Label Changes for:
Definity Vial for (Perflutren Lipid Microsphere) Injectable Suspension
Changes have been made to the BOXED WARNING, WARNINGS, PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – October 2011
- Serious cardiopulmonary reactions, including fatalities, have occurred uncommonly during or following perflutren-containing microsphere administration [see WARNINGS AND PRECAUTIONS (5.1)]. Most serious reactions occur within 30 minutes of administration.....
WARNINGS AND PRECAUTIONS
Serious Cardiopulmonary Reactions, and:
- minor changes in both sections.....
- Reported reactions included: ......
USE IN SPECIAL POPULATIONS
- In clinical trials, the overall incidence of adverse reactions was similar for the <65 year age group and the ≥65 year age group. Of the total .....