Medication Guide App

Label Changes for:

5% Dextrose and 0.9% Sodium Chloride Injection, USP in Plastic Container2.5% Dextrose and 0.45% Sodium Chloride Injection, USP in Plastic Container5% Dextrose and 0.2% Sodium Chloride Injection, USP in Plastic Container10% Dextrose and 0.9% Sodium Chloride Injection, USP in Plastic Container5% Dextrose and 0.45% Sodium Chloride Injection, USP in Plastic Container5% Dextrose and 0.33% Sodium Chloride Injection, USP in Plastic Container

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)

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

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

 

Hide
(web4)