Trace Elements 4

INDICATIONS AND USAGE This formulation is indicated for use as a supplement to intravenous solutions given for TPN for children up to 11 years of age. Administration of the solution in TPN solutions helps to maintain plasma levels of zinc, copper, manganese, and chromium and to prevent depletion of endogenous stores of these trace elements and subsequent deficiency symptoms.

DOSAGE AND ADMINISTRATION Each mL of the solution provides Zinc 1 mg, Copper 0.1 mg, Manganese 25 mcg, and Chromium 1 mcg, and is administered intravenously only after dilution to a minimum of 1:200. The suggested dosage ranges for the four trace elements are: ZINC : For full term infants and children, 100 mcg zinc/kg/day is recommended. For premature infants (birth weight less than 1500 g) up to 3 kg in body weight, 300 mcg zinc/kg/day is suggested. COPPER : For pediatric patients, the suggested additive dosage level is 20 mcg copper/kg/day. The normal plasma range for copper is approximately 80 to 160 mcg/100 mL. MANGANESE : For pediatric patients, a dosage level of 2 to 10 mcg manganese/kg/day is recommended. CHROMIUM : For pediatric patients, the suggested additive dosage level is 0.14 to 0.20 mcg/kg/day. Periodic monitoring of plasma levels of Zinc, Copper, Manganese, and Chromium is suggested as a guideline for administration. Aseptic addition of MULTITRACE® - 4 PEDIATRIC to parenteral nutrition solutions under a laminar flow hood is recommended. The trace elements present in MULTITRACE® - 4 PEDIATRIC are physically compatible with the electrolytes and vitamins usually present in parenteral nutrition formulations. Do not directly mix ascorbic acid injection with copper or selenium containing parenteral products in the same syringe or vial, as this admixture may cause the formation of an insoluble precipitate. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) (See USP Controlled Room Temperature).

ADVERSE REACTIONS The amounts of ZINC, COPPER, MANGANESE, AND CHROMIUM in the solution are very small and toxicity symptoms due to these trace elements at suggested dosage levels are considered unlikely to occur.