Selenase 100 micrograms NL/H/0425/002-004/IA/019

biosyn Arzneimittel GmbH

Schorndorfer Strasse 32, 70734 Fellbach, Germany

PACKAGE LEAFLET: INFORMATION FOR THE USER

Selenase® 100 micrograms, solution for injection (50 micrograms/ml)

100 microgram selenium per 2 ml solution for injection

Selenase® 500 micrograms, solution for injection (50 micrograms/ml)

500 microgram selenium per 10 ml solution for injection

Active substance: Sodium selenite pentahydrate

Read all of this leaflet carefully before you start using this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you. Do not pass it on to others. It may harm
them, even if their symptoms are the same as yours.
- If any of the side effects gets serious, or if you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.

In this leaflet:
1. What Selenase® solution for injection is and what it is used for
2. Before you use Selenase® solution for injection
3. How to use Selenase® solution for injection
4. Possible side effects
5. How to store Selenase® solution for injection
6. Further information

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 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 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).

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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
• 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 thingling).

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
<to be completed nationally>.
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.

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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 glass with
a rubber stopper.
Pack sizes: 2 and 10.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and 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 500 micrograms, solution for injection (50 micrograms/ml)

This leaflet was last approved in 07/2015.

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

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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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