Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail
  • Print
  • Share
  • E-mail
-
 
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
 
-
-