PEDITRACE CONCENTRATE FOR

Posology Adults and elderly:

The trace element solution Additrace should be used in adults and elderly.

Paediatric population:

Infants and children (weighing 15 kg or less): Basal requirements of the included trace elements are covered by 1 ml Peditrace per kg body weight per day to a maximum daily dose of 15 ml.

Children (weighing 15 kg or more):

A daily dose of 15 ml Peditrace should meet basal trace element requirements. However, for patients weighing more than 40 kg the adult preparation Additrace should be used. Method of administration Peditrace should not be given undiluted.

Peditrace administration should not be started until kidney function is established – usually during the second day of life. The infusion should be given at a very slow rate (minimum infusion period is 8 hours) and is best done with an appropriate pump or an automatic drop rate counter.

As the requirements of trace elements may vary in different clinical conditions, these substances may have to be added as appropriate in the individual patient. Potassium and sodium requirements also vary with different clinical conditions.

Peditrace is not intended to meet these requirements. Patients who are likely to lose higher than average amounts of trace elements, or those requiring prolonged intravenous nutrition should be monitored bio- chemically to confirm that requirements are being appropriately met.

Impaired renal or hepatic excretion may lead to chronic overdose of one or more trace elements. 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.

Administration should be carried out under specialist surveillance, especially in patients with pre-existing imbalances, in renal failure or in hepatic disease. Peditrace should be used with caution in conditions where excretion in the bile is reduced, particularly when cholestatic liver disease is present and/or when urinary excretion is markedly reduced.

Patients with such conditions require careful biochemical monitoring as the excretion of trace elements may also be significantly decreased. Patients requiring long term total parenteral nutrition (TPN) (defined as longer than one month) should have a baseline whole blood or serum manganese level within or below the normal range and normal liver function before receiving Peditrace.

Manganese levels and liver function should be monitored regularly (monthly) while the patient is maintained on Peditrace. Peditrace should be stopped if manganese levels rise into the potentially toxic range (please refer to appropriate reference ranges for the testing laboratory), or if cholestasis develops.

1. Wilson’s disease.