Label Changes for:
Kytril (granisetron hydrochloride) Intravenous Injection
Changes have been made to the PRECAUTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – April 2011
8 Use in Special Populations
8.4 Pediatric Use
Postoperative Nausea and Vomiting
- Safety and efficacy have not been established in pediatric patients...Due to the lack of efficacy and the QT prolongation observed in this trial...