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.
Selenase 500 micrograms, solution for injection (50 micrograms/ml)
⚠ 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 pentahydrate 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
Selenase® solution for injection is a medicinal product which belongs to the group of the mineral supplements. Sodium selenite pentahydrate, the active substance in your solution for injection, provides a source of selenium, which is an essential trace element in nutrition to ensure that your metabolism functions efficiently. Your doctor will have recommended this medicine because tests to measure the selenium levels in your blood have shown that you have a selenium deficiency, which cannot be corrected by selenium intake from food sources.
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2.
BEFORE YOU USE SELENASE® SOLUTION FOR INJECTION
Do not use Selenase® solution for injection
- if you are allergic (hypersensitive) to sodium selenite pentahydrate or any of the other ingredients of Selenase® solution for injection.
- if you have a selenosis (selenium poisoning). Take special care with Selenase® solution for injection There are no special warnings or precautions for the use of Selenase® solution for injection. Using other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. It must be ensured that the solution is not mixed with reducing substances (e.g. vitamin C). Pregnancy and breast-feeding Ask your doctor or pharmacist for advice before taking any medicine. Pregnancy: There are no data from the use of Selenase® solution for injection in pregnant women. No adverse effect of sodium selenite on the pregnancy or the unborn child is expected, provided that it is used in case of proven selenium deficiency. Breast-feeding: Selenium is excreted into the breast milk. But doses correcting selenium deficiency in breast-feeding women are not expected to exert adverse effects on the breast-feeded infant. Driving and using machines There is no effect on the ability to drive and use machines. Important information about some of the ingredients of Selenase® solution for injection Selenase® solution for injection contains less than 1 mmol sodium (23 mg) per ml, therefore it is essentially "sodium free". 3.
How to take it
SELENASE® SOLUTION FOR INJECTION
Always use medicinal products exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Selenase® solution for injection is for single use only. The usual daily dose is: 100 – 200 micrograms selenium (equivalent to 1 to 2 ampoules Selenase® 100 micrograms, solution for injection or 2 – 4 ml Selenase® 500 micrograms, solution for injection). If the results from a blood test show that more selenium is required your doctor can increase the dose up to 500 micrograms selenium (equivalent to 5 ampoules Selenase® selenase® solution for injection, UK
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100 micrograms, solution for injection or 1 injection vial Selenase® 500 micrograms, solution for injection). Method of administration: Selenase® solution for injection is always administered to you by a nurse or a doctor. Selenase® solution for injection is administered as an intramuscular (injection into the muscles) or intravenous (injection into a vein) injection. Duration of treatment: Samples of your blood will be taken from time to time and used to determine the levels of selenium in your blood in order to monitor the success of your treatment. As soon as your selenium levels will be normal your treatment with Selenase® solution for injection will be finished. Dosage in children If you are a child your doctor will prescribe you a dose of 2 μg/kg body weight per day at therapy onset and a maintenance dose of 1 μg/kg body weight per day. Samples of your blood will be taken from time to time and used to determine the levels of selenium in your blood in order to monitor the success of your treatment. In the table below you can find the maximum daily doses for children for a longer time: Age (years) Tolerable Upper Intake Level (μg selenium/day) 1-3 60 4-6 90 7-10 130 11-14 200 15-17 250 Dosage in patients with renal or hepatic impairment: Your doctor will not prescribe a different dose if you have renal or hepatic impairment. If you use more Selenase® solution for injection than you should If you use more Selenase® solution for injection than you should the following symptoms may occur: • •
acute (short-term): odour of garlic on the breath, tiredness, nausea, diarrhoea and abdominal pain or chronic (long-term) what can affect the growth of nails and hair and may lead to peripheral polyneuropathy (a disorder of a nerve or nervous pathway that may be associated with numbness or tingling).
If you forget to use Selenase® solution for injection Do not use a double dose to make up for a forgotten injection. If you stop using Selenase® solution for injection There are no special instructions, if you stop using Selenase® solution for injection. If you have any further questions on the use of this product, ask your doctor or pharmacist.
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4.
POSSIBLE SIDE EFFECTS
Like all medicines, Selenase® solution for injection can cause side effects, although not everybody gets them. Frequency not known (cannot be estimated from the available data): After intramuscular administration you may feel pain at the place, where your nurse or doctor has administered Selenase® solution for injection. However, if you are given too much, the symptoms listed in the above section may be experienced. Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any
Possible side effects
not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard By reporting side effects you can help provide more information on the safety of this medicine. 5.
How to store it
SELENASE® SOLUTION FOR INJECTION
Keep out of the reach and sight of children. The nurse or doctor will administer you this medicine immediately after opening the ampoules or the vials. The nurse or doctor will not administer you this medicine if the ampoule or the vial is damaged or if the solution is cloudy. This medicinal product does not require any special storage conditions. Do not use Selenase® solution for injection after the expiry date which is stated on the label on the ampoule or the vial and on the carton after "EXP". The expiry date refers to the last day of that month. 6.
FURTHER INFORMATION
What Selenase® solution for injection contains The active substance is: Sodium selenite pentahydrate The other ingredients are: Sodium chloride, hydrochloric acid, water for injections –
Selenase® 100 micrograms, solution for injection: Each 2 ml injection ampoule contains 100 micrograms selenium in the form of 333 micrograms sodium selenite pentahydrate, corresponding to 50 micrograms/ml.
