INFUTRAZE CONCENTRATE FOR

0 mL Infutraze per kg body weight covers basal requirements of the included trace elements. 5 mL Infutraze per kg body weight covers basal requirements of the included trace elements.

Children weighing more than 20 kg and adolescents:

A recommended maximum daily dose of 10 mL Infutraze covers basal requirements of the included trace elements. 6 micrograms In addition to the trace elements contained in Infutraze, daily iron infusions are recommended if patients receive parenteral nutrition for more than 3 weeks.

Addition of molybdenum to parenteral nutrition is recommended if patients receive parenteral nutrition for more than 4 weeks. For instructions on dose adjustments in specific patient groups, see section

No adverse effects related to infusion of a similar trace element product by Fresenius have been reported. 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

4 Method of administration Infutraze must not be given undiluted. Infutraze shall be given as an intravenous infusion, diluted in a parenteral nutrition solution/emulsion. The rate and duration of infusion is determined by the rate and duration of infusion of the parenteral nutrition solution.

6. 1. - Wilson’s disease. 4 Special warnings and precautions for use Infutraze should be used with caution in patients with impaired renal function, in whom the excretion of selenium, zinc and iodine may be significantly decreased. There is an increased risk of trace element accumulation in those patients.

Infutraze should be used with caution in patients with liver dysfunction (especially cholestasis) in whom excretion of copper and manganese may be decreased. In patients with impaired biliary excretion, elimination of manganese, copper, and zinc may be reduced.

Clinical signs of trace element accumulation may require dose reduction or interruption of Infutraze use in those patients. Dose adjustments might be needed in patients with impaired renal function and impaired liver function or mild cholestasis.

Infutraze should be used with caution in patients with hyperthyroidism. , goitre). No adjustment of Infutraze is required in case of additional intake of iodine through iodine-based antiseptic. , essentially ‘sodium-free’. , essentially ‘potassium-free’.

Long-term parenteral nutrition In patients receiving long-term parenteral nutrition, accumulation of trace elements might occur, especially of manganese. If the treatment is continued for more than 4 weeks, manganese levels should be monitored.

, anxiety, rapid eye movements) may indicate possible manganese overload, which may also arise from certain medical conditions and from parenteral nutrition. Manganese accumulation may require dose reduction or interruption of Infutraze use.

1. - Wilson’s disease.