Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
SELENIUM 10 micrograms/ml concentrate for solution for infusion
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Sodium selenite may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for SELENIUM contains the active substance sodium selenite. It belongs to a group of mineral supplements and provides a nutritional source of selenium. Selenium is an essential trace element that ensures your metabolism functions efficiently. SELENIUM is used to: •P revent selenium deficiency in patients receiving parenteral nutrition (artificial feeding through a vein).
- Treat selenium deficiency that cannot be compensated by intake from food alone. SELENIUM can be used in adults and in children. Selenium is a trace element. It means your body needs only very small quantity of this nutriment. Selenium is essential for some of your organs (thyroid gland, liver, muscles), and your defence against risk of infection (immune system). Selenium also enhances the protection of your cell membranes against potential attack from diseases. Any selenium deficiency in your body might induce weakness of these organs or systems which could lead to tiredness, shortness of breath, muscular discomfort, abnormalities in nails or hair.
What you need to know before you take it
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Do not use SELENIUM: if you are allergic to selenium compounds. Warnings and precautions This medicine should not be injected without prior dilution. Your doctor will use SELENIUM with caution if you are being administered nutrition through a vein (parenteral nutrition) and need to be given other medicines at the same time. This will help avoid undesirable reactions. SELENIUM should not be administered at the same time as ascorbic acid (vitamin C). When these two substances are mixed, selenium can no longer be used by the body as a nutrition source. Other medicines and SELENIUM Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription. Pregnancy, breast-feeding and fertility If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. Pregnancy: The use of SELENIUM is not recommended during pregnancy, unless considered essential. Breast-feeding: 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. Fertility: 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. Overall, doses used to correct selenium deficiency are not expected to exert adverse effects on fertility. SELENIUM contains sodium This medicine contains less than 1 mmol sodium (23 mg) per 10 ml vial, that is to say essentially 'sodium-free'.
How to take it
SELENIUM This medicine will always be administered to you by a healthcare professional. Your doctor will determine the dose of SELENIUM based on your needs. Samples of your blood will be taken during treatment. Your doctor will monitor the level of selenium in your blood to ensure it does not exceed the recommended level. The recommended dose is: Adults
- To supplement total parenteral nutrition: 60 to 100 micrograms daily. •O ther situations with proven selenium deficiency: 100 micrograms up to a maximum of 400 micrograms daily. Treatment will be given until your selenium levels are normal.
Technical leaflet The following information is intended for healthcare professionals only This is an extract from the Summary of Product Characteristics to assist in the administration of Selenium Sterile concentrate. When determining appropriateness of use in a particular patient, the prescriber should be familiar with the Summary of Product Characteristics of the product.
Incompatibilities 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 cannot be mixed with medicines other than sodium chloride 0.9%, glucose 5%, solution for parenteral nutrition or solution of trace elements. Each ml of concentrate should be diluted in at least 5 ml of solution for infusion.
Paediatric population
- To supplement total parenteral nutrition:
- Infants: 2 micrograms/kg/day and infants with low birth weight: 2 to 3 micrograms/kg/day.
- Children: 2 micrograms/kg/day, up to a maximum of 30 micrograms daily.
- Adolescents: no data are available.
- Other situation with proven selenium deficiency: No data are available. Method of administration SELENIUM will be diluted before it is given to you as a slow infusion. Duration of administration The treatment duration will be determined by your doctor. If you use more SELENIUM than you should: Symptoms of acute (short-term) overdose are garlicky breath, tiredness, vomiting, diarrhoea and abdominal pain. In case of chronic (long-term) overdose, skin and hair and nails can be affected with changes in nail and hair growth and may lead to peripheral polyneuropathies (a nerve disorder that can result in numbness or tingling). In case of acute overdose by ingestion of large amount of selenium, treatment includes stomach pumping (gastric lavage) and forced diuresis. In case of extreme overdose (1,000 – 10,000x), elimination of selenite by dialysis can be tried. There is no specific antidote. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. There are no known side-effects in case of proper use. Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
How to store it
SELENIUM After dilution, chemical and physical in-use stability has been demonstrated for 48 h at 25°C. From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless dilution has taken place in controlled and validated aseptic conditions. Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton and vial label. The expiry date refers to the last day of that month. There are no specific storage conditions for this medicine. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
Contents of the pack and other information
What SELENIUM contains:
- The active substance is selenium. Each vial of 10 ml contains 100 micrograms of selenium as sodium selenite (219 micrograms). Each ml of solution contains 10 micrograms of selenium as sodium selenite (21.9 micrograms).
