Label Changes for:

Dextrose 5%, Sodium Chloride 0.2%, and Potassium Chloride InjectionsPotassium Chloride in Dextrose 5% and Sodium Chloride Injections

September 2013

Changes have been made to the PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.

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

 

September 2013

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
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