The first and only FDA-Approved multi-trace element injection for parenteral nutrition.1
Tralement™ (trace elements injection 4*, USP) is indicated in adult and pediatric patients weighing at least 10 kg as a source of zinc, copper, manganese and selenium for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated.2
Aligns with Current Treatment Guidelines
Tralement™ has been specifically developed to align with the ASPEN recommendations for trace element supplementation. The concentration of each element in new Tralement™ has been formulated to meet the needs of a broad range of pediatric and adult patients.2,3
Dosing: Added to Parenteral Nutrition
A 1 mL dose of Tralement™ per day for adults and pediatric patients weighing at least 50 kg simplifies treatment planning and preparation for healthcare workers, may save time, and may reduce the likelihood of errors.2,4 Weight-dependent dosing is provided for pediatric patients between 10 kg to 49 kg.2 Tralement™ is not recommended for patients who may require a lower dosage of one or more of the individual trace elements.
Stability studies support that Tralement™ can be safely stored for up to 9 days when added to the parenteral nutrition admixture and refrigerated.2
Tralement™ is proudly manufactured in America. American Regent is committed to providing a consistent supply to help ensure that your patient care needs are met.
Tralement™ aligns with the daily recommendations for parenteral trace elements set forth by ASPEN.2,3
Refer to the table below for specifications on Tralement™ as it compares to the select unapproved trace element products offered by American Regent.
See the Important Safety Information for Tralement™ below, in addition to the product’s Full Prescribing Information.
For more information on Tralement™, click here.
1. Approved Drug Products with Therapeutic Equivalence Evaluations:
Accessed August 4, 2020.
2. Tralement™ (trace elements injection 4*, USP) [package insert]. Shirley, NY: American Regent, Inc. 2020.
3. American Society for Parenteral and Enteral Nutrition (ASPEN) website: http://www.nutritioncare.org/uploadedFiles/Documents/Guidelines_and_Clinical_Resources/PN%20Dosing%201-Sheet-FINAL.pdf.
Accessed July 20, 2020.
4. Vanek et al. A Call to Action to Bring Safer Parenteral Micronutrient Products to the U.S. Market. Nutr Clin Pract. Aug. 2015; 30 (4):559-569.
5. Multitrace®-4 Neonatal (trace elements injection 4, USP) [package insert]. Shirley, NY: American Regent, Inc. Aug. 2018.
6. Multitrace®-4 Pediatric (trace elements injection 4, USP) [package insert]. Shirley, NY: American Regent, Inc. Aug. 2018.
7. Multitrace®-5 Concentrate (trace elements injection 5, USP) [package insert]. Shirley, NY: American Regent, Inc. Aug. 2018.
Tralement™ is a trademark of American Regent, Inc.
Important Information on the Multiple Trace Element Product Line Transition
Helping you plan your inventory of Multiple Trace Element Products
During the first two weeks of November 2019, American Regent notified customers of our intent to stop manufacturing certain Multitrace® SKUs. We are currently supplying the following three products:
As discussed with the FDA, we will cease distribution of Multitrace®-5 Concentrate, 1 mL Single Dose Vial upon commercial availability of Tralement™ (trace elements injection 4, USP) 1 mL.
After the availability of new FDA Approved Tralement™ we will offer the following multi-trace element products:
(8:30am–6pm Monday - Thursday and Friday 8:30am–5pm Eastern Time)
P: 888-354-4859E: firstname.lastname@example.org
(9am–5pm Eastern Time, Monday - Friday)
Tralement™ (trace elements injection 4*, USP)
For intravenous use
INDICATIONS AND USAGE
Tralement™ is indicated in adult and pediatric patients weighing at least 10 kg as a source of zinc, copper, manganese, and selenium for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated.
