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 “thrombus formation on a prosthetic cardiac valve"
