Nutryelt 10ml Concentrate for Solution For Infusion
What Nutryelt Is And What Nutryelt Used For
A nutrient is a concentrate for infusion solution. It contains nine essential trace elements.
- Iron
- Copper
- Manganese
- Zinc
- Fluorine
- Iodine
- Selenium
- Chromium
- Molybdenum
These trace elements are considered essential (necessary) because the body can not produce them but needs them in small amounts to function properly.
A nutrient provides adults who need intravenous nutrition (given in a vein) with trace elements.
What You Need To Know Before You Use Nutryelt
Do Not Use:
- If you are allergic (hypersensitive) to any of the ingredients of this medicine (listed in section 6).
- If you have abnormally high levels of any of the ingredients in the medicine in your blood. (If you are not sure, ask your doctor).
- If you have pronounced bile stasis (yellowing of the skin or whites of the eyes caused by liver or blood problems).
- If you have an excess of copper (Wilson’s disease) or iron in your body ( hemochromatosis ).
Warnings And Cautions
Talk to your doctor or pharmacist before using this medicine if:
- You have kidney problems
- You have liver problems such as mild bile stasis (impaired liver function with a yellowing of the skin or whites of the eyes)
- You get repeated blood transfusions
- You have diabetes and are taking insulin medicines
- You have thyroid problems, or if you are taking medicines containing iodine (eg iodine antiseptics).
During treatment, your doctor will regularly check the levels of trace elements in your blood, and he/she will then adjust the dose of Nutryelt accordingly.
Children
Nutryelt must not be used in children and adolescents.
Other Drugs And Nutryelt
Tell your doctor if you are taking, have recently taken, or might take any other medicines. Especially iron salts (taken by mouth).
Pregnancy And Breastfeeding
If you are pregnant or breastfeeding, 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 breastfeeding unless your doctor considers it necessary.
Nutrient Contains Sodium And Potassium
This medicine contains less than 1 mmol (23 mg) sodium per ampoule, ie essentially ‘sodium-free.’ This medicine contains less than 1 mmol (39 mg) potassium per ampoule, ie it is essentially ‘potassium-free.’
If you have any further questions about the use of this product, ask your doctor or pharmacist. Nutryelt is 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. Ask your doctor or pharmacist if you are unsure.
How To Use Nutryelt
Nutryelt Dilution Instructions Before Administration
- Nutryelt is not intended to be administered in its original form. For reconstitution, Nutryelt must be diluted or mixed by gentle shaking, under strictly aseptic conditions, before infusion.
- The nutrient must be diluted concerning final osmolarity. For example:
- 10 to 20 ml Nutryelt can be diluted with at least 250 ml of sodium chloride 0.9% solution for infusion
- 10 to 20 ml Nutryelt can be diluted with at least 250 ml of glucose 5% solution for infusion
- After diluting 20 ml of Nutryelt with 250 ml of 0.9% sodium chloride 0.9%, the pH value will be 3.3 or 3.3-3.4 if 5% glucose is used.
- The reconstituted infusion solution must be inspected visually before use. Only clear particulate solutions should be used.
- Do not store partially used containers, and discard all equipment after use.
- Compatibility with solutions administered simultaneously via a common entry cannula must be ensured.
- Trace elements accelerate the degradation of ascorbic acid in parenteral nutritional mixtures.
- 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 medicines.
- Dosage
- Your doctor will determine the right dose for you.
- The recommended daily dose is one ampoule (10 ml) Nutryelt. Your doctor may give you up to 2 ampoules per day.
Use For Children
Nutryelt must not be used in children and adolescents. A product designed for children and adolescents should give them trace elements when they need intravenous (into a vein) nutrition.
If You Take More Nutryelt Than You Should
Your doctor will discontinue your Nutryelt treatment and perform the necessary laboratory tests in case of a suspected overdose.
Possible Nutryelt Side Effects
This medicine can cause side effects like all medicines, although not everybody gets them. Tell your doctor if you notice any of the following:
Has been reported (affects an unknown number of users):
- Pain at the application site
Cases of hypersensitivity reactions, including fatal anaphylactic reactions, have been reported in patients receiving intravenous iron.
How To Store Nutryelt
- After dilution, chemical, and physical in-use stability has been demonstrated for 48 hours at 25 ° C and protected from light.
- From a microbiological point of view, the drug should be used immediately after dilution. If not used immediately, in-use storage times and conditions before administration are the user’s responsibility.
- Keep this medicine out of sight and reach of children.
- Do not use this medicine after the expiry date stated on the label after EXP. The expiration date is the last day of the specified month.
- Do not freeze.
- Store in the outer carton. Sensitive to light.
- Before use, check that the concentrate for the solution for infusion is homogeneous, that the bottle is not damaged, and that the solution is free of particles.
- Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer required. These measures will help to protect the environment.
Contents Of The Pack And Other Information
Content Declaration
The active substances are:
For 10 ml Nutryel
| Zinc (Zn) | 10000 micrograms | (as zinc gluconate) |
| Copper (Cu) | 300 micrograms | (as copper gluconate) |
| Manganese (Mn) | 55 micrograms | (as manganese gluconate) |
| Fluorine (F) | 950 micrograms | (as sodium fluoride) |
| Iodine (I) | 130 micrograms | (as potassium iodide) |
| Selenium (Se) | 70 micrograms | (as sodium selenite) |
| Molybdenum (Mo) | 20 micrograms | (as sodium molybdate) |
| Chrome (Cr) | 10 micrograms | (as chromium chloride) |
| Iron (Fe) | 1000 micrograms | (as iron gluconate) |
pH: 2.6 to 3.2
Osmolarity: 60 to 100 mosm / L
The other ingredients are hydrochloric acid and water for injections.
What The Medicine Looks Like And Contents Of The Pack
- Nutryelt is a clear, clear, and slightly yellow concentrate for solution infusion in a 10 ml ampoule.
- Nutryelt is packed in cartons with 4, 10, 25, and 50 ampoules.
- Not all pack sizes may be marketed.
Marketing Authorization Holder And Manufacturer
Marketing Authorization Holder Laboratoire Aguettant 1
rue Alexander Fleming
69007 Lyon
France
Manufacturer
Laboratoire Aguettant
Lieu-dit Chantecaille
07340 CHAMPAGNE
France