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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
Sponsor:  Abbott
Pediatric Exclusivity Granted Date:  08/02/2000
Therapeutic Category:  Anesthetic agent