Each 1-mL solution contains zinc chloride 521 mcg, copper chloride·2H20 53.7 mcg, manganese chloride·4H20 3.6 mcg, sodium selenite·5H20 6.66 mcg, sodium fluoride 126 mcg, potassium iodide 1.31 mcg, hydrochloric acid to pH 2 and water for injections to 1 mL. Peditrace is a sterile solution containing trace elements for addition to amino acid solution or glucose solution (see Compatibility under Dosage & Administration) in the parenteral nutrition of premature and full-term infants and children. The content of trace elements in Peditrace is as follows: See Table 1.
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Osmolality: 38 mOsmol/kg water. pH: 2.
Indications/Uses
Peditrace is intended to meet the basal requirement of trace elements during IV nutrition of infants and children. Peditrace is a trace element additive solution for pediatric patients on total parenteral nutrition.
Dosage/Direction for Use
Peditrace must be given diluted. 1 mL of Peditrace/kg body weight/day is administered to infants and children up to 15 kg. For children ≥15 kg, a daily dose of 15 mL meets the basic needs for trace elements. The infusion time should be at least 8 hrs. Treatment monitoring: If treatment is continued for >4 weeks, the levels of manganese must be monitored. In the case of long-term IV nutrition, plasma levels of trace elements should also be monitored. Miscibility: Up to 6 mL Peditrace may be added to 100 mL Vaminolac, Vamin 14 g N/1 electrolyte-free or glucose solution 50-500 mg/mL. If mixtures containing Peditrace are to be administered, see Table 2.
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Contraindications
Patients with Wilson's disease.
Special Precautions
In conditions in which excretion in the bile is reduced and/or in the case of renal insufficiency, Peditrace should be used with caution in patients with biochemically or clinically demonstrated hepatic dysfunction (particularly cholestasis). Trace element levels in plasma must be monitored in patients with cholestatic liver disease and renal insufficiency. Copper and manganese are excreted normally with the bile, while selenium and zinc (particularly in patients given IV nutrition) are for the most part excreted with the urine. Peditrace is a concentrated additive solution of trace elements. Iron is not present in it.
Storage
Store at 25°C. Do not freeze. Shelf-Life: If additives to infusion liquids are carried out on the ward, the infusion should, in view of the contamination risk, be used immediately. The contents of a broken bottle must be discarded and must not be saved for a later occasion. If additives are made using strictly aseptic methods on the environmental bench at the pharmacy, the mixture must be used within 96 hrs. This mixture must be stored at 5±3°C and be infused within 24 hrs after the bag has been taken out of the cold storage.
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