Skip to Content

SELENASE 500 MICROGRAMS SOLUTION FOR INJECTION (50 MICROGRAMS/ML)

Active substance(s): SODIUM SELENITE PENTAHYDRATE

View full screen / Print PDF » Download PDF ⇩
Transcript
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.
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
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.
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.
If any side effects occur or if you notice any side effects not listed in
this leaflet, please tell your doctor or pharmacist.
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 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
Distributed by:
Baxter Healthcare Limited
Caxton Way, Thetford, Norfolk, IP24 3SE, United Kingdom
This medicinal product is authorised in the Member States of the
EEA under the following names:
NL: selenase® oplossing voor injectie 100 µg
selenase® oplossing voor injectie 500 µg
CZ: selenase® injekční roztok 500 µg, injekční roztok 50 µg/ml
HU: selesyn® 100 µg/2 ml, oldatos injekció
selesyn® 500 µg/10 ml, 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)

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)
IT:

This leaflet was last approved in 01/2013.
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.
Druck-Nr. W 07-6335 / Code 335

(Tx-21410) - Datum: January 2013

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide