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Manufacturer: American Regent

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Tralement™ Trace Elements 4 Injection, Single Dose Vial 1 mL, Each

Item Code: 000763
Mfg Part #: 00517-9305-01
$50.07
Requires Verified Medical License to Purchase
Cannot be Returned
To reduce overall packaging and shipping costs, our shipping department will pack your orders in as few boxes as possible. Compounded drugs must ship separately from our other products. When choosing Next Day or 2nd Day Air shipping methods, final shipping totals will be calculated when your order is packed and invoiced. Box size and package destination does not affect shipping fee calculations. The number of boxes is determined by size, weight and quantity of products ordered. For additional information or questions, please contact us.
About This Product

..

Products specifications
Medical License Required Yes
Class Rx Only
Product Name Injection
Generic Name Zinc / Copper / Manganese / Selenium
Route of Administration Intravenous (IV)
Strength Zinc 3 mg / Copper 0.3 mg / Manganese 55 mcg / Selenium 60 mcg
Volume 1 mL
Container Single Dose Vial
Storage Requirements USP Controlled Room Temperature
Storage Temperature 20º to 25ºC (68º to 77ºF)
Therapeutic Class Mineral Supplement

Tralement (Trace Elements Injection 4, USP)

Tralement (trace elements injection 4, USP) is a sterile, nonpyrogenic, fixed-combination intravenous solution containing four essential trace elements — zinc, copper, manganese, and selenium — in a single ready-to-admix product. Supplied by American Regent, Inc., it is indicated as a source of trace elements for adult and pediatric patients (≥10 kg) receiving parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. Available as a clear, colorless to slightly blue solution in 1 mL single-dose and 10 mL multiple-dose vials.

Key Benefits

  • All-in-One Trace Element Coverage: Delivers zinc 3 mg, copper 0.3 mg, manganese 55 mcg, and selenium 60 mcg per mL in a single admixture additive, simplifying parenteral nutrition preparation.
  • Broad Patient Eligibility: FDA-approved for both adult and pediatric patients weighing at least 10 kg, with weight-based dosing guidance for pediatric patients from 10 kg to 49 kg.
  • Flexible Vial Configurations: Available in 1 mL single-dose vials and 10 mL multiple-dose vials (up to 20 punctures) to accommodate varied clinical settings.
  • Preservative-Free and Latex-Free: Contains no preservative; vial closure is not manufactured with natural rubber latex.
  • FDA-Approved Labeling: Approved under NDA 209376 (initial U.S. approval 2020), providing a streamlined, regulatory-backed option for multi-trace element supplementation.

Dosage and Administration

Tralement must not be administered by direct intravenous infusion. It must be transferred to a parenteral nutrition container and delivered as an admixture only:

  • Adults and Pediatric Patients ≥50 kg: 1 mL per day added to parenteral nutrition.
  • Pediatric Patients 10 kg to 49 kg: Weight-based dosing of 0.2 mL to 0.8 mL per day added to parenteral nutrition; additional supplementation with single trace element products may be required for zinc, copper, and selenium in this population.
  • Monitoring: Blood concentrations of all four trace elements should be routinely monitored during long-term parenteral nutrition administration.

Why Choose Tralement?

  • Streamlined PN Preparation: Consolidates four trace elements into a single admixture step, reducing compounding complexity and preparation time.
  • Pediatric and Adult Versatility: One product supports both patient populations with individualized weight-based dosing, minimizing the need for multiple single-element products in qualifying patients.
  • Regulatory Confidence: FDA-approved under NDA 209376 with defined clinical labeling, supporting formulary justification and clinical protocol integration.

Warnings

  • Manganese Neurotoxicity: Long-term parenteral nutrition may cause manganese accumulation in the basal ganglia, resulting in neuropsychiatric symptoms and abnormal brain MRI findings; monitor for 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 of copper and manganese accumulation; monitor hepatic and biliary function during long-term use and consider individual trace element products as an alternative in affected patients.
  • Aluminum Toxicity: Contains aluminum that may reach toxic levels with prolonged parenteral administration, particularly in patients with renal impairment and 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 intended for informational purposes only. Please consult the latest package insert.

Products specifications

Tralement™ Trace Elements 4 Injection, Single Dose Vial 1 mL, 25/Tray

Item Code: 009938
Mfg Part #: 0517-9305-25
$1,124.99
Requires Verified Medical License to Purchase
Cannot be Returned
To reduce overall packaging and shipping costs, our shipping department will pack your orders in as few boxes as possible. Compounded drugs must ship separately from our other products. When choosing Next Day or 2nd Day Air shipping methods, final shipping totals will be calculated when your order is packed and invoiced. Box size and package destination does not affect shipping fee calculations. The number of boxes is determined by size, weight and quantity of products ordered. For additional information or questions, please contact us.
About This Product

..

