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NUTRYELT CONCENTRATE FOR SOLUTION FOR INFUSION

Active substance(s): CHROMIUM CHLORIDE HEXAHYDRATE / COPPER GLUCONATE / FERROUS GLUCONATE / MANGANESE GLUCONATE / POTASSIUM IODIDE / SODIUM FLUORIDE / SODIUM MOLYBDATE DIHYDRATE / SODIUM SELENITE / ZINC GLUCONATE

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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 µg

(as Zinc gluconate)

Copper (Cu)

300 µg

(as Copper gluconate)

Manganese (Mn)

55 µg

(as Manganese gluconate)

Fluorine (F)

950µg

(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.
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]

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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