SELESYN Solution for injection Ref.[49864] Active ingredients: Sodium selenite

Selesyn contains less than 1 mmol sodium (23 mg) per ml, therefore it is essentially “sodium free”.

When preparing an infusion solution with Selesyn as a supplement, it must be ensured that the pH value does not fall below 7.0 and that the solution is not mixed with reducing substances (e.g. vitamin C), as a precipitate of elemental selenium may possibly result (see section 6.2 “Incompatibilities”). Elemental selenium is not soluble in an aqueous medium and has no biological availability.

Pregnancy

There are no data from the use of Selesyn in pregnant woman. Limited published data from animal studies reveal only evidence for toxicity to reproduction at maternally toxic dose.

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.

Lactation

Selenium is excreted in breast milk. Doses correcting selenium deficiency in breast feeding woman are not expected to exert adverse effects on the suckling infant.

None.

General disorders and administration site conditions

Frequency not known (cannot be estimated from the available data): After intramuscular administration local pain has been reported.

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. Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance, Earlsfort Terrace, IRL – Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie.

When preparing an infusion solution with Selesyn as a supplement, it must be ensured that the pH value does not fall below 7.0 and that the solution is not mixed with reducing substances (e.g. vitamin C), as a precipitate of elemental selenium may possibly result. On grounds of safety, non-specific precipitation should be avoided after mixing infusion solutions with Selesyn.