Skip to Content

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 / CHROMIUM CHLORIDE HEXAHYDRATE / COPPER GLUCONATE / FERROUS GLUCONATE / MA

View full screen / Print PDF » Download PDF ⇩

PDF Transcript

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. A
• 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 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,

• y ou have thyroid problems, or if you are taking iodinecontaining 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 and adolescents.
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).
Pregnancy and Breast-feeding
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.
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.

TECHNICAL LEAFLET

NUTRYELT, concentrate for solution for infusion

The following information is intended for medicinal and healthcare professional only.

List of excipients: Hydrochloric acid, water for Injections
Description of solution: Clear, limpid and slightly yellow solution.
Posology and method of administration: For adults only.
The recommended daily dose in patients with basal to moderately increased requirements is one ampoule (10 ml)
of NUTRYELT.
In cases of significantly increased trace element requirements (such as extensive burns, patients in severe hypercatabolic state
due to major trauma) 2 ampoules (20 ml) of NUTRYELT may be given per day, and monitoring of serum trace element level is
recommended.
In patients with renal, hepatic impairments or mild cholestasis the posology should be adapted.
Paediatric population: NUTRYELT is contraindicated in children and adolescents.
A specific paediatric product should be used for trace element supplementation in the paediatric population during parenteral
nutrition.
Method of administration
NUTRYELT is not intended to be administered in its current presentation. It should be diluted according to the final desired
osmolarity. The osmolarity value of the final preparation allows either administration through a peripheral vein, or only
central venous catheter administration.

xxxxxx MM/17

Qualitative and Quantitative composition
Composition for 1000 ml NUTRYELT
Content per ampoule of 10 ml
Zinc gluconate
Zinc (Zn)
6970.0 mg
10000 µg
Copper gluconate
214.24 mg
Copper (Cu)
300 µg
Manganese gluconate
44.569 mg
Manganese (Mn)
55 µg
Sodium fluoride
209.95 mg
Fluorine (F)
950 µg
Potassium iodide
Iodine (I)
17.006 mg
130 µg
Sodium selenite
15.332 mg
Selenium (Se)
70 µg
Sodium molybdate
Molybdenum (Mo)
4.293 mg
20 µg
3.045 mg
10 µg
Chromium chloride
Chromium (Cr)
Ferrous gluconate
Iron (Fe)
798. 82 mg
1000 µg
Density: 1.0
pH: 2.6 to 3.2
Osmolality: 60 to 100 mosm/kg
Osmolarity: 60 to 100 mosm/l

Use in children
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.
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.

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:
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard or search for MHRA
Yellow Card in the Google Play or Apple App Store.
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)
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.

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 Authorisation Holder
Laboratoire AGUETTANT
1 rue Alexander Fleming
69007 LYON
France
Manufacturer
Laboratoire AGUETTANT
Lieu-dit « Chantecaille »
07340 CHAMPAGNE-SERRIERES
France
Distributed by
Baxter Healthcare Limited
Caxton Way, Thetford, Norfolk, IP24 3SE
United Kingdom
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
Nutryelt
Denmark
Finland NUTRYELT, infuusiokonsentraatti, liuosta
varten
France NUTRYELT, solution à diluer pour perfusion
Germany ADDEL TRACE, Konzentrat zur Herstellung
einer Infusionslosung
Greece NUTRYELT, πυκνό διάλυμα για παρασκευή
διαλύματος προς έγχυση
Ireland SUPPLYELT, concentrate for solution for
infusion
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
Spain NUTRYELT, concentrado para solución para
perfusión
Sweden Nutryelt, koncentrat till infusionsvätska,
lösning
United-Kingdom NUTRYELT, concentrate for solution for
infusion
This leaflet was last revised in 06/2017.

Pharmaceutical Particulars
Incompatibilities
• NUTRYELT must not be used as a vehicle for other drugs.
• NUTRYELT, as with other trace element solutions, cannot be added directly to inorganic phosphate (additive) solutions.
• 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 sodium chloride 0.9% and glucose 5%.
Shelf life
3 years.
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.
Special precaution for storage
Do not freeze.
Keep the container in the outer carton in order to protect from light.
Nature and content of container
10 ml solution in polypropylene ampoule in pack sizes of 10, 25 and 50.
Instructions for use and handling and disposal
Before use, check that the concentrate for solution for infusion is homogeneous and that the bottle is not damaged and is free of
particles.
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.

Expand Transcript

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.

Hide