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HSA Approval

SELENIUM AGUETTANT CONCENTRATE FOR SOLUTION FOR INFUSION 10 MCG/ML

SIN16847P

SELENIUM AGUETTANT CONCENTRATE FOR SOLUTION FOR INFUSION 10 MCG/ML

SELENIUM AGUETTANT CONCENTRATE FOR SOLUTION FOR INFUSION 10 MCG/ML

August 27, 2023

AGUETTANT ASIA PACIFIC PTE. LTD.

AGUETTANT ASIA PACIFIC PTE. LTD.

Regulatory Information

HSA regulatory responsibility and product classification details

Regulatory Responsibility

RegistrantAGUETTANT ASIA PACIFIC PTE. LTD.
Licence HolderAGUETTANT ASIA PACIFIC PTE. LTD.

Product Classification

D
Drug Type
Therapeutic
F
Forensic Class
Prescription Only
HSA Singapore 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

Sodium selenite eqv to Selenium

10 mcg/mL

Selenious acid

Documents

Package Inserts

Selenium Aguettant Concentrate for IV Infusion PI.pdf

Approved: August 27, 2023

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