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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:  03/30/2001
 
Trade Name:  Ultane
 
Generic Name or Proper Name (*):  sevoflurane
 
Indications Studied:  Induction and maintenance of general anesthesia
 
Label Changes Summary:  * New study in pediatric patients 9 days-12 years comparing sevoflurane and halothane * Precautions section and Adverse Events During Post-Marketing subsection updated to add information on the rare cases of seizures that have been reported in pediatric patients in association with sevoflurane use. The majority of cases were in children and young adults, most of whom had no medical history of seizures * Pediatric information consolidated into new Pediatric Use subsection
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B):  B
 
Sponsor:  Abbott
 
Pediatric Exclusivity Granted Date:  08/02/2000
 
NNPS:  FALSE
 
Therapeutic Category:  Anesthetic agent
 
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