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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:  08/28/2008
 
Trade Name:  Zemuron
 
Generic Name or Proper Name (*):  rocuronium
 
Indications Studied:  Adjunct to general anesthesia
 
Label Changes Summary:  * Expanded pediatric indication to include 0-17 years. Previously approved in ages 3 months  14 years * Not recommended for rapid sequence intubation in pediatric patients * In clinical studies of rocuronium, onset time and clinical duration varied with dose, the age of the patient, and anesthetic technique * The overall analysis of ECG data in pediatric patients indicates that the concomitant use of rocuronium with general anesthetic agents can prolong the QTc interval * The time to maximum block for an intubating dose was shortest in infants and longest in neonates. The duration of clinical relaxation following an intubating dose is shortest in children > 2 years to 11 years and longest in infants * Additional information on dose, clinical studies, and PK/PD parameters
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B) and PREA(P):  B, P
 
Sponsor:  Organon USA
 
Pediatric Exclusivity Granted Date:  04/03/2008
 
NNPS:  FALSE
 
Therapeutic Category:  Anesthetic agent
 
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