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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:  03/01/2017
 
Trade Name:  Liquid E-Z-Paque
 
Generic Name or Proper Name (*):  barium sulfate
 
Indications Studied:  Use in single contrast radiographic examinations of the esophagus, stomach, and small bowel to visualize the gastrointestinal (GI) tract in adult and pediatric patients
 
Label Changes Summary:  *Efficacy in pediatric patients from birth to less than 17 years of age is based on successful opacification of the esophagus, stomach, and small bowel during single contrast radiographic procedures. * Safety and dosing recommendations in pediatric patients are based on clinical experience. * 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. Monitor pediatric patients with cystic fibrosis or Hirschsprung disease for bowel obstruction after use. * Information on dosing.
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Bracco Diagnostics
 
NNPS:  FALSE
 
Therapeutic Category:  Medical Imaging
 
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