Pedtrace
INDICATIONS
Pedtrace®-4 is indicated for use as a supplement to intravenous solution given for TPN. Administration of Pedtrace®-4 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 in pediatric patients.
DOSAGE AND ADMINISTRATION
The suggested dosage ranges for the four trace elements in neonates and pediatric patients are:
| ZINC: | For full term infants and children up to 5 years of age, 100 mcg zinc/kg/day is recommended. For premature infants 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. |
| MANGANESE: | For pediatric patients, a dosage of 2 to 10 mcg manganese/kg/day is suggested. |
| CHROMIUM: | For pediatric patients, the suggested additive dosage 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 preparation.
Aseptic addition of Pedtrace®-4 to the TPN solution under a laminar wflow hood is recommended. The trace elements present in Pedtrace®-4 are physically compatible with the electrolytes and vitamins usually present in the amino acid/dextrose solution used for TPN.
Parenteral drug products should be visually inspected for particulate matter and discoloration prior to administration, whenever solution and container permit.
HOW SUPPLIED
| Product No. | NDC No. | |
| 13803 | 0469-1380-03 | Pedtrace®-4 in a 3 mL single-dose, flip-top vial in packages of 25. |
| 13810 | 0469-1380-30 | Pedtrace®-4 in a 10 mL single-dose, flip-top vial in packages of 25. |
Store at controlled room temperature 15°-30°C (59°-86°F).
Preservative Free. Discard unused portion.
CAUTION: Federal law prohibits dispensing without prescription.
Generic Name: Pediatrace
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Pedtrace
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