Source: Health Products Regulatory Authority (IE) Revision Year: 2016 Publisher: biosyn Arzneimittel GmbH, Schorndorfer Str. 32, D–70734 Fellbach, Germany
Proven selenium deficiency that cannot be offset from food sources.
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 drinking bottle = 500 micrograms, respectively).
Detach a single-dose ampoule from the remainder of the strip of ampoules and open the oral ampoule by twisting the top. Squeeze out the whole of the contents of the ampoule into the mouth.
In the case of the drinking bottles:
Picture 1:
Picture 2:
Picture 3:
Picture 1: Before use the drinking bottle has to be made ready for use. For opening the screw cap is first turned clockwise down in order to open the drinking bottle with the integrated spike of the screw cap.
Picture 2: Then the screw cap is turned off anti-clockwise.
Picture 3: The complete contents is placed in the mouth or the required dose is removed by carefully squeezing of the drinking bottle into the enclosed measuring cup with milliliter graduation. Then the drinking bottle is closed firmly.
Hold the liquid in the mouth for about 30–60 seconds before swallowing.
Selenium levels in whole blood or serum should be determined in order to monitor the success of treatment.
There is no time limit to the administration of selesyn in a supplementary dose (100 micrograms selenium per day is equivalent to 1 ampoule).
2 µg/kg body weight/day at therapy onset and a maintenance dose of 1 µg/kg body weight/day.
For measuring a children’s dose of less than 1 ml oral solution approximately 5 ml oral solution is placed in the measuring cup and the needed volume is drawn up with the enclosed pipette. For example for a 1-year-old child with 10 kg body weight the maintenance dose is 10 µg per day corresponding to 0.2 ml oral solution. 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 (µg selenium/day) |
---|---|
1-3 | 60 |
4-6 | 90 |
7-10 | 130 |
11-14 | 200 |
15-17 | 250 |
No scientific evidence exists which would require dosage adjustment in patients with renal or hepatic impairment.
There is no scientific evidence on dosage adjustment in patients with renal or hepatic impairment.
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.
Unopened: 30 months.
Use immediately after opening. Discard any unused contents.
Do not store above 25°C.
Drinking bottles of plastic (LDPE) each containing 10 ml of oral solution with a PP screw cap, a measuring cup and a dosing pipette.
Pack sizes: 10, 20, 50.
Not all pack sizes may be marketed.
No special requirements.
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