Solution 50 micrograms/ml Selenium solution for injection
(as sodium selenite pentahydrate)
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What Selesyn is and what it is used for
Selesyn is a drug that belongs to the group of mineral supplements. Sodium selenite pentahydrate, the active substance in Selesyn, is a source of selenium which is an important trace element in nutrient intake to ensure efficient metabolism.
Selesyn is used for adults.
Your doctor has recommended this medicine because tests to measure the level of selenium in your blood have shown that you have a selenium deficiency that cannot be corrected by selenium intake through your diet.
Sodium selenite pentahydrate contained in Selesyn may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before using Selesyn
Do not use Selesyn
- if you are allergic to sodium selenite pentahydrate or any of the other ingredients of this medicine (listed in section 6).
- if you have selenosis (selenium poisoning). For symptoms of selenosis, see section 3 “If you have had too much Selesyn”.
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before taking Selesyn.
Children and young people
Do not give this medicine to children under 18 years of age as safety and efficacy have not been established.
Other medicines and Selesyn
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
The solution for injection must not be mixed with so-called reducing agents such as vitamin C.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
There is limited information on the use of sodium selenite pentahydrate in pregnant women. No adverse effects of sodium selenite pentahydrate are expected on pregnancy or the unborn child, provided that the medicine is used in case of proven selenium deficiency.
Breast-feeding
Selenium is excreted in breast milk. However, at approved doses of Selesyn, no effects on breastfed newborns/infants are expected.
Fertility
There is no information available on the role of selenium in fertility.
Driving and using machines
There is no effect on the ability to drive and use machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Selesyn solution for injection/infusion contains sodium
Selesyn 100 micrograms, solution for injection or infusion
This medicine contains less than 1 mmol sodium (23 mg) per 2 ml ampoule, ie essentially ‘sodium-free’.
Selesyn 50 micrograms/ml, solution for injection or infusion
This medicine contains up to 35.70 mg and 71.39 mg of sodium respectively (the main ingredient in table salt/table salt) in each vial of 10 ml and 20 ml respectively. This corresponds to 1.8% and 3.6%, respectively, of the highest recommended daily intake of sodium for adults.
How to take Selesyn
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
Selesyn 100 micrograms solution for injection/infusion is used as a single dose only.
The recommended dose for adults is:
100 micrograms selenium (1 ampoule Selesyn 100 micrograms solution for injection / infusion or 2 ml from 10 ml or 20 ml vial Selesyn 50 micrograms / ml solution for injection / infusion) daily. For a short time, up to 300 micrograms of selenium (3 ampoules of Selesyn 100 micrograms solution for injection or infusion or 6 ml from a 10 ml or 20 ml vial of Selesyn 50 micrograms/ml solution for injection/infusion) can be given daily.
To treat extreme selenium deficiency, your doctor may temporarily increase the dose by up to 2000 micrograms of selenium (2 vials of 20 ml Selesyn 50 micrograms/ml solution for injection/infusion) daily.
Use
Selesyn, the solution for injection/infusion should always be given to you by a nurse or doctor.
Selesyn, a solution for injection or infusion, is given intramuscularly ( injection into a muscle) or intravenously ( injection into a vein), or as an additive to infusion.
Duration of treatment:
How long you should be treated is decided by your doctor.
Your nurse or doctor will take regular blood tests to check the levels of selenium in your blood to monitor the effectiveness of your treatment. As soon as the selenium content is normal, your treatment with Selesyn will be completed.
Selesyn should only be given when oral administration is not possible.
If you have had too much Selesyn
If you have had more Selesyn than you should, you may experience the following symptoms:
- acute (short-term): garlic-smelling breath, fatigue, nausea, diarrhea, and abdominal pain or
- chronic (long-term): can cause symptoms that affect the growth of nails and hair and can lead to peripheral polyneuropathy (a disease of a nerve or nerve pathway that can feel numb or tingling).
If you forget to get Selesyn
Do not take a double dose to make up for a forgotten injection/infusion.
If you stop using Selesyn
There are no special instructions if you stop using Selesyn.
If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
No known frequency (cannot be calculated from the available data):
After intramuscular use, you may feel pain in the place where your nurse or doctor has given Selesyn.
Reporting
How to store Selesyn
Keep this medicine out of the sight and reach of children.
Selesyn is for single use only. Your nurse or doctor will give you this medicine immediately after opening the ampoule or bottle. Your doctor or nurse will inject the remaining 10 ml or 20 ml vial of Selesyn 50 micrograms/ml solution for injection/infusion.
Your nurse or doctor will not give you this medicine if the ampoule or bottle is damaged or if the solution is cloudy.
Do not use this medicine after the expiry date which is stated on the carton and the ampoule or vial label after “EXP”. The expiration date is the last day of the specified month.
No special storage instructions.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the packaging and other information
Content declaration
The active substance is: sodium selenite pentahydrate
Selesyn 100 micrograms, solution for injection or infusion, 2 ml
1 ampoule with 2 ml solution for injection/infusion contains: 0.333 mg sodium selenite pentahydrate, equivalent to 100 micrograms of selenium
Selesyn 50 micrograms / ml, solution for injection / infusion, 10 ml (500 micrograms)
One vial of 10 ml solution for injection/infusion contains 1.67 mg sodium selenite pentahydrate equivalent to 500 micrograms seof lenium.
Selesyn 50 micrograms / ml, solution for injection / infusion, 20 ml (1000 micrograms)
One vial of 20 ml solution for injection/infusion contains 3.33 mg sodium selenite pentahydrate equivalent to 1000 micrograms selenium.
The other ingredients are: sodium chloride, water for injections, hydrochloric acid
What the medicine looks like and the contents of the pack
Selesyn is a clear, colorless solution.
Selesyn 100 micrograms, solution for injection or infusion
Glass ampoule containing 2 ml solution for injection/infusion
Pack sizes: 5, 10, and 50 ampoules
Selesyn 50 micrograms/ml, solution for injection or infusion
Glass vial with chlorobutyl rubber stopper containing 10 ml or 20 ml solution for injection/infusion.
10 ml vial (500 micrograms)
Pack sizes: 2, 10 and 50 (5 x 10) 20 ml vial (1000 micrograms) Pack sizes: 2, 10 and 50 (5 x 10)
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
biosyn Arzneimittel GmbH
Schorndorfer Strasse 32
70734 Fellbach
Germany
This medicinal product is authorized under the European Economic Area under the names:
Denmark: Selesyn 100 micrograms, solution for injection or infusion
Denmark: Selesyn 50 micrograms/ml, solution for injection or infusion
Sweden: Selesyn 100 micrograms, solution for injection or infusion
Sweden: Selesyn 50 micrograms / ml, solution for injection / infusion
Germany: selenase® 100 micrograms solution for injection / solution for infusion
Germany: selenase® 50 micrograms / ml solution for injection / infusion solution
France: SELENIUM PANPHARMA 100 micrograms, injectable solution