Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
INFUSION, SOLUTION CONCENTRATE
**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.
INTRAVENOUS
Medical Information
**4.1. Therapeutic indications** Selenium supplementation during parenteral nutrition. Treatment of selenium deficiency which cannot be compensated by nutrition.
**4.3. Contraindications** Hypersensitivity to the active substance
A12CE02
sodium selenite
Manufacturer Information
AGUETTANT ASIA PACIFIC PTE. LTD.
Laboratoire AGUETTANT
Active Ingredients
Documents
Package Inserts
Selenium Aguettant Concentrate for IV Infusion PI.pdf
Approved: August 27, 2023