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U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail

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Pediatric Labeling Date:  04/29/2011
 
Trade Name:  Kytril Injection
 
Generic Name or Proper Name (*):  granisetron hydrochloride
 
Indications Studied:  Prevention of postoperative nausea and vomiting
 
Label Changes Summary:  * Safety and efficacy have not been established in pediatric patients for the prevention of postoperative nausea and vomiting (PONV)* Due to the lack of efficacy and the QT prolongation observed in this trial, use for the prevention of PONV in children is not recommended* Information on postmarketing clinical trial, adverse reactions* Postmarketing PREA required study
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Hoffman- LaRoche
 
NNPS:  FALSE
 
Therapeutic Category:  Antiemetic
 
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