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U.S. Department of Health and Human Services

Safety

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Dextrose and Sodium Chloride Injection, USP in Plastic Container

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

5% Dextrose and 0.9% Sodium Chloride Injection, USP in Plastic Container
2.5% Dextrose and 0.45% Sodium Chloride Injection, USP in Plastic Container
5% Dextrose and 0.2% Sodium Chloride Injection, USP in Plastic Container
10% Dextrose and 0.9% Sodium Chloride Injection, USP in Plastic Container
5% Dextrose and 0.45% Sodium Chloride Injection, USP in Plastic Container
5% Dextrose and 0.33% Sodium Chloride Injection, USP in Plastic Container

 

September 2013

Summary View

PRECAUTIONS

  • added ..... the risk of air embolism (Viaflex labels only)
Pediatric Use
  • 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