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New Pediatric Labeling Information Database - Detail
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Pediatrics
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
PREA(P):
P
Sponsor:
Hoffman- LaRoche
NNPS:
FALSE'
Therapeutic Category:
Antiemetic
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