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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:  10/14/2016
 
Trade Name:  Varibar Pudding
 
Generic Name or Proper Name (*):  barium sulfate
 
Indications Studied:  Evaluate the oral and pharyngeal function and morphology in adults and pediatric patients 6 months of age and older
 
Label Changes Summary:  * Efficacy in pediatric patients above 6 months of age is based on successful opacification of the pharynx during modified barium swallow examinations. * Safety and dosing recommendations in pediatric patients above 6 months of age are based on clinical experience. * Varibar Pudding is contraindicated in pediatric patients with tracheo-esophageal fistula. * Pediatric patients with a history of asthma or food allergies may be at increased risk for development of hypersensitivity reactions. Pediatric patients with cystic fibrosis or Hirschsprung disease should be monitored for bowel obstruction after use. *Information on dosing. * New drug
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Bracco Diagnostics
 
NNPS:  FALSE
 
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