Tralement .3 mg/mL
Trace Elements Injection 4 · INJECTION, SOLUTION · American Regent, Inc.
Trace Elements Injection 4 is an intravenous medication containing essential trace minerals that are added to nutritional support solutions for patients who cannot obtain adequate trace elements through normal eating. This injection helps prevent trace element deficiencies in patients receiving long-term intravenous nutrition.
Key Facts
- Brand Name
- Tralement
- Generic Name
- Trace Elements Injection 4
- NDC Code (Product)
0517-9305- Manufacturer
- American Regent, Inc.
- Strength
- .3 mg/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- NDA209376
- Marketing Start
- 09/29/2020
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 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. Tralement is a combination of trace elements (zinc sulfate, cupric sulfate, manganese sulfate and selenious acid) 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. ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Single-dose vial amd multiple-dose vial . Not for direct intravenous infusion. ( 2.1 ) See full prescribing information for information on preparation, administration and general dosing considerations. ( 2.1 , 2.2 , 2.3 , 2.4) Recommended Dosage Each mL of Tralement provides zinc 3 mg, copper 0.3 mg, manganese 55 mcg, and selenium 60 mcg. ( 2.5 ) Adults and Pediatric Patients Weighing at Least 50 kg : The recommended dosage of Tralement is 1 mL per day added to parenteral nutrition. Tralement is not recommended for patients who may require a lower dosage of one or more of the individual trace elements. ( 2.5 ) 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. Tralement does not provide the recommended daily dosage of zinc (in heavier patients in some weight bands), copper or selenium. Additional supplementation using single trace element products may be needed for these patients. For complete dosing information see table in the full prescribing information. ( 2.4 , 2.5 ) Monitor trace element concentrations in blood during long-term administrati…
Contraindications
4 CONTRAINDICATIONS Tralement is contraindicated in patients with hypersensitivity to zinc or copper [ see Warnings and Precautions ( 5.7 )]. Hypersensitivity to zinc or copper ( 4, 5.7 )
Adverse Reactions
6 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 [ see Warnings and Precautions ( 5. 1 )] • Vein damage and thrombosis [ see Warnings and Precautions ( 5.2 )] • Aluminum toxicity [see Warnings and Precautions ( 5.5 )] Adverse reactions with the use of trace elements administered parenterally or by other routes of administration : • Neurologic toxicity with manganese [see Warnings and Precautions ( 5.3 )] • Hepatic accumulation of copper and manganese [see Warnings and Precautions ( 5.4 )] • Hypersensitivity reactions with zinc and copper [ see Warnings and Precautions ( 5.7) ] No adverse reactions related to zinc, copper, selenium, or manganese have been reported in patients receiving intravenously administered parenteral solutions containing these trace elements within the…
Frequently Asked Questions
What is Tralement used for?
Trace Elements Injection 4 is an intravenous medication containing essential trace minerals that are added to nutritional support solutions for patients who cannot obtain adequate trace elements through normal eating. This injection helps prevent trace element deficiencies in patients receiving long-term intravenous nutrition.
Is Tralement a controlled substance?
Tralement is not classified as a controlled substance by the DEA.
What is the generic name for Tralement?
The generic name for Tralement is Trace Elements Injection 4. There are 1 other brand versions of Trace Elements Injection 4.
What is the NDC code for Tralement .3 mg/mL?
The NDC (National Drug Code) for Tralement .3 mg/mL is 0517-9305, listed by American Regent, Inc..