Label Changes for:

Kytril (granisetron hydrochloride) Intravenous Injection

April 2011

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...
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