Nutrielt

Package Leaflet: Information for the User

NUTRYELT

Concentrate for solution for infusion

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• Ask your doctor, pharmacist, or nurse if you have any further questions.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet

• 1. What is NUTRYELT and what is it used for
• 2. Important information before using 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 is NUTRYELT and what is it used for

NUTRYELT is a concentrate for solution for infusion.
It contains 9 essential trace elements (iron, copper, manganese, zinc, fluorine, iodine, selenium, chromium, and molybdenum).
These trace elements are considered essential because the body cannot produce them on its own,
but they are needed in very small amounts for its proper functioning.
NUTRYELT is used to provide trace elements to adult patients who require intravenous nutrition.

2. Important information before using NUTRYELT.

When not to use NUTRYELT:

• if you are allergic (hypersensitive) to any of the ingredients of NUTRYELT (see section 6 of this leaflet);
• if you have an abnormally high level of any of the ingredients of NUTRYELT in your blood (if in doubt, consult your doctor);
• if you have severe cholestasis (yellowing of the skin or whites of the eyes due to liver or blood disorders);
• if you have an excess of copper (Wilson's disease) or iron (hemochromatosis) in your body.

Warnings and precautions

Before using NUTRYELT, discuss it with your doctor or pharmacist:

• if you have kidney problems;
• if you have liver problems, such as mild cholestasis (liver problems with yellowing of the skin or whites of the eyes);
• if you receive multiple blood transfusions;
• if you have diabetes and are being treated with insulin;
• if you have a thyroid problem or are taking iodine-containing medications (e.g., iodine-based antiseptics).

During treatment, your doctor will regularly check the levels of trace elements in your blood.
Your doctor will adjust the dosage of NUTRYELT accordingly.

Children

NUTRYELT is not used in children and adolescents.

NUTRYELT and other medicines

Tell your doctor about all the medicines you are taking, or have recently taken, and any medicines you plan to take.
Especially, tell your doctor if you are taking iron salts (given orally).

NUTRYELT with alcohol

Not applicable.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor or nurse for advice before using this medicine.
NUTRYELT should not be used during pregnancy and lactation, unless your doctor considers it absolutely necessary.

Driving and using machines

Not applicable.

NUTRYELT contains sodium and potassium

The medicine contains less than 1 mmol (23 mg) of sodium per ampoule, which means it is considered "sodium-free".
The medicine contains less than 1 mmol (39 mg) of potassium per ampoule, which means it is considered "potassium-free".
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

3. How to use NUTRYELT

NUTRYELT is intended for use in adult patients only.
NUTRYELT will be administered to you intravenously (into a vein) by your doctor or nurse.
This medicine should always be used according to your doctor's instructions. If you are unsure, ask your doctor or pharmacist.

Instructions for dilution before administration of NUTRYELT

NUTRYELT is not intended for administration in its undiluted form. NUTRYELT should be diluted or added to other solutions by gently mixing, under strict aseptic conditions, immediately before administration.
NUTRYELT should be diluted, taking into account the final osmolality of the solution, for example:

• 10 to 20 ml of NUTRYELT can be diluted by adding at least 250 ml of 0.9% sodium chloride solution for infusion;
• 10 to 20 ml of NUTRYELT can be diluted by adding at least 250 ml of 5% glucose solution for infusion.

The pH of the reconstituted solution of 20 ml of NUTRYELT using 250 ml of sodium chloride 0.9% is 3.3, and using glucose 5% is 3.3-3.4.
Before use, inspect the reconstituted infusion solution. Only use a clear solution without solid particles.
Do not store partially used containers and dispose of all equipment after use.
Check compatibility with solutions administered simultaneously through a common cannula.
Trace elements accelerate the degradation of ascorbic acid in mixtures for parenteral nutrition.
Do not mix the medicinal product with other medicinal products, except those mentioned in this section.
Do not use NUTRYELT as a vehicle for other medicines.

Recommended dose

Your doctor will determine the dose suitable for you.
The recommended daily dose is one ampoule (10 ml) of NUTRYELT. Your doctor may administer up to 2 ampoules per day.

Use in children

NUTRYELT is not used in children and adolescents.
If necessary, for parenteral nutrition to supplement trace elements in children and adolescents, a specific product intended for this patient group should be used.

Use of a higher dose of NUTRYELT than recommended

In case of suspected overdose, your doctor will discontinue treatment with NUTRYELT and perform necessary laboratory tests.

Discontinuation of 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 experience any of the following side effects:
Frequency not known (frequency cannot be estimated from the available data): Pain at the injection site.
In patients receiving intravenous solutions containing iron, cases of hypersensitivity reactions, including anaphylactic reactions resulting in death, have been reported.
If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: + 48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store NUTRYELT

It has been shown that after dilution, the product remains physically and chemically stable for 48 hours at 25°C, protected from light.
From a microbiological point of view, the product should be used immediately after dilution. If the product is not used immediately, the user is responsible for the storage conditions prior to use.
Store the medicine in a place out of sight and reach of children.
Do not use this medicine after the expiry date stated on the label (EXP). The expiry date refers to the last day of the month stated.
Do not freeze.
Store in the original packaging to protect from light.
Before use, ensure that the concentrate for solution for infusion is homogeneous, the ampoule is not damaged, and the solution does not contain solid particles.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What NUTRYELT contains

The active substances of NUTRYELT are:
For NUTRYELT 10 ml:
Zinc (Zn)
10,000 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 iron gluconate)
pH: 2.6 to 3.2
Osmolality: 60 to 100 mOsm/L
Other ingredients are hydrochloric acid and water for injections.

What NUTRYELT looks like and contents of the pack

NUTRYELT is a clear, transparent, and slightly yellowish concentrate for solution for infusion in a 10 ml ampoule.
NUTRYELT is packaged in boxes containing 4, 10, 25, and 50 ampoules.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

LABORATOIRE AGUETTANT
1 rue Alexander Fleming
69007 Lyon
France

Manufacturer

Laboratoire AGUETTANT
route n 86 – champagne sur rhône
07340 SERRIERES
France

This medicine has been authorized in the Member States of the European Economic Area 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

Luxembourg

NUTRYELT, solution à diluer pour perfusion

Germany

ADDEL TRACE, Konzentrat zur Herstellung einer Infusionslosung

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

Italy

SUPPLYELT

Date of last revision of the leaflet: MM/RRRR.