1 INDICATIONS AND USAGE 2.5% Dextrose and 0.45% Sodium Chloride Injection is indicated as a source of water, electrolytes and calories.

2.5% Dextrose and 0.45% Sodium Chloride Injection is indicated as a source of water, electrolytes and calories.

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6 ADVERSE REACTIONS The following adverse reactions associated with the use of 2.5% Dextrose and 0.45% Sodium Chloride Injection were identified in postmarketing reports.

Because 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.

The following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity Reactions: anaphylaxis, rash and pruritus [see Warnings and Precautions ( 5.1 )] .

Metabolism and Nutrition Disorders: hyperglycemia [see Warnings and Precautions ( 5.2 )] , hyponatremia and hyponatremic encephalopathy, for solutions containing less than 0.9% sodium chloride [see Warnings and Precautions ( 5.3 )] .

Hypernatremia and hyperchloremia acidosis [see Warnings and Precautions ( 5.5 )] have been observed in solutions containing 0.9% sodium chloride.

Infusion and/or Injection Site Reactions: phlebitis, injection site vesicles, infusion site pain, chills and pyrexia.

Adverse reactions include electrolyte imbalances, hyperglycemia, and hypervolemia and injection site reactions.

( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .