Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
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.
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,
• 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 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.
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 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.
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.
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.
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 4, 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
Denmark Nutryelt
Finland NUTRYELT ® , infuusiokonsentraatti, liuosta varten
France NUTRYELT ® , solution à diluer pour perfusion
Germany ADDEL TRACE ® , Konzentrat zur Herstellung einer Infusionslosung
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 ®
Sweden Nutryelt ® , koncentrat till infusionsvätska, lösning
United-Kingdom NUTRYELT ® , concentrate for solution for infusion
This leaflet was last revised in 08/2019.
Baxter Healthcare Ltd
Address
Caxton Way, Thetford, Norfolk, IP24 3SE, UK
WWW
https://www.baxterhealthcare.co.uk/
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https://medinfo.baxterhealthcare.co.uk
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0800 028 9881
E-mail
[email protected]
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[email protected]
Adverse event reporting telephone
+44 (0)800 026 0920
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NUTRYELT concentrate for solution for infusion comes as solution. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in NUTRYELT concentrate for solution for infusion is chromium chloride.
This leaflet reproduces the patient information leaflet approved for NUTRYELT concentrate for solution for infusion, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
NUTRYELT is used as part of an intravenous nutrition regimen, to cover basal or moderately increased trace element requirements in parenteral nutrition.
NUTRYELT is indicated in adults only.
Posology
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 (see section 4.4).
Paediatric population
NUTRYELT is contraindicated in children and adolescents (see section 4.3).
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.
For incompatibilities and instructions for use see 6.2 and 6.6.
- Children and adolescents
- Pronounced cholestasis (serum bilirubin > 140 µmol/l)
- hypersensitivity to the active substances or to any of the excipients listed in section 6.1
- in cases of Wilson's disease and hemochromatosis
- if serum concentrations of any of the trace elements contained in NUTRYELT are elevated.
Combinations not recommended:
+ Iron salts (oral route):
Fainting or shock attributed to the rapid release of iron from its complex shape and transferrin saturation.
Pregnancy
No safety data for NUTRYELT are available when it is administered during pregnancy.
Therefore, NUTRYELT should not be used during pregnancy except after special consideration and if it is absolutely necessary.
Breast-feeding
No safety data for NUTRYELT are available when it is administered during lactation.
Therefore, NUTRYELT should not be used during lactation except after special consideration and if it is absolutely necessary.
Fertility
No data available.
None stated.
If overdose is suspected, treatment with NUTRYELT should be withdrawn. Overdose should be confirmed by appropriate laboratory tests.
Ask anything about NUTRYELT concentrate for solution for infusion. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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