NUTRYELT concentrate for solution for infusion

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

The name of this medicinal product is NUTRYELT^®, concentrate for solution for infusion, but will be referred as NUTRYELT^® throughout the whole leaflet.

1. What NUTRYELT^® is and what it is used for
2. What you need to know before you use NUTRYELT^®
3. How to use NUTRYELT^®
4. Possible side effects
5. How to store NUTRYELT^®
6. Contents of the pack and other information

• if you are allergic (hypersensitive) to any of the ingredients of NUTRYELT^® (see section 6 of this leaflet).
• if you have abnormally high level of any of the ingredients of the product in your blood. (If you have any doubt, ask your doctor).
• if you have a pronounced cholestasis (yellowing of the skin or whites of the eyes caused by liver or blood problem).
• if you have an excess of copper (Wilson's disease) or iron in the body (hemochromatosis).

Talk to your doctor or pharmacist before using NUTRYELT^® if:

• you have kidney problems,
• you have liver problems such as mild cholestasis (impaired liver function with a yellowing of the skin or whites of eyes),
• you receive repeated blood transfusions,
• you have diabetes and are on insulin medication,
• you have thyroid problems, or if you are taking iodine-containing medicines (e.g. iodine antiseptics).

Blood levels of trace elements will be monitored regularly by your doctor during the treatment, and your doctor will adapt the dosage of NUTRYELT^® accordingly.

NUTRYELT^® must not be used in children and adolescents.

Tell your doctor if you are taking, have recently taken or might take any other medicines. Particularly iron salts (oral route).

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

NUTRYELT^® should not be used during pregnancy and lactation unless the doctor considers it absolutely necessary.

This medicinal product contains less than 1 mmol sodium (23 mg) per ampoule, i.e. essentially "sodium-free".

This medicinal product contains less than 1 mmol potassium (39 mg) per ampoule, i.e. essentially "potassium-free".

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

NUTRYELT^® is not intended to be administered in its current presentation.

NUTRYELT^® must be diluted or mixed with gentle agitation during preparation under strict aseptic conditions, before infusion.

NUTRYELT^® must be diluted with respect to the final appropriate osmolarity.

For example:

• 10 to 20 ml of NUTRYELT^® can be diluted in at least 250 ml of Sodium Chloride 0.9% solution for infusion,
• 10 to 20 ml of NUTRYELT can be diluted in at least 250 ml of Glucose 5% solution for infusion.

The pH after reconstitution of 20 ml of NUTRYELT^® with 250 ml Sodium chloride 0.9% will be 3.3, or 3.3-3.4 with Glucose 5%. The reconstituted solution for infusion has to be visually inspected prior to use.

Only clear solution without particles should be used.

Do not store partly used containers and discard all equipment after use.

The compatibility with solutions administered simultaneously via a common inlet cannula must be ensured.

Degradation of ascorbic acid in parenteral nutrition mix is accelerated by trace elements.

This medicinal product must not be mixed with other medicinal products except those mentioned in this section.

NUTRYELT^® must not be used as a vehicle for other drugs.

Your doctor will determine the right dosage for you.

The recommended daily dose is one ampoule (10 ml) of NUTRYELT^®. Your doctor can give you up to 2 ampoules per day.

NUTRYELT^® must not be used in children and adolescents.

A product specific for children and adolescents should be used to provide them with trace elements when they need intravenous (into a vein) feeding.

Your doctor will stop your treatment with NUTRYELT^® and do the necessary laboratory tests in the case of suspected overdose.

The active substances are:

For 10 ml NUTRYELT^®

Zinc (Zn) 10000 µg (as Zinc gluconate)

Copper (Cu) 300 µg (as Copper gluconate)

Manganese (Mn) 55 µg (as Manganese gluconate)

Fluorine (F) 950 µg (as Sodium fluoride)

Iodine (I) 130 µg (as Potassium iodide)

Selenium (Se) 70 μg (as Sodium selenite)

Molybdenum (Mo) 20 µg (as Sodium molybdate)

Chromium (Cr) 10 µg (as Chromium chloride)

Iron (Fe) 1000 µg (as Ferrous gluconate)

pH: 2.6 to 3.2

Osmolarity: 60 to 100 mosm/L

The other ingredients are hydrochloric acid and water for injections.

NUTRYELT^® is a clear, limpid and slightly yellow concentrate for solution for infusion in a 10 ml ampoule.

NUTRYELT^® is packed in boxes of 4, 10, 25 and 50 ampoules.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Manufacturer

This medicinal product is authorised in the Member States of the EEA under the following names:

Austria NUTRYELT^®, Konzentrat zur Herstellung einer Infusionslosung

Belgium NUTRYELT^®, solution à diluer pour perfusion / Konzentrat zur Herstellung einer Infusionslosung / Concentraat voor oplossing voor infusie

Czech Republic NUTRYELT^®, Koncentrát pro infuzní roztok

Denmark Nutryelt

Finland NUTRYELT^®, infuusiokonsentraatti, liuosta varten

France NUTRYELT^®, solution à diluer pour perfusion

Germany ADDEL TRACE^®, Konzentrat zur Herstellung einer Infusionslosung

Italy SUPPLYELT^®

Luxembourg NUTRYELT^®, solution à diluer pour perfusion

Netherlands NUTRYELT^®, concentraat voor oplossing voor infusie

Norway NUTRYELT^®, Konsentrat til infusjonsvæske, oppløsning

Poland NUTRYELT^®

Portugal NUTRYELT^®

Sweden Nutryelt^®, koncentrat till infusionsvätska, lösning

United-Kingdom NUTRYELT^®, concentrate for solution for infusion