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.

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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 recommended dosage range.

( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Actavis at 1-800-432-8534 or FDA at 1-800-FDA-1088, or www.fda.gov/medwatch.