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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.
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).
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
This medicinal product contains less than 1 mmol sodium
(1.2 mg) per ampoule, i.e. essentially “sodium-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 a doctor. Always use this medicine
exactly as your doctor has told you. Check with your
doctor or pharmacist if you are not sure.
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.
NUTRYELT will be diluted before use.
Use in children
NUTRYELT must not be used in children.

TECHNICAL LEAFLET

NUTRYELT, concentrate for solution for infusion

The following information is intended for medicinal and healthcare professional only.
Qualitative and Quantitative composition
Composition for 1000 ml NUTRYELT
Content per ampoule of 10 ml
Zinc gluconate
6970.0 mg
Zinc (Zn)
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
17.006 mg
Iodine (I)
130 μg
Sodium selenite
15.332 mg
Selenium (Se)
70 μg
Sodium molybdate
4.293 mg
Molybdenum (Mo)
20 μg
Chromium chloride
3.045 mg
Chromium (Cr)
10 μg
Ferrous gluconate
798. 82 mg
Iron (Fe)
1000 μg
Density: 1.0
pH: 2.6 to 3.2
Osmolality: 60 to 100 mosm/kg
Osmolarity: 60 to 100 mosm/l
List of excipients: Hydrochloric acid, water for Injections
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.
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.

102704 08/15

Description of solution: Clear, limpid and slightly yellow solution.

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
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.
Do not use this medicine if you notice visible signs of
deterioration.
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)................ 1000 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)
The other ingredients are hydrochloric acid and water
for injections.
What NUTRYELT looks like and contents of the pack
NUTRYELT is a clear, uncloudy 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-SERRIÈRES - 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:
NUTRYELT, Concentrate for solution for infusion
NUTRYELT, Solution à diluer pour perfusion
NUTRYELT, Konzentrat zur Herstellung einer
Infusionslösung
NUTRYELT
This leaflet was last revised in 08/2015.

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:
2 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 ml of NUTRYELT can be diluted in at least 250 ml of Sodium Chloride 0.9% solution for infusion,
• 10 ml of NUTRYELT can be diluted in at least 250 ml of Glucose 5% solution for infusion.
NUTRYELT should only be mixed with other IV solutions when compatibility with these solutions has been proven in
advance.
Compatibility data and shelf-life for other mixtures may be provided on request by the manufacturer.
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.

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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.

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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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