NUTRYELT CONCENTRATE FOR

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.

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. 6.

The following adverse reaction(s) have been reported during post-marketing experience of trace elements solutions. The frequency is not known (cannot be estimated from the available data). System organ class (SOC) MedDRA Preferred Term GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Pain at the application site Cases of hypersensitivity reactions including fatal anaphylactic reactions have been reported in patients receiving IV iron-containing products.

Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store

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. g. iodine antiseptics) are administered concomitantly. e. essentially “sodium free”. e. essentially “potassium-free”.

1 - in cases of Wilson’s disease and hemochromatosis - if serum concentrations of any of the trace elements contained in NUTRYELT are elevated.