Package leaflet: Information for the user NUTRYELT, Concentrate for solution for infusion

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, 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

What is in this 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

1. What NUTRYELT is and what it is used for

NUTRYELT is a concentrate for solution for infusion.

It contains 9 essential trace elements (iron, copper, manganese, zinc, fluorine, iodine, selenium, chromium, molybdenum).

These trace elements are considered as essential because the body cannot produce them but needs them in very small quantities in order to function properly.

NUTRYELT is used to provide trace elements in adults needing intravenous (into a vein) feeding.

2. What you need to know before you use NUTRYELT

Do not use NUTRYELT:

-    if you are allergic (hypersensitive) to any of the ingredients of NUTRYELT (See section 6 of this leaflet).

-    if your body weight is less than 40 kg.

-    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).

Warnings and precautions

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.

Children

NUTRYELT must not be used in children Other medicines and NUTRYELT

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

NUTRYELT and alcohol

Not applicable

Pregnancy and Breastfeeding

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.

Driving and using machines

Not applicable

NUTRYELT contains sodium and potassium

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.

3. How to use NUTRYELT NUTRYELT is intended for adult patients only.

NUTRYELT will be given to you intravenously (into a vein) by a nurse or doctor. Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Instructions for dilution of NUTRYELT before administration:

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.

Dosage

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.

Use in children

NUTRYELT must not be used in children If you take more NUTRYELT than you should

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

If you stop taking NUTRYELT

Not applicable

4.    Possible side effects

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

Tell your doctor if you notice any of the following:

Frequency not known (cannot be estimated from the available data): Pain at the application site.

Cases of hypersensitivity reactions including fatal anaphylactic reactions have been reported in patients receiving IV iron-containing products.

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 the national reporting system listed in Appendix V*. By reporting side effects you can help provide more information on the safety of this medicine.

5.    How to store NUTRYELT

After dilution, chemical and physical in-use stability has been demonstrated for 48 h at 25°C, protected from light.

From a microbiological point of view, the product should be used immediately after dilution. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.

Keep this medicine out the sight and reach of children.

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

Do not freeze.

Keep the container in the outer carton in order to protect from light.

Before use, check that the concentrate for solution for infusion is homogeneous and that the bottle is not damaged and is free of particles.

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 NUTRYELT contains

The active substances are:

For 10 ml NUTRYELT

Zinc (Zn)	10000 pg	(as Zinc gluconate)
Copper (Cu)	300 pg	(as Copper gluconate)
Manganese (Mn)	55 Pg	(as Manganese gluconate)
Fluorine (F)	950pg	(as Sodium fluoride)
Iodine (I)	130 pg	(as Potassium iodide)
Selenium (Se)	70 Pg	(as Sodium selenite)
Molybdenum (Mo)	20 pg	(as Sodium molybdate)
Chromium (Cr)	10 Pg	(as Chromium chloride)
Iron (Fe)	1000 pg	(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.

What NUTRYELT looks like and contents of the pack

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

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

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing authorization holder

Laboratoire Aguettant 1 rue Alexander Fleming 69007 LYON France

Manufacturer

Laboratoire AGUETTANT Lieu-dit « Chantecaille »

07340 CHAMPAGNE-SERRIERES France

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

This leaflet was last revised in

[To be completed nationally]