Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
New Pediatric Labeling Information Database - Detail
FDA Home
Pediatrics
New Pediatric Labeling Information Database
Detail
-
Please note:
JavaScript must be enabled for this application to work properly.
Check your settings
if you are unsure if your JavaScript is enabled.
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
BPCA(B) and PREA(P):
B, P
Sponsor:
Organon USA
Pediatric Exclusivity Granted Date:
04/03/2008
NNPS:
FALSE'
Therapeutic Category:
Anesthetic agent
-
-