Overdose:

Symptoms of acute overdose are: garlicky breath, tiredness, nausea and vomiting, diarrhoea and abdominal pain. In case of chronic overdose, effects on skin and phaneres with changes in the nail and hair growth as well as peripheral polyneuropathies have been observed.

In case of overdose, the treatment must be interrupted, and a symptomatic treatment should be given if necessary. In case of acute overdose, gastric lavage and forced diuresis are possible. There is no known specific antidote.

Incompatibilities:

Selenium is generally incompatible with high concentration of ascorbic acid (reduction of selenite to elemental selenium which is not soluble and unavailable as a nutritional source of selenium).

SELENIUM 10 micrograms/ml, solution for infusion can not be mixed with medicines other than sodium chloride 0.9%, glucose 5%, solution for parenteral nutrition or solution of trace elements.

Storage and shelf-life:

After opening/reconstitution/dilution, the product must be use immediately.

There are no special storage conditions.

Package leaflet: Information for the patient

SELENIUM 10 micrograms/ml Solution for infusion

Sodium selenite

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

•    Keep this leaflet. You may need to read it again.

•    If you have any further questions, ask your doctor or pharmacist.

•    If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

The name of this medicinal product is SELENIUM 10 micrograms/ml Solution for infusion, but will be referred as SELENIUM throughout the whole leaflet.

What is in this leaflet:

1.    What SELENIUM is and what it is used for

2.    What you need to know before you use SELENIUM

3.    How to use SELENIUM

4.    Possible side effects

5.    How to store SELENIUM

6.    Contents of the pack and other information

1.    What SELENIUM is and what it is used for

SELENIUM contains the active substance sodium selenite. It belongs to a group of mineral supplements and provides a nutritional source of selenium. Selenium is an essential trace element that ensures your metabolism functions efficiently.

SELENIUM is used to:

•    Prevent selenium deficiency in patients receiving parenteral nutrition (artificial feeding through a vein).

•    Treat selenium deficiency that cannot be cured by intake from food alone.

SELENIUM can be used in adults and in children.

Selenium is a trace element. It means your body needs only very small quantity of this nutriment. Selenium is essential for some of your organs (thyroid gland, liver, muscles), and your defence against risk of infection (immune system). Selenium also enhances the protection of your cell membranes against potential attack from diseases. Any selenium deficiency in your body might induce weakness of these organs or systems which could lead to tiredness, shortness of breath, muscular discomfort, abnormalities in nails or hair.

2.    What you need to know before you use SELENIUM

Do not use SELENIUM:

•    if you are allergic to selenium compounds.

•    if you have selenosis (selenium poisoning).

Warnings and precautions

This medicine should not be injected without prior dilution.

Your doctor will use SELENIUM with caution if you are being administered nutrition through a vein (parenteral nutrition) and need to be given other medicines at the same time. This will help avoid undesirable reactions. SELENIUM should not be administered at the same time as ascorbic acid (vitamin C). When these two substances are mixed, selenium can no longer be used by the body as a nutrition source.

Other medicines and SELENIUM

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Pregnancy: The use of SELENIUM may be considered during pregnancy, if necessary.

Breast-feeding: Selenium is excreted in human milk. Doses correcting selenium deficiency in breast-feeding women are not expected to exert adverse effects on the breastfed infants.

Fertility: Doses correcting selenium deficiency are not expected to impact fertility.

3.    How to use SELENIUM

This medicine will always be administered to you by a healthcare professional.

Your doctor will determine the dose of SELENIUM based on your needs. Samples of your blood will be taken during treatment.

Your doctor will monitor the level of selenium in your blood to ensure it does not exceed the recommended level. The recommended dose is:

Adults

•    To supplement total parenteral nutrition: 60 to 100 micrograms daily.

•    Other situations with proven selenium deficiency: 100 micrograms up to a maximum of 400 micrograms daily. Treatment will be given until your selenium levels are normal.

Use in children

•    Infants: 2 micrograms/kg/day and infants with low birth weight: 2 to 3 micrograms/kg/day.

•    Children: 2 micrograms/kg/day, up to a maximum of 30 micrograms daily.

Method of administration

SELENIUM will be diluted before it is given to you as a slow infusion.

Duration of administration

The treatment duration will be determined by your doctor.

If you use more SELENIUM than you should:

Symptoms of acute (short-term) overdose are garlicky breath, tiredness, vomiting, diarrhoea and abdominal pain.

In case of chronic (long-term) overdose, skin and hair and nails can be affected with changes in nail and hair growth and may lead to peripheral polyneuropathies (a nerve disorder that can result in numbness or tingling).

In case of overdose, treatment includes stomach pumping (gastric lavage) and forced diuresis. In case of extreme overdose (1,000 - 10,000x), elimination of selenite by dialysis can be tried. There is no specific antidote.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4.    Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

There are no known side-effects in case of proper use.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

You can also report side effects directly via the Yellow Card Scheme at: 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 SELENIUM

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and vial label. The expiry date refers to the last day of that month.

There are no specific storage conditions for this medicine.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6.    Contents of the pack and other information

What SELENIUM contains:

•    The active substance is sodium selenite. One 10 ml vial contains 219 micrograms sodium selenite, equivalent to 100 micrograms of selenium.

•    The other ingredient is water for injection.

What SELENIUM looks like and contents of the pack:

SELENIUM is a clear, colourless solution for infusion in glass vial. Pack of 10 vials.

Marketing Authorisation Holder Manufacturer:

Laboratoire AGUETTANT    Laboratoire AGUETTANT    DELPHARM Tours

1, Rue Alexander Fleming    1, Rue Alexander Fleming    Rue Paul Langevin

69007 LYON    69007 LYON    37170 CHAMBRAY LES TOURS

France    France    France

Distributed by: AGUETTANT LTD - Unit 1, Farleigh House - Flax Bourton - BRISTOL, BS48 1UR - England This leaflet was last revised in 06/2014.

Technical leaflet

The following information is intended for healthcare professionals only:

This is an extract from the Summary of Product Characteristics to assist in the administration of Selenium Infusion. When determining appropriateness of use in a particular patient, the prescriber should be familiar with the Summary of Product Characteristics of the product.

Drug name:

SELENIUM 10 micrograms/ml Solution for infusion

Method of administration and Posology:

Intravenous administration:

SELENIUM 10 micrograms/ml solution for infusion must be administered with low infusion rate after dilution in solution for parenteral nutrition, after stability has been validated, or in isotonic solution (such as sodium chloride 0.9% or glucose 5%).

The dose must be adapted individually according to selenium deficiency and selenium status. For monitoring of therapy the selenium concentration in whole blood or serum should be determined. The whole blood level of selenium should be between 120 and 160 micrograms/l, the concentration of selenium in serum should not exceed 130 micrograms/l.

The recommended posology is:

•    Adults:

ⁿ Supplementation to total parenteral nutrition: 60 to 100 micrograms daily. ⁿ Other situation with proven selenium deficiency: 100 micrograms up to a maximum of 400 micrograms daily for a short-term until normalization of laboratory monitoring values

•    Paediatric population:

^D Infants: 2 micrograms/kg/day and infants with low birth weight: 2 to 3 micrograms/ kg/day.

ⁿ Children: 2 micrograms/kg/day, up to a maximum of 30 micrograms daily.

Special warnings:

The product must not be injected straight, but diluted in a solution for infusion.

Precautions for use:

Serum selenium levels must be controlled regularly.

In case of complex parenteral nutrition and if mixing of medicines is necessary, caution is required in order to avoid incompatibilities.