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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:
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
BPCA(B):
B
Sponsor:
AstraZeneca
Pediatric Exclusivity Granted Date:
08/11/1999
NNPS:
FALSE'
Therapeutic Category:
Anesthetic agent
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