Multrys^® (trace elements injection 4*, USP)
* Each mL of Multrys provides zinc 1,000 mcg, copper 60 mcg, manganese 3 mcg, and selenium 6 mcg. 

For intravenous use

INDICATIONS AND USAGE
Multrys is a combination of trace elements (zinc sulfate, cupric sulfate, manganese sulfate, and selenious acid) indicated in neonatal and pediatric patients weighing less than 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

DOSAGE AND ADMINISTRATION
Important Administration Information
Multrys is supplied as a single-dose vial. Prior to administration, Multrys 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 Multrys, correct severe fluid, electrolyte and acid-base disorders.  It is recommended only for patients who require supplementation with all four of the individual trace elements (zinc, copper, manganese and selenium).  Multrys is not recommended for patients who may require a lower dosage of one or more of the individual trace elements.  Avoid additional manganese supplementation with Multrys use.

CONTRAINDICATIONS
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 parenteral nutrition infusion and initiate a medical evaluation.
Vein Damage and Thrombosis: Solution with an osmolarity of 900 mOsmol/L or greater 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.  Discontinue Multrys and consider brain magnetic resonance imaging (MRI) if toxicity is suspected.  Monitor patients for cholestasis or other biliary liver disease.
Hepatic Accumulation of Copper and Manganese: Assess for development of hepatic accumulation. Monitor concentrations of copper and manganese in patients with cholestasis or cirrhosis.
Aluminum Toxicity: Multrys contains aluminum that may be toxic. Patients with renal impairment and preterm infants, including preterm neonates, are particularly at risk.
Monitoring and Laboratory Tests: Monitor blood zinc, copper and selenium serum concentrations, whole blood manganese concentration, fluid and electrolyte status, serum osmolarity, blood glucose, liver and kidney function, blood count, and coagulation parameters.
Hypersensitivity Reactions with Zinc and Copper: If hypersensitivity reactions occur, discontinue and initiate appropriate medical treatment.

ADVERSE REACTIONS
The following adverse reactions were identified in clinical studies or post-marketing reports:

• Neurologic toxicity with manganese
• Hepatic accumulation of copper and manganese
• Hypersensitivity reactions with zinc and copper

OVERDOSAGE
There are reports on overdosage in the literature for the individual trace elements.  

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.