Label Changes for:

Heparin Sodium in 5 percent Dextrose Injection in Excel

January 2013

Changes have been made to the WARNINGS sections of the safety label.

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

 

25,000 units in Dextrose
10,000 units in Dextrose

January 2013

WARNINGS

Heparin-induced Thrombocytopenia (HIT) (With or Without Thrombosis)
  • to include ‚Äúthrombus formation on a prosthetic cardiac valve"
Hide
(web5)