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U.S. Department of Health and Human Services

Safety

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Sodium Chloride Injections and Ringers Injection

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

  • 0.9% Sodium Chloride Injection, USP in VIAFLEX Plastic Container
  • 0.9% Sodium Chloride Injection, USP in AVIVA Plastic Container
  • 0.45% Sodium Chloride Injection, USP in VIAFLEX Plastic Container
  • 0.45% Sodium Chloride Injection, USP in AVIVA Plastic Container
  • Ringer’s Injection, USP

 

September 2013

Summary View

PRECAUTIONS

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

ADVERSE REACTIONS

  • Added ..... the risk of hyponatremia