Patient leaflet - Selenase 100 micrograms solution for injection (50 micrograms / ml)
1. WHAT SELENASE® SOLUTION FOR INJECTION IS AND WHAT IT IS USED FOR
selenase® solution for injection is a medicinal product which belongs to the group of the mineral supplements. Sodium selenite pentahy-drate, 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.
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 USE 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® 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 ( see reverse )
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.
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 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.
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® injekční roztok 500 µg, injekční 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® injekčný roztok 100 µg, injekčný roztok 50 µg/ml selenase® injekčný roztok 500 µg, injekčný roztok 50 µg/ml UK: selenase® 100 micrograms, solution for injection
(50 micrograms/ml)
selenase® 500 micrograms, solution for injection
(50 micrograms/ml)
This leaflet was last approved in 08/2023.
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 supple-ment 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.
Tx-XXXXX · 175-04 · November 2023