Package leaflet: Information for the user

NUTRYELT
Concentrate for solution for infusion
Please read all of this leaflet carefully before using this medicine, because it contains
important information for the patient.

Keep this leaflet, as you may need to read it again.
If you have any further questions, please consult your doctor, pharmacist, or nurse.
This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, even if their symptoms are the same.
If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, please inform your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet

What NUTRYELT is and what it is used for
What you need to know before using NUTRYELT
How to use NUTRYELT
Possible side effects
How to store NUTRYELT
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, and molybdenum).
These trace elements are considered essential because the body cannot produce them on its own,
but they are required in very small amounts for normal body function.
NUTRYELT is used to provide trace elements in adult patients requiring parenteral nutrition.

2. Important information before using NUTRYELT.

When not to use NUTRYELT:

if the patient is allergic (hypersensitive) to any of the ingredients of NUTRYELT (see section 6 of this leaflet);
if the patient has abnormally high blood levels of any component contained in this medicine (in case of any doubts, consult a doctor);
if the patient has pronounced cholestasis (yellowing of the skin or whites of the eyes caused by liver or blood disorders);
if the patient has excess copper (Wilson's disease) or iron (hemochromatosis) in the body.

Warnings and precautions
Before using NUTRYELT, discuss with a doctor or pharmacist:

if the patient has impaired kidney function;
if the patient has impaired liver function, such as mild cholestasis (liver dysfunction with yellowing of the skin or whites of the eyes);
if the patient receives repeated blood transfusions;
if the patient has diabetes and is treated with insulin;
if the patient has thyroid disease or is using iodine-containing medicines (e.g. iodine antiseptic preparations).

During treatment, the doctor will regularly monitor trace element levels in the blood.
The doctor will adjust the dosage of NUTRYELT accordingly.
Children
NUTRYELT should not be used in children and adolescents.
Interaction of NUTRYELT with other medicines
Inform the doctor about all medicines currently taken or recently used, as well as any medicines the patient intends to take. In particular, inform the doctor about concomitant use of iron salts (administered orally).
NUTRYELT and alcohol
Not applicable.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she might be pregnant, or plans to become pregnant, she should consult a doctor or nurse before using this medicine.
NUTRYELT should not be used during pregnancy and lactation unless the doctor considers it absolutely necessary.
Driving and operating machinery
Not applicable.
NUTRYELT contains sodium and potassium
The medicine contains less than 1 mmol (23 mg) of sodium per ampoule, meaning the medicine is considered "sodium-free".
The medicine contains less than 1 mmol (39 mg) of potassium per ampoule, meaning the medicine is considered "potassium-free".
If there are any further doubts regarding the use of this medicine, consult a doctor or pharmacist.

3. How to use the medicine NUTRYELT

The medicine NUTRYELT is intended for use only in adult patients.
NUTRYELT will be administered intravenously (into a vein) by a doctor or nurse.
This medicine should always be used as directed by the doctor. If in doubt, consult
your doctor or pharmacist.

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

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

The pH of the reconstituted solution of 20 ml NUTRYELT product using 250 ml of 0.9% sodium chloride is 3.3, and when using 5% glucose, the pH is 3.3–3.4.
Before use, visually inspect the reconstituted infusion solution. Only a clear solution, free from solid particles, should be used.
Do not store partially emptied containers and dispose of all equipment after use.
Check compatibility with solutions administered simultaneously through the same cannula.
Trace elements accelerate the degradation of ascorbic acid in parenteral nutrition mixtures.
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
The doctor will determine the dose appropriate for the patient.
The recommended daily dose is one ampoule (10 ml) of NUTRYELT. The doctor may administer up to 2 ampoules per day to the patient.

Use in children
NUTRYELT should not be used in children and adolescents.
If parenteral nutrition is required for supplementation of trace elements in children and adolescents, a specific product intended for this patient group should be used.

Use of a higher than recommended dose of NUTRYELT
In case of suspected overdose, the doctor will discontinue treatment with NUTRYELT
and perform necessary laboratory tests.

Discontinuation of NUTRYELT
Not applicable.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Tell your doctor if any of the following adverse reactions occur:
Frequency unknown (frequency cannot be determined from available data): Pain at the injection site.
In patients receiving intravenous solutions containing iron, cases of hypersensitivity reactions have been reported, including anaphylactic reactions resulting in death.
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions allows further information on the safety of this medicine to be collected.

5. How to store NUTRYELT

It has been demonstrated that after dilution, the product maintains physical and chemical stability for 48 hours at 25°C, protected from light.
From a microbiological standpoint, the product should be used immediately after dilution. If the product is not used immediately, the responsibility for the storage period and conditions prior to use lies with the user.
Keep the medicine out of the 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 stated month.
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 undamaged, and the solution contains no solid particles.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What NUTRYELT contains
The active substances 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)
Fluoride (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) 1,000 µg (as iron gluconate)
pH: 2.6 to 3.2
Osmolarity: 60 to 100 mOsm/L

The other components are hydrochloric acid and water for injections.

What NUTRYELT looks like and contents of the pack
NUTRYELT is a clear, transparent, slightly yellowish concentrate for solution for infusion, in a 10 ml ampoule.
NUTRYELT is packed in cartons containing 4, 10, 25, and 50 ampoules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Marketing Authorisation Holder
LABORATOIRE AGUETTANT
1 rue Alexander Fleming
69007 Lyon
France

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

This medicinal product is authorised in the European Economic Area (EEA) under the following names:
Austria NUTRYELT, Konzentrat zur Herstellung einer Infusionslösung
Belgium NUTRYELT, solution à diluer pour perfusion / Konzentrat zur Herstellung einer Infusionslösung / 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 Infusionslösung
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