Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Laboratoire Aguettant, 1, rue Alexander Fleming, 69007, Lyon, France
This product must not be administrated in case of hypersensitivity to selenium containing products.
The product must not be injected straight, but diluted in a solution for infusion (see section 4.2).
Serum selenium levels must be controlled regularly.
In case of complex parenteral nutrition and if mixing of medicines is necessary, caution is required in order to avoid incompatibilities.
This medicine contains less than 1 mmol sodium (23 mg) per 10 ml vial, that is to say essentially ‘sodium-free’.
No interaction studies have been performed.
There are no data from the use of Selenium in pregnant women. Limited published data from animal studies reveal only evidence for toxicity to reproduction at maternally toxic doses (see section 5.3.). No adverse effect of sodium selenite on the pregnancy or unborn child is expected, provided that it is used in case of proven selenium deficiency.
Selenium is excreted in human milk, but at therapeutic doses of selenium no effects on the breastfed newborns/infants are anticipated. Selenium can be used during breast-feeding.
There are no data on fertility from the use of selenium in humans. Selenium did not impair male fertility in rats, and effects of selenium on female fertility in rodents were only observed at very high doses (see section 5.3). Overall, doses used to correct selenium deficiency are not expected to exert adverse effects on fertility.
SELENIUM 10 micrograms/ml concentrate for solution for infusion has no influence on the ability to drive and use machines.
No adverse effects are observed in normal conditions of use.
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. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme – Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Selenium is generally incompatible with high concentration of ascorbic acid (reduction of selenite to elemental selenium which is not soluble and unavailable as a nutritional source of selenium).
SELENIUM 10 micrograms/ml concentrate for solution for infusion can not be mixed with medicines except those mentioned in section 6.6.
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