Tralement
Tralement (trace elements injection 4, USP) is a sterile, non-pyrogenic combination of four trace elements — zinc, copper, manganese, and selenium — indicated as a source of these elements for parenteral nutrition in adult and pediatric patients weighing at least 10 kg when oral or enteral nutrition is not possible, insufficient, or contraindicated. It is a clear, colorless to slightly blue solution for intravenous infusion after admixing, supplied in single-dose and multiple-dose vials by American Regent, Inc.
Key Benefits:
• Provides all four essential trace elements (zinc, copper, manganese, and selenium) in a single, ready-to-admix product, simplifying parenteral nutrition preparation
• Approved for use in both adult and pediatric patients weighing at least 10 kg, with weight-based dosing guidance for pediatric patients from 10 kg to 49 kg
• Available in both 1 mL single-dose vials and 10 mL multiple-dose vials (up to 20 punctures), offering flexibility for different clinical settings
• Each mL delivers a fixed-combination dose: zinc 3 mg, copper 0.3 mg, manganese 55 mcg, and selenium 60 mcg
• Contains no preservative; vial closure is not made with natural rubber latex
Dosage & Administration:
Adults and pediatric patients weighing at least 50 kg: the recommended dosage is 1 mL per day added to parenteral nutrition. Pediatric patients weighing 10 kg to 49 kg: dosage is weight-based, ranging from 0.2 mL to 0.8 mL per day added to parenteral nutrition; additional supplementation with single trace element products may be needed for zinc, copper, and selenium in this population. Tralement must not be administered by direct intravenous infusion — it must be transferred to a parenteral nutrition container and used as an admixture. Blood concentrations of all four trace elements should be monitored during long-term parenteral nutrition administration.
Why Choose Tralement?
Tralement is a fixed-combination trace elements injection that delivers zinc, copper, manganese, and selenium in a single admixture additive, as described in its FDA-approved labeling (NDA 209376, initial U.S. approval 2020), providing a streamlined option for clinicians managing parenteral nutrition in patients who require supplementation with all four of these individual trace elements simultaneously.
Warnings:
• Neurologic toxicity with manganese: manganese accumulation in the basal ganglia has been reported with long-term parenteral nutrition, including neuropsychiatric symptoms and brain MRI findings; monitor for clinical signs of neurotoxicity and routinely check whole blood manganese concentrations and liver function tests
• Hepatic accumulation of copper and manganese: patients with cholestasis, biliary dysfunction, or cirrhosis are at increased risk; monitor hepatic and biliary function during long-term administration and consider individual trace element products as an alternative in affected patients
• Aluminum toxicity: Tralement contains aluminum that may reach toxic levels with prolonged parenteral administration in patients with impaired kidney function, including preterm infants; total daily aluminum exposure from the admixture should not exceed 5 mcg/kg/day
Disclaimer: This product description was generated by AI and is for informational purposes only. Please refer to the latest package insert for complete information on indications, contraindications, warnings, and proper use.