IMPORTANT SAFETY INFORMATION
Important Administration Information
Tralement is supplied as a single-dose vial for admixture use only. It is not for direct intravenous infusion. Prior to administration, Tralement must be transferred to a separate parenteral nutrition container, diluted and used as an admixture in parenteral nutrition solution.
Overview of Dosing
- Prior to administration of parenteral nutrition solution containing Tralement, correct severe fluid, electrolyte, and acid-base disorders.
- The dosage of the final parenteral nutrition solution containing Tralement must be based on the concentrations of all components in the solution, the patient’s clinical condition, nutritional requirements, and the contribution of oral or enteral intake.
Tralement is recommended only for patients who require supplementation with all four of the individual trace elements (i.e., zinc, copper, manganese and selenium).
See Full Prescribing Information on preparation, administration and dosing.
Tralement is contraindicated in patients with hypersensitivity to zinc or copper.
WARNINGS AND PRECAUTIONS
- Pulmonary Embolism due to Pulmonary Vascular Precipitates: If signs of pulmonary distress occur, stop the infusion and initiate a medical evaluation.
- Vein Damage and Thrombosis: Solutions with osmolarity of 900 mOsmol/L or more must be infused through a central catheter. The primary complication of peripheral access is venous thrombophlebitis.
- Neurologic Toxicity with Manganese: Monitor patients receiving long-term parenteral nutrition solutions containing Tralement for neurologic signs and symptoms and routinely monitor whole blood manganese concentrations and liver function tests. Discontinue Tralement and consider brain magnetic resonance imaging (MRI) if toxicity suspected.
- Hepatic Accumulation of Copper and Manganese: Assess for development of hepatic or biliary dysfunction. Monitor concentrations of copper and manganese in patients with cholestasis, biliary dysfunction or cirrhosis receiving Tralement long-term.
- Aluminum Toxicity: Tralement contains aluminum that may be toxic. Increased risk in patients with renal impairment, including preterm infants.
- Monitoring and Laboratory Tests: Monitor blood zinc, copper, manganese, and selenium concentrations, fluid and electrolyte status, serum osmolarity, blood glucose, liver and kidney function, blood count and coagulation parameters.
- Hypersensitivity Reactions with Zinc and Copper: If reactions occur, discontinue Tralement and initiate appropriate medical treatment.
The following adverse reactions were identified in clinical studies or post-marketing reports. Given that some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Adverse reactions with other components of parenteral nutrition solutions:
- Pulmonary embolism due to pulmonary vascular precipitates
- Vein damage and thrombosis
- Aluminum toxicity
Adverse reactions with the use of trace elements administered parenterally or by other routes of administration:
- Neurologic toxicity with manganese
- Hepatic accumulation of copper and manganese
- Hypersensitivity reactions with zinc and copper
USE IN SPECIFIC POPULATIONS
Pregnancy - Risk Summary - Deficiency of trace elements may result in adverse pregnancy and fetal outcomes.
Lactation - Risk Summary - Zinc, copper, manganese, and selenium are present in human milk. The developmental and health benefits of breastfeeding should be considered, along with the mother’s clinical need for Tralement and any potential adverse effects on the breastfed infant from Tralement or from the underlying maternal condition.
Pediatric Use – Refer to Full Prescribing Information for dosing. Do not supplement Tralement with additional manganese. Tralement is not approved for use in pediatric patients weighing less than 10 kg.
Hepatic Impairment - Hepatic accumulation of copper and manganese have been reported with long-term administration in parenteral nutrition. For patients with cholestasis, biliary dysfunction, or cirrhosis, monitor hepatic and biliary function during long-term administration of Tralement.
OVERDOSAGE - There are reports on overdosage in the literature for the individual trace elements. Management of overdosage is supportive care based on presenting signs and symptoms.
For additional safety information, please see Full Prescribing Information.
You are encouraged to report Adverse Drug Events to American Regent Inc. at 1-800-734-9236, or to the FDA by visiting www.fda.gov/medwatch or by calling 1-800-FDA-1088.