- The other ingredient is water for injection. What SELENIUM looks like and contents of the pack: SELENIUM is a clear, colourless solution for infusion in glass vial. Pack of 10 vials. Marketing Authorisation Holder: Laboratoire AGUETTANT 1, rue Alexander Fleming 69007 LYON France Manufacturer: Laboratoire AGUETTANT 1, rue Alexander Fleming 69007 LYON France Distributed by: AGUETTANT LTD Unit 1, Farleigh House – Flax Bourton BRISTOL, BS48 1UR England This leaflet was last revised in 05/2019.
Frequently asked questions about SELENIUM 10 micrograms/ml concentrate for solution for infusion
How do I take SELENIUM 10 micrograms/ml concentrate for solution for infusion?
SELENIUM 10 micrograms/ml concentrate for solution for infusion comes as infusion containing 10micrograms/ml. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in SELENIUM 10 micrograms/ml concentrate for solution for infusion?
The active substance in SELENIUM 10 micrograms/ml concentrate for solution for infusion is sodium selenite.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for SELENIUM 10 micrograms/ml concentrate for solution for infusion, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get SELENIUM 10 micrograms/ml concentrate for solution for infusion without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: sodium selenite
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Prevention of selenium deficiency in patients receiving parenteral nutrition.
Treatment of proven selenium deficiency that cannot be compensated by nutrition alone.
4.2. Posology and method of administration
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.
o Other situation with proven selenium deficiency: No data are available
Method of administration
Intravenous administration:
SELENIUM 10 micrograms/ml concentrate for solution for infusion must be administered after dilution in solution for parenteral nutrition, after stability has been validated, or in isotonic solution (such as sodium chloride 0.9% or glucose 5%) with a slow infusion rate.
4.3. Contraindications
This product must not be administrated in case of hypersensitivity to selenium containing products.
4.4. Special warnings and precautions for use
Special warnings:
The product must not be injected straight, but diluted in a solution for infusion (see section 4.2).
Precautions for use:
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.
Sodium:
This medicine contains less than 1 mmol sodium (23 mg) per 10 ml vial, that is to say essentially 'sodium-free'.
4.5. Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed.
4.6. Fertility, pregnancy and lactation
Pregnancy
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.
Lactation
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.
Fertility
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.
4.7. Effects on ability to drive and use machines
SELENIUM 10 micrograms/ml concentrate for solution for infusion has no influence on the ability to drive and use machines.
4.8. Undesirable effects
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. 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.
4.9. Overdose
Symptoms of acute overdose are: garlicky breath, tiredness, nausea and vomiting, diarrhoea and abdominal pain. In case of chronic overdose, effects on skin and skin appendages with changes in the nail and hair growth as well as peripheral polyneuropathies have been observed.
In case of overdose, the treatment must be interrupted, and a symptomatic treatment should be given if necessary. In case of acute overdose by ingestion of large amount of selenium, gastric lavage and forced diuresis are possible. In case of extreme overdose (1,000 – 10,000x), elimination of selenite by dialysis can be attempted. There is no known specific antidote. In case of intoxication, selenium blood levels should be controlled at least once a month, until return to a level conform to the recommendations.
💬 Ask about this leaflet
Ask anything about SELENIUM 10 micrograms/ml concentrate for solution for infusion. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.