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

Source: Health Products Regulatory Authority (IE)  Revision Year: 2016  Publisher: biosyn Arzneimittel GmbH, Schorndorfer Str. 32, 70734 Fellbach, Germany

4.1. Therapeutic indications

Proven selenium deficiency that cannot be offset from food sources.

4.2. Posology and method of administration

Daily dose

100–200 micrograms selenium (equivalent to 1-2 ampoules). If more selenium is necessary to reach the normal blood level, this dose can be increased to 500 micrograms selenium (equivalent to 5 ampoules = 5 × 100 micrograms or 1 injection vial = 500 micrograms, respectively).

Method of administration

Selesyn is administered as an intramuscular or intravenous injection. Selenium levels in whole blood or serum should be determined in order to monitor the success of therapy.

When selesyn is administered as a supplement to general infusion solutions for total parenteral nutrition, a daily dose of 100 micrograms selenium (equivalent to 1 ampoule of selesyn) must be ensured.

There is no time limit to the administration of selesyn in a supplementary dose (100 micrograms selenium per day, equivalent to 1 injection ampoule of selesyn).

Dosage in children

2 ยตg/kg body weight/day at therapy onset and a maintenance dose of 1 ยตg/kg body weight/day. Selenium levels in whole blood or serum should be determined in order to monitor the success of therapy.

Maximum daily doses for children for a longer time:

Age (years) UL (ยตg selenium/day)
1-3 60
4-6 90
7-10 130
11-14 200
15-17 250

Dosage in special patient groups

No scientific evidence exists which would require dosage adjustment in patients with renal or hepatic impairment.

Dosage in patients with renal or hepatic impairment

There is no scientific evidence on dosage adjustment in patients with renal or hepatic impairment.

4.9. Overdose

Signs of an acute overdose are an odour of garlic on the breath, tiredness, nausea, diarrhoea and abdominal pain. Chronic overdose can affect growth of nails and hair and may lead to peripheral polyneuropathy.

Countermeasures include gastric lavage, forced diuresis or the administration of high doses of vitamin C. In the case of an extreme overdose (1,000–10,000 times the normal dose) an attempt should be made to eliminate the selenium by dialysis. Administration of dimercaprol is not recommended as the toxic effect of selenium is potentiated.

6.3. Shelf life

Unopened: 4 years.

Use immediately after opening.

6.4. Special precautions for storage

This product does not require any special storage conditions.

6.5. Nature and contents of container

Injection ampoules each containing 2 ml of solution for injection are made of glass (Ph. Eur. Type I).

Pack sizes: 5, 10, 50.

Not all pack sizes may be marketed.

6.6. Special precautions for disposal and other handling

For single use only. Discard any unused contents.

Selesyn may be mixed with 0.9% NaCl.

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