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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:  02/23/2001
 
Trade Name:  Diprivan
 
Generic Name or Proper Name (*):  propofol
 
Indications Studied:  Induction and/or maintenance of anesthesia
 
Label Changes Summary:  * Maintenance of anesthesia- age decreased down to 2 months from 3 years * Induction of anesthesia remains the same- 3 years of age and above * Concomitant administration with fentanyl may result in serious bradycardia * Abrupt discontinuation following prolonged infusion may result in flushing of hands and feet, agitation, tremulousness and hyperirritability * Propofol is not indicated for pediatric ICU sedation as safety has not been established. In a single multicenter trial of ICU sedation in critically ill pediatric patients (patients with upper respiratory tract infections excluded), the incidence of mortality (causality not established) was 9% in the propofol arm versus 4% in the standard sedative agents arm
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B):  B
 
Sponsor:  AstraZeneca
 
Pediatric Exclusivity Granted Date:  08/11/1999
 
NNPS:  FALSE
 
Therapeutic Category:  Anesthetic agent
 
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