AMR SVG Icons location

 

Helpful Information about the Multiple Trace Elements Product Transition

As part of our ongoing efforts to develop FDA approved products that align with the American Society for Parenteral and Enteral Nutrition (ASPEN) guidelines, American Regent has voluntarily ceased manufacturing of Multitrace®-4 Pediatric (trace elements injection 4, USP). While our supply has been depleted, your wholesaler may have inventory for a limited time. Both Tralement® (trace elements injection 4*) and Multitrace-4 Neonatal are readily available.

As the leader in the multiple trace element market in the United States, American Regent is committed to providing appropriate trace element supplementation to all parenteral nutrition patients. We have demonstrated this by launching Tralement® (trace elements injection 4*), a trace element supplement that may be used in patients over 10 kg.  In addition, we are developing a new trace element formulation for patients under 10 kg that we hope to launch in the early Fall.

American Regent is committed to providing adequate supply of Tralement® and Multitrace®-4 Neonatal until we have launched an approved trace element formulation that can meet the needs of patients weighing less than 10 kg. 

View Frequently Asked Questions

To assist you in planning for this product transition, please see the table below.

 

Product Name

Tralement®

Multitrace®-4 Neonatal

Multitrace®-4 Pediatric

Pack NDC

0517-9305-25

0517-6202-25

0517-9203-25

Marketing Status

FDA Approved

Marketed Unapproved

Marketed Unapproved

Availability Status

Available

Available

Out of Stock

Vial Size

1 mL

2 mL

3 mL

Trace Elements Content per/mL

Zinc

3 mg

Zinc

1.5 mg

Zinc

1 mg

Copper

0.3 mg

Copper

0.1 mg

Copper

0.1 mg

Manganese

55 mcg

Manganese

25 mcg

Manganese

25 mcg

Selenium

60 mcg

Chromium

0.85 mcg

Chromium

1 mcg

Full Prescribing Information

Tralement®

Multitrace®-4 Neonatal

Multitrace®-4 Pediatric

*Each mL contains zinc 3 mg, copper 0.3 mg, manganese 55 mcg, and selenium 60 mg

 

Managing the Multitrace®-4 Pediatric (trace elements injection, USP) Inventory Transition

Frequently Asked Questions


  1. Where can I view the inventory status of Multitrace®-4 Pediatric?
    To view the current inventory status of Multitrace®-4 Pediatric and all of American Regent’s offerings, please visit the “Our Products” page at www.americanregent.com.

  2. Why did American Regent voluntarily decide to cease manufacturing Multitrace®-4 Pediatric?
    We have voluntarily ceased manufacturing of Multitrace®-4 Pediatric as part of our effort to develop FDA-approved products that align with the American Society for Parenteral and Enteral Nutrition (ASPEN) guidelines. We are currently developing a new trace element formulation for patients under 10 kg that we hope to launch in the early fall. In the meantime, Tralement® (trace elements injection 4*, USP) and Multitrace®-4 Neonatal are available. To help inform your product selection, refer to the Full Prescribing Information regarding dosing and administration for each product,
    at www.americanregent.com.

    *Each mL of Tralement® contains zinc 3 mg, copper 0.3 mg, manganese 55 mcg, and selenium 60 mcg.

  3. What is Tralement®?
    Tralement® is an FDA-approved, multi-trace element injection. 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.

  4. How is Tralement® dosed?
    Pediatric Patients Weighing 10 kg to 49 kg: The recommended dosage of Tralement® based on body weight is 0.2 mL to 0.8 mL per day added to parenteral nutrition.
    Adults and Pediatric Patients Weighing at Least 50 kg: The recommended dosage of Tralement® is 1 mL per day added to parenteral nutrition.

    For complete dosing instructions, please see the Full Prescribing Information for Tralement®.

  5. What is Multitrace®-4 Neonatal?
    Multitrace®-4 Neonatal is an additive for parenteral nutrition. It is supplied in a 2 mL single dose vial that provides zinc 1.5 mg, copper 0.1 mg, manganese 25 mcg, and chromium 0.85 mcg per 1 mL. Full Prescribing Information

  6. Where can I find more information on how to properly supplement patients requiring parenteral nutrition with trace elements?
    Please visit www.nutritioncare.org for information on the practice of clinical nutrition, and parenteral nutrition dosing guidelines from the American Society for Parenteral and Enteral Nutrition (ASPEN).

  7. Will there be a new trace elements formulation for patients under 10 kg in the future?
    American Regent plans to launch an updated trace elements formulation for patients weighing less than 10 kg in early Fall.

 

Sign up to receive updates on the inventory transition as well as the launch of our new trace element formulation

 

 

By clicking submit, you confirm that you accept our privacy policy and that you agree to your personal contact information being used to contact you and added to our database.  If at any time you wish your personal information be removed from the American Regent database, please submit a message request to corpcommunications@americanregent.com

Tralement® is a Registered Trademark of American Regent, Inc. Patents pending.

Contact Us

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.

CONTRAINDICATIONS
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.

ADVERSE REACTIONS
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.

REF-1535  08/2020