Valine, Lysine, Histidine, Isoleucine, Leucine, Phenylalanine, Threonine, Methionine, Tryptophan, Alanine, Glycine, Arginine, Proline, Glutamic Acid, Serine, Aspartic Acid And Tyrosine

1 INDICATIONS AND USAGE PROSOL is indicated as a source of amino acids for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. PROSOL may be used to treat negative nitrogen balance in patients. • PROSOL is indicated as a source of amino acids for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. PROSOL may be used to treat negative nitrogen balance in patents. ( 1 )

6 ADVERSE REACTIONS The following serious adverse reactions are discussed in greater detail in other sections of the prescribing information. • Pulmonary embolism due to pulmonary vascular precipitates [see Warnings and Precautions (5.1) ] • Hypersensitivity reactions [see Warnings and Precautions (5.2) ] • Risk of infections [see Warnings and Precautions (5.3) ] • Refeeding syndrome [see Warnings and Precautions (5.4) ] • Hyperglycemia or hyperosmolar hyperglycemic state [see Warnings and Precautions (5.5) ] • Vein damage and thrombosis [see Warnings and Precautions (5.6) ] • Hepatobiliary disorders [see Warnings and Precautions (5.7) ] • Aluminum toxicity [see Warnings and Precautions (5.8) ] • Parenteral Nutrition Associated Liver Disease [see Warnings and Precautions (5.9) ] • Electrol...

8.1 Pregnancy Risk Summary Limited published data with injectable amino acids solutions, including PROSOL in pregnant women are not sufficient to inform a drug associated risk for adverse developmental outcomes. However, malnutrition in pregnant women is associated with adverse maternal and fetal outcomes [see Clinical Considerations ]. Animal reproduction studies have not been conducted with injectable amino acids solutions, including PROSOL. The background risk of major birth defects and miscarriage for the indicated population is unknown.

5 WARNINGS AND PRECAUTIONS • Pulmonary Embolism due to Pulmonary Vascular Precipitates: if signs of pulmonary distress occur, stop the infusion and initiate a medical evaluation. ( 5.1 ) • Hypersensitivity Reactions: monitor for signs and symptoms and discontinue infusion if reactions occur. ( 5.2 ) • Risk of Infections, Refeeding Complications, and Hyperglycemia or Hyperosmolar Hyperglycemic State: monitor for signs and symptoms; monitor laboratory parameters. ( 5.3 , 5.4 , 5.5 ) • Vein Damage and Thrombosis: solutions with osmolarity of 900 mOsmol/L or more must be infused through a central catheter. ( 2.2 , 5.6 ) • Hepatobiliary Disorders: monitor liver function parameters and ammonia levels. 4 CONTRAINDICATIONS The use of PROSOL is contraindicated in: • Patients with known hypersensitivity to one or more amino acids [see Warnings and Precautions (5.2) ]. • Patients with inborn errors of amino acid metabolism due to risk of severe metabolic or neurologic complications. • Patients with pulmonary edema or acidosis due to low cardiac output.