Products specifications
Medical License Required Yes
Class Rx Only
Product Name Injection
Generic Name Zinc / Copper / Manganese / Selenium
Route of Administration Intravenous (IV)
Strength Zinc 3 mg / Copper 0.3 mg / Manganese 55 mcg / Selenium 60 mcg
Volume 1 mL
Container Single Dose Vial
Storage Requirements USP Controlled Room Temperature
Storage Temperature 20º to 25ºC (68º to 77ºF)
Therapeutic Class Mineral Supplement

Tralement (Trace Elements Injection 4, USP)

Tralement (trace elements injection 4, USP) is a sterile, nonpyrogenic, fixed-combination intravenous solution containing four essential trace elements — zinc, copper, manganese, and selenium — in a single ready-to-admix product. Supplied by American Regent, Inc., it is indicated as a source of trace elements for adult and pediatric patients (≥10 kg) receiving parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. Available as a clear, colorless to slightly blue solution in 1 mL single-dose and 10 mL multiple-dose vials.

Key Benefits

  • All-in-One Trace Element Coverage: Delivers zinc 3 mg, copper 0.3 mg, manganese 55 mcg, and selenium 60 mcg per mL in a single admixture additive, simplifying parenteral nutrition preparation.
  • Broad Patient Eligibility: FDA-approved for both adult and pediatric patients weighing at least 10 kg, with weight-based dosing guidance for pediatric patients from 10 kg to 49 kg.
  • Flexible Vial Configurations: Available in 1 mL single-dose vials and 10 mL multiple-dose vials (up to 20 punctures) to accommodate varied clinical settings.
  • Preservative-Free and Latex-Free: Contains no preservative; vial closure is not manufactured with natural rubber latex.
  • FDA-Approved Labeling: Approved under NDA 209376 (initial U.S. approval 2020), providing a streamlined, regulatory-backed option for multi-trace element supplementation.

Dosage and Administration

Tralement must not be administered by direct intravenous infusion. It must be transferred to a parenteral nutrition container and delivered as an admixture only:

  • Adults and Pediatric Patients ≥50 kg: 1 mL per day added to parenteral nutrition.
  • Pediatric Patients 10 kg to 49 kg: Weight-based dosing of 0.2 mL to 0.8 mL per day added to parenteral nutrition; additional supplementation with single trace element products may be required for zinc, copper, and selenium in this population.
  • Monitoring: Blood concentrations of all four trace elements should be routinely monitored during long-term parenteral nutrition administration.

Why Choose Tralement?

  • Streamlined PN Preparation: Consolidates four trace elements into a single admixture step, reducing compounding complexity and preparation time.
  • Pediatric and Adult Versatility: One product supports both patient populations with individualized weight-based dosing, minimizing the need for multiple single-element products in qualifying patients.
  • Regulatory Confidence: FDA-approved under NDA 209376 with defined clinical labeling, supporting formulary justification and clinical protocol integration.

Warnings

  • Manganese Neurotoxicity: Long-term parenteral nutrition may cause manganese accumulation in the basal ganglia, resulting in neuropsychiatric symptoms and abnormal brain MRI findings; monitor for 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 of copper and manganese accumulation; monitor hepatic and biliary function during long-term use and consider individual trace element products as an alternative in affected patients.
  • Aluminum Toxicity: Contains aluminum that may reach toxic levels with prolonged parenteral administration, particularly in patients with renal impairment and 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 intended for informational purposes only. Please consult the latest package insert.

Products specifications
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Products specifications
Medical License Required Yes
Class Rx Only
Product Name Injection
Generic Name Zinc / Copper / Manganese / Selenium
Route of Administration Intravenous (IV)
Strength Zinc 3 mg / Copper 0.3 mg / Manganese 55 mcg / Selenium 60 mcg
Volume 1 mL
Container Single Dose Vial
Storage Requirements USP Controlled Room Temperature
Storage Temperature 20º to 25ºC (68º to 77ºF)
Therapeutic Class Mineral Supplement

Coronavirus (COVID-19)

Due to the Coronavirus (COVID-19) outbreak worldwide, the global demand for some Personal Protective Equipment (PPE) is exceeding current supply availability.

In addition, the manufacturing of the PPE and many other wound care/infection prevention products have been impacted by the global response to the Coronavirus. While you may see product availability reduction in the near-term, please be assured that we at McGuff Medical are continuing to work diligently to ensure an uninterrupted supply of products and alternative products to you.

Additionally, in order to ensure healthcare providers have access to the PPEs they need, the McGuff Company is temporarily limiting PPEs to healthcare providers.

As always, please feel free to reach out to our McGuff Customer Service team with any questions that you may have.

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