Trace Elements 5

Generic Name: trace elements 5

Over-the-Counter (OTC)

Brand Names:

Multitrace-5

DESCRIPTION MULTITRACE ® - 5 (TRACE ELEMENTS INJECTION 5, USP) is a sterile nonpyrogenic solution containing five Trace Elements for use as an additive for Total Parenteral Nutrition (TPN). Each mL provides: Zinc 1 mg, Copper 0.4 mg, Manganese 0.1 mg, Chromium 4 mcg and Selenium 20 mcg.

Overview

DESCRIPTION MULTITRACE ® - 5 (TRACE ELEMENTS INJECTION 5, USP) is a sterile nonpyrogenic solution containing five Trace Elements for use as an additive for Total Parenteral Nutrition (TPN). Each mL provides: Zinc 1 mg, Copper 0.4 mg, Manganese 0.1 mg, Chromium 4 mcg and Selenium 20 mcg.

Uses

INDICATIONS AND USAGE This formulation is indicated for use as a supplement to intravenous solutions given for TPN. Administration of the solution in TPN solutions helps to maintain plasma levels of zinc, copper, manganese, selenium 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 0.4 mg, Manganese 0.1 mg, Chromium 4 mcg, and Selenium 20 mcg. The suggested dosage ranges for the five trace elements are: ZINC : For the metabolically stable adult receiving TPN, the suggested intravenous dosage level is 2.5 to 4 mg zinc/day. An additional 2 mg zinc/day is suggested for acute catabolic states. For the stable adult with fluid loss from the small bowel, an additional 12.2 mg zinc/liter of small bowel fluid lost, or an additional 17.1 mg zinc/kg of stool or ileostomy output is recommended. Frequent monitoring of zinc blood levels is suggested for patients receiving more than the usual maintenance dosage level of zinc. Normal plasma levels for zinc vary from approximately 88 to 112 mcg/100 mL.

Side Effects

ADVERSE REACTIONS The amounts of ZINC, COPPER, MANGANESE, CHROMIUM and SELENIUM 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 ® - 5 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: SELENIUM at high dosage levels (15-30 mcg/egg) has been reported to have adverse embryological effects among chickens. There are however no adequate and wellcontrolled studies in pregnant women. MULTITRACE ® - 5 should be used during pregnancy only if potential benefit justifies the potential risk to the fetus. Presence of SELENIUM in placenta and umbilical cord blood has been reported in humans.

Storage

HOW SUPPLIED MULTITRACE ® - 5 (TRACE ELEMENTS INJECTION 5, USP) Each mL provides: Zinc 1 mg, Copper 0.4 mg, Manganese 0.1 mg, Chromium 4 mcg, Selenium 20 mcg. NDC 0517-8510-25 10 mL Multiple Dose Vial* Packaged in boxes of 25 *Contains 0.9% benzyl alcohol as an antimicrobial preservative. AMERICAN REGENT, INC. SHIRLEY, NY 11967 IN8510 Rev. 8/18

Frequently Asked Questions

What is Trace Elements 5 used for?

INDICATIONS AND USAGE This formulation is indicated for use as a supplement to intravenous solutions given for TPN. Administration of the solution in TPN solutions helps to maintain plasma levels of zinc, copper, manganese, selenium 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 5?

ADVERSE REACTIONS The amounts of ZINC, COPPER, MANGANESE, CHROMIUM and SELENIUM 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 5 during pregnancy?

Pregnancy Teratogenic Effects Pregnancy Category C: SELENIUM at high dosage levels (15-30 mcg/egg) has been reported to have adverse embryological effects among chickens. There are however no adequate and wellcontrolled studies in pregnant women. MULTITRACE ® - 5 should be used during pregnancy only if potential benefit justifies the potential risk to the fetus. Presence of SELENIUM in placenta and umbilical cord blood has been reported in humans.

What are the important warnings for Trace Elements 5?

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 ® - 5 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.