Label Changes for:

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)

  • 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

PRECAUTIONS

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

ADVERSE REACTIONS

  • Added ..... the risk of hyponatremia

 

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