Selenium

Prevention of selenium deficiency in patients receiving parenteral nutrition. Treatment of proven selenium deficiency that cannot be compensated by nutrition alone.

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: o Supplementation to total parenteral nutrition: 60 to 100 micrograms daily. o 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: o Supplementation to total parenteral nutrition o Infants: 2 micrograms/kg/day and infants with low birth weight: 2 to 3 micrograms/kg/day. o Children: 2 micrograms/kg/day, up to a maximum of 30 micrograms daily.

o Adolescents: no data are available. 9% or glucose 5%) with a slow infusion rate.

No adverse effects are observed in normal conditions of use. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

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This product must not be administrated in case of hypersensitivity to selenium containing products.