TRACUTIL CONCENTRATE FOR

Posology Adults The recommended daily dose in adult patients with basal requirements is 10 ml (1 ampoule). In patients with moderately increased requirements the daily dose may be up to 20 ml (2 ampoules), accompanied by monitoring of the trace element status.

In cases of significantly increased trace element requirements (such as extensive burns, severe hypercatabolic polytraumatic patients) higher doses may be necessary. 3). 4). Renal and hepatic impairment The doses for patients with impaired hepatic and/or renal function should be determined individually.

For these patients lower doses may be required. g. 9% w/v, Ringer’s solution). Compatibility must be tested before addition to other infusion solutions. The infusion of the ready-to-use mixture should not take less than 6 hours and should be completed within 24 hours.

Administration can be continued for the duration of parenteral nutrition. 2. 6.

Notes:

Diarrhoea may lead to increased intestinal loss of zinc. The serum concentrations must be checked in this case. Deficiencies of individual trace elements must be corrected by specific supplementation.

Immune system disorder:

Not known: Anaphylactic reactions to parenterally administered iron, with possible fatal outcome. Iodine may cause allergic reactions. Reporting of suspected adverse reactions Reporting of 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

Manganese blood levels should be regularly monitored in case of prolonged artificial nutrition. Dose reduction may be necessary, or Tracutil infusion should be stopped, if manganese accumulates. Tracutil should be used with caution in case of impaired hepatic function, which may impair the biliary elimination of manganese, copper and zinc, leading to accumulation and overdose.

This trace element solution should be used with caution in case of impaired renal function, as excretion of some trace elements (selenium, fluoride, chromium, molybdenum and zinc) may be significantly decreased. To prevent iron overload, which is a risk mainly in patients with impaired hepatic function or those receiving blood transfusions, serum ferritin levels should be monitored at regular intervals.

In patients undergoing medium to long-term parenteral nutrition, there is an increased frequency of zinc and selenium deficiency. g. , when necessary the dose should be adapted and an extra supply of these elements should be provided.

g. iodine antiseptics) are administered concomitantly. Chromium deficiency leads to a decrease in glucose tolerance, which improves after chromium supplementation. Then in diabetic patients on insulin medication, relative overdose of insulin and consecutive hypoglycaemia may result.

Therefore checks of the blood glucose levels are recommended. Re-adjustment of the insulin doses may become necessary. Paediatric population Tracutil is not recommended in adolescents due to lack of specific studies. e. essentially ‘sodium-free’.

e. haemosiderosis or haemochromatosis). Tracutil is contraindicated in neonates, infants and children as its composition is not suitable for this age group.