Special Warning : אזהרת שימוש

4.4. Special warnings and precautions for use

The solution should be used after an accurate control of the patient clinical and biological parameters.
Blood manganese levels should be regularly monitored in case of prolonged artificial nutrition: dose reduction may be necessary or NUTRYELT infusion should be stopped if manganese levels rise into the potentially toxic range (please refer to appropriate reference ranges).

Particular attention must be paid when the product is given to patients with reduced biliary excretion, since it could interfere with the biliary elimination of manganese, copper and zinc, leading to accumulation and overdose.
NUTRYELT should be used with caution in patients with impaired renal function as excretion of some trace elements (selenium, fluoride, chromium, molybdenum and zinc) may be significantly decreased.
In patients with renal, hepatic impairments or mild cholestasis the posology should be adapted.

In patients undergoing medium to long-term parenteral nutrition, there is an increased occurence of iron, zinc and selenium deficiency. In such circumstances, when necessary, the dosage should be adapted with the use of an extra supply of solutions, which contain only these individual components.

For patients receiving repeated blood transfusions, a risk of iron overload can occur.

Parenterally administered iron preparations can cause hypersensitivity reactions including serious and potentially fatal anaphylactic/anaphylactoid reactions. The risk is enhanced for patients with known allergies including drug allergies

Chromium deficiency leads to a decrease in glucose tolerance, which improves after chromium supplementation. As a consequence, in diabetic patients on insulin medication, relative overdose of insulin and consecutive hypoglycemia may occur. Therefore controls of the blood glucose levels are recommended and re-adjustment of the insulin doses may become necessary.

NUTRYELT should be given with caution in cases of manifest hyperthyroidism or sensitivity to iodine if other iodine containing medicinal products (e.g. iodine antiseptics) are administered concomitantly.

This product contains 0.052 mmol of sodium (1.2 mg) per dose, i.e. essentially “sodium free”.
This product contains 0.001 mmol of potassium (0.039 mg) per dose, i.e. essentially “potassium-free”.

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