SELENIUM Concentrate for solution for infusion Ref.[8601] Active ingredients: Sodium selenite

Posology

1 ml of solution contains 10 micrograms of selenium.

The dose must be adapted individually according to selenium deficiency and selenium status.

For monitoring of therapy the selenium concentration in whole blood or serum should be determined. In long term parenteral nutrition, control of blood levels should be performed at 6-12 months intervals, except if clinical symptoms of a deficiency are suspected.

Adults: Plasma selenium concentrations from 80 to 120 μ/L (in whole blood: 100 to 140 μg/l) have been proposed to be adequate in adults. At levels above the normal selenium levels, the dose should be reduced.

Paediatric population: Age specific reference values for normal selenium concentrations apply for monitoring of therapy.

The recommended posology is:

Adults:

• Supplementation to total parenteral nutrition: 60 to 100 micrograms daily.
• Other situation with proven selenium deficiency: 100 micrograms up to a maximum of 400 micrograms daily for a short-term until normalization of laboratory monitoring values.

Paediatric population:

• Supplementation to total parenteral nutrition
  • Infants: 2 micrograms/kg/day and infants with low birth weight: 2 to 3 micrograms/kg/day.
  • Children: 2 micrograms/kg/day, up to a maximum of 30 micrograms daily.
  • Adolescents: no data are available.
• Other situation with proven selenium deficiency: No data are available

Method of administration

Intravenous administration

SELENIUM 10 micrograms/ml concentrate for solution for infusion must be administered after dilution in solution for parenteral nutrition, after stability has been validated, or in isotonic solution (such as sodium chloride 0.9% or glucose 5%) with a slow infusion rate.

Symptoms of acute overdose are: garlicky breath, tiredness, nausea and vomiting, diarrhoea and abdominal pain. In case of chronic overdose, effects on skin and skin appendages with changes in the nail and hair growth as well as peripheral polyneuropathies have been observed.

In case of overdose, the treatment must be interrupted, and a symptomatic treatment should be given if necessary. In case of acute overdose by ingestion of large amount of selenium, gastric lavage and forced diuresis are possible. In case of extreme overdose (1,000–10,000x), elimination of selenite by dialysis can be attempted. There is no known specific antidote. In case of intoxication, selenium blood levels should be controlled at least once a month, until return to a level conform to the recommendations.

Shelf life: 3 years.

After dilution, chemical and physical in-use stability has been demonstrated for 48 h at 25°C.

From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.

There are no special storage conditions.

10 ml solution in a type I glass vial with a type I elastomer (bromobutyl) stopper fitted with an aluminium cover and crimped.

Pack of 10 vials.

SELENIUM 10 micrograms/ml concentrate for solution for infusion can not be mixed with medicines other than sodium chloride 0.9%, glucose 5%, solution for parenteral nutrition or solution of trace elements.

Each ml of concentrate should be diluted in at least 5 ml of solution for infusion. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.