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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:  12/15/2006
 
Trade Name:  Suprane
 
Generic Name or Proper Name (*):  desflurane
 
Indications Studied:  Safety study of 2 agents used for maintenance of anesthesia in non-intubated patients
 
Label Changes Summary:  * Not indicated for maintenance of anesthesia in non-intubated pediatric patients * In a clinical safety trial in patients 2 - 16 years, desflurane and isoflurane were compared for maintenance of anesthesia in non-intubated patients to assess the incidence of respiratory adverse events. Desflurane was associated with higher rates of coughing, laryngospasm and secretions with an overall rate of respiratory events of 39%. 5% of pediatric patients 2-16 years old exposed to desflurane, experienced severe laryngospasm * The incidence of respiratory events was highest in children aged 2-6 years; therefore, similar studies in children under the age of 2 years were not initiated. * Additional information on clinical studies and AEs
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B):  B
 
Sponsor:  Baxter
 
Pediatric Exclusivity Granted Date:  09/13/2006
 
NNPS:  FALSE
 
Therapeutic Category:  Anesthetic agent
 
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