Cupric sulfate, Manganese sulfate, Selenious acid and Zinc sulfate

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.

Zinc Zinc functions as a cofactor of various enzymes including DNA polymerases, RNA polymerases, alcohol dehydrogenase, and alkaline phosphatases. Zinc is a coordinator of protein structural folding that interacts with a variety of proteins, lipids, and nucleic acids. In addition, zinc is a catalyst of essential biochemical reactions, including activation of substrates of carbonic anhydrase in erythrocyte. Copper Copper is a cofactor for many metalloenzymes acting as an oxidase to achieve reduction of molecular oxygen.

Single-dose vial amd multiple-dose vial. Not for direct intravenous infusion. See full prescribing information for information on preparation, administration and general dosing considerations. Recommended Dosage Each mL of Tralement provides zinc 3 mg, copper 0.3 mg, manganese 55 mcg, and selenium 60 mcg. 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. 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.

Tralement is contraindicated in patients with hypersensitivity to zinc or copper. Hypersensitivity to zinc or copper

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. Neurologic Toxicity with Manganese: Monitor for clinical signs and symptoms of neurotoxicity, whole blood manganese concentrations and liver function tests in patients receiving long-term Tralement. Discontinue Tralement and consider brain magnetic resonance imaging (MRI) if toxicity suspected. ( 5. 3) 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.

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.

Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F). Store admixed solution at 2ºC to 8ºC (36ºF to 46ºF).