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U.S. Department of Health and Human Services

Safety

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Dextrose 5 percent, Sodium Chloride 0.2 percent, and Potassium Chloride Injections; Potassium Chloride in Dextrose 5 percent and Sodium Chloride Injections

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)

 

September 2013

Summary View

PRECAUTIONS 

  • added ..... risk of air embolism
Pediatric Use sections:
  • added ..... glucose monitoring and the risk of hypoglycemia and hyperglycemia
  • added .... the risk of hyponatremia

ADVERSE REACTIONS

  • added ..... the risk of hyponatremia
  • added ..... anaphylactic reactions