Multitrace-4 Neonatal
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Questions & Answers
Side Effects & Adverse Reactions
MULTITRACE® - 4 NEONATAL is a hypotonic solution which should be administered in admixtures only. Supplementation of TPN solutions with Neonatal Formula should be immediately discontinued if toxicity symptoms due to any of the constituent trace elements in Neonatal Formula is observed in the patient.
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.
Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
MULTITRACE® - 4 NEONATAL is indicated for use as a supplement to intravenous solutions given for TPN. Administration of MULTITRACE® - 4 NEONATAL 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.
History
There is currently no drug history available for this drug.
Other Information
MULTITRACE® - 4 NEONATAL (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 1.5 mg
Copper 0.1 mg
Manganese 25 mcg
Chromium 0.85 mcg
Each mL contains:
Zinc Sulfate (Heptahydrate) 6.6 mg
Cupric Sulfate (Pentahydrate) 0.39 mg
Manganese Sulfate (Monohydrate) 77 mcg
Chromic Chloride (Hexahydrate) 4.36 mcg
Water for Injection q.s
pH (range 2.3-2.7) may be adjusted with Sulfuric Acid and/or Sodium Hydroxide.
Zinc Sulfate is chemically designated ZnSO4, a white crystalline compound freely soluble in water. Cupric Sulfate is chemically designated CuSO4, a blue crystalline compound very soluble in water. Manganese Sulfate is chemically designated MnSO4, a pale red, slightly efflorescent compound soluble in water. Chromic Chloride is chemically designated CrCl3, a greenish compound, soluble in water.
Sources
Multitrace-4 Neonatal Manufacturers
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American Regent, Inc.
![Multitrace-4 Neonatal (Trace Elements 4) Injection, Solution [American Regent, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Multitrace-4 Neonatal | American Regent, Inc.
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 0.14 to 0.20 mcg chromium/kg/day.
Periodic monitoring of plasma levels of Zinc, Copper, Manganese and Chromium is suggested as a guideline preparation.
Aseptic addition of MULTITRACE® - 4 NEONATAL to the TPN solution under a laminar flow hood is recommended. The trace elements present in the Neonatal Formula 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.
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