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Kytril (granisetron hydrochloride) Intravenous Injection
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...