Trace Elements 4
Generic Name: trace elements 4
Brand Names:
Multitrace -4 Pediatric
DESCRIPTION MULTITRACE ® - 4 PEDIATRIC (TRACE ELEMENTS INJECTION 4, USP) is a sterile, nonpyrogenic solution containing four Trace Elements for use as an additive for Total Parenteral Nutrition (TPN). Each mL provides: Zinc 1 mg, Copper 0.1 mg, Manganese 25 mcg and Chromium 1 mcg.
Overview
DESCRIPTION MULTITRACE ® - 4 PEDIATRIC (TRACE ELEMENTS INJECTION 4, USP) is a sterile, nonpyrogenic solution containing four Trace Elements for use as an additive for Total Parenteral Nutrition (TPN). Each mL provides: Zinc 1 mg, Copper 0.1 mg, Manganese 25 mcg and Chromium 1 mcg.
Uses
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
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.
Side Effects
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.
Warnings
WARNINGS Copper and Manganese are eliminated via the bile. In patients with severe liver dysfunction and/or biliary tract obstruction, decreasing or omitting copper and manganese supplements entirely may be necessary. This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum. CONTRAINDICATIONS MULTITRACE ® - 4 PEDIATRIC should not be given undiluted by direct injection into a peripheral vein because of the potential of infusion phlebitis.
Pregnancy
Pregnancy Teratogenic Effects Pregnancy Category C: Safety for use in pregnancy has not been established. Use of MULTITRACE ® - 4 PEDIATRIC in women of childbearing potential requires that anticipated benefits be weighed against possible hazards.
Storage
HOW SUPPLIED MULTITRACE ® - 4 PEDIATRIC (TRACE ELEMENTS INJECTION 4, USP) Each mL provides: Zinc 1 mg, Copper 0.1 mg, Manganese 25 mcg, and Chromium 1 mcg. NDC 0517-9203-25 3 mL Single Dose Vial Packaged in boxes of 25 AMERICAN REGENT, INC. SHIRLEY, NY 11967 IN9203 Rev. 8/18
Frequently Asked Questions
What is Trace Elements 4 used for?▼
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.
What are the side effects of Trace Elements 4?▼
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.
Can I take Trace Elements 4 during pregnancy?▼
Pregnancy Teratogenic Effects Pregnancy Category C: Safety for use in pregnancy has not been established. Use of MULTITRACE ® - 4 PEDIATRIC in women of childbearing potential requires that anticipated benefits be weighed against possible hazards.
What are the important warnings for Trace Elements 4?▼
WARNINGS Copper and Manganese are eliminated via the bile. In patients with severe liver dysfunction and/or biliary tract obstruction, decreasing or omitting copper and manganese supplements entirely may be necessary. This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum. CONTRAINDICATIONS MULTITRACE ® - 4 PEDIATRIC should not be given undiluted by direct injection into a peripheral vein because of the potential of infusion phlebitis.
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.