SELENIUM AGUETTANT CONCENTRATE FOR SOLUTION FOR INFUSION 10 MCGML

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Sodium selenite eqv to Selenium

Available from:

AGUETTANT ASIA PACIFIC PTE. LTD.

ATC code:

A12CE02

Pharmaceutical form:

INFUSION, SOLUTION CONCENTRATE

Composition:

Sodium selenite eqv to Selenium 10 mcg/mL

Administration route:

INTRAVENOUS

Prescription type:

Prescription Only

Manufactured by:

Laboratoire AGUETTANT

Authorization status:

ACTIVE

Authorization date:

2023-08-27

Summary of Product characteristics

SELENIUM AGUETTANT
CONCENTRATE FOR SOLUTION FOR INFUSION 10 MICROGRAMS/ML
Selenium
1. NAME OF THE MEDICINAL PRODUCT
SELENIUM AGUETTANT concentrate for solution for infusion 10
micrograms/ml
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 10 ml vial contains 100 micrograms of selenium as sodium selenite
(219 micrograms).
Each ml of solution contains 10 micrograms of selenium as sodium
selenite (21.9 micrograms).
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Concentrate for solution for infusion. Clear, colourless solution.
pH between 8.0 and
9.5
.
4. CLINICAL PARTICULARS
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