous route:
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.

4.3. Contraindications
Hypersensitivity to the active substance