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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 recommendedInformation on postmarketing clinical trial, adverse reactionsPostmarketing 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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