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–
Selenase® 500 micrograms, solution for injection: Each 10 ml injection vial contains 500 micrograms selenium in the form of 1,665 micrograms sodium selenite pentahydrate, corresponding to 50 micrograms/ml.
What Selenase® solution for injection looks like and contents of the pack What Selenase® solution for injection looks like: Selenase® solution for injection is a clear and colourless solution. Contents of the pack: Selenase® 100 micrograms, solution for injection: Injection ampoules each containing 2 ml of injection solution are made of glass. Pack sizes: 5, 10 and 50. –
Selenase® 500 micrograms, solution for injection: Injection vials each containing 10 ml of solution for injection are made of clear, colourless glass closed with steel blue chlorobutyl rubber stopper, aluminium flip-off cap with natural coloured PP disc or closed with grey bromobutyl rubber stopper, aluminium flip-off cap with grey PP disc. Pack sizes: 2 and 10.
Not all pack sizes may be marketed. Marketing Authorisation Holder: Kora Corporation Ltd. t/a Kora Healthcare 20 Harcourt Street Dublin 2, D02 H364 Ireland Manufacturer: biosyn Arzneimittel GmbH Schorndorfer Strasse 32 70734 Fellbach Germany
This medicinal product is authorised in the Member States of the EEA under the following names: NL: selenase oplossing voor injectie 100 μg, oplossing voor injectie 50 μg/ml selenase oplossing voor injectie 500 μg, oplossing voor injectie 50 μg/ml CZ: selenase inječní roztok 500 μg, inječní roztok 50 μg/ml HU: selesyn 100 microgramm, oldatos injekció selesyn 500 microgramm, oldatos injekció IE: selesyn 100 micrograms/2 ml solution for injection (50 micrograms/ml) selesyn 500 micrograms/10 ml solution for injection (50 micrograms/ml) IT: selesyn 100 mcg soluzione iniettabile selesyn 500 mcg soluzione iniettabile PT: selenase solução injectável 100 microgramas selenase solução injectável 500 microgramas SK: selenase inječný roztok 100 μg, inječný roztok 50 μg/ml selenase inječný roztok 500 μg, inječný roztok 50 μg/ml UK: selenase 100 micrograms, solution for injection (50 micrograms/ml) selenase® solution for injection, UK
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selenase 500 micrograms, solution for injection (50 micrograms/ml) This leaflet was last approved in 08/2023.
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Further information for the medicinal staff When preparing an infusion solution with Selenase® solution for injection 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 Selenase® solution for injection. Elemental selenium is not soluble in an aqueous medium and has no biological availability. When Selenase® solution for injection is administered as a supplement to general infusion solutions for total parenteral nutrition, a daily dose of 100 micrograms selenium (1 ampoule Selenase® 100 micrograms, solution for injection) must be ensured. There is no time limit to the administration of Selenase® solution for injection in a supplementary dose (100 micrograms selenium per day = 1 ampoule Selenase® 100 micrograms, solution for injection). Selenium levels in the whole blood or serum should be determined in order to monitor the success of the therapy. Selenase® solution for injection may be mixed with 0.9% NaCl. This medicinal product does not require any special storage conditions. The shelf-life of Selenase® solution for injection in the unopened ampoules or vials is 4 years. Discard any unused contents.
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Frequently asked questions about Selenase 500 micrograms, solution for injection (50 micrograms/ml)
How do I take Selenase 500 micrograms, solution for injection (50 micrograms/ml)?
Selenase 500 micrograms, solution for injection (50 micrograms/ml) comes as injection containing 500mcg / 50micrograms/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 Selenase 500 micrograms, solution for injection (50 micrograms/ml)?
The active substance in Selenase 500 micrograms, solution for injection (50 micrograms/ml) is sodium selenite pentahydrate.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Selenase 500 micrograms, solution for injection (50 micrograms/ml), 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 Selenase 500 micrograms, solution for injection (50 micrograms/ml) 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 pentahydrate
- 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
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 x 100 micrograms or 1 injection vial = 500 micrograms, respectively).
Method of administration
selenase® solution for injection 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 selenase® solution for injection 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 selenase® solution for injection 100 micrograms) must be ensured.
There is no time limit to the administration of selenase® solution for injection in a supplementary dose (100 micrograms selenium per day, equivalnet to 1 injection ampoule of selenase® solution for injection 100 micrograms).
Dosage in children
2 µg/kg body weight/day at therapy onset and a maintenance dose of 1 µg/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)
1-3
4-6
7-10
11-14
15-17
UL (µg selenium/day)
60
90
130
200
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.
4.3. Contraindications
Hypersensitivity to any component of the product (active substance or excipients).
Selenosis.
4.4. Special warnings and precautions for use
selenase® solution for injection contains less than 1 mmol sodium (23 mg) per ml, therefore it is essentially „sodium free“.
4.5. Interaction with other medicinal products and other forms of interaction
When preparing an infusion solution with selenase® solution for injection 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.
4.6. Pregnancy and lactation
Pregnancy
There are no data from the use of selenase® 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.
4.7. Effects on ability to drive and use machines
None.
4.8. Undesirable effects
'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
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
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.
💬 Ask about this leaflet
Ask anything about Selenase 500 micrograms, solution for injection (50 micrograms/ml). 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.