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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:  12/29/2014
 
Trade Name:  Gadavist
 
Generic Name or Proper Name (*):  gadobutrol
 
Indications Studied:  Detection and visualization of areas with disrupted blood brain barrier (BBB) and/or abnormal vascularity of the central nervous system
 
Label Changes Summary:  *Extended the indication to pediatric patients from bith at age 37 weeks gestation up to 2 years of age, based on two adequate and well controlled studies in 44 ages 0 to less than 2 years and extrapolation from of adult CNS efficacy data *The frequency, type, and severity of adverse reactions in pediatric patients were similar to those in adults. *Dosing established [0.1 mL/kg body weight (0.1 mmol/kg)] *PK studies suggest that clearance of Gadavist is similar in pediatric patients and adults, including pediatric patients age younger than 2 years *Juvenile toxicity studies in rats did not reveal findings suggestive of a specific risk for use in pediatric patients including term neonates and infants
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Bayer
 
Therapeutic Category:  Medical Imaging
 
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