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New Pediatric Labeling Information Database - Detail
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Pediatrics
New Pediatric Labeling Information Database
Detail
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Pediatric Labeling Date:
12/22/2016
Trade Name:
Lumason
Generic Name or Proper Name (*):
Sulfur Hexafluoride Lipid-Type A Microspheres
Indications Studied:
Evaluation of suspected or known vesicoureteral reflux in pediatric patients
Label Changes Summary:
*Effectiveness in pediatric patients has been established for use in ultrasonography of the urinary tract for the evaluation of suspected or known vesicoureteral reflux from two published studies comprising a total of 411 pediatric patients. *Safety of intravesical use of Lumason was based on evaluation of published literature involving use of Lumason in over 6000 pediatric patients. No adverse reactions were reported. *Information on published studies. *New indication.
Product Labeling:
Labeling
PREA(P):
P
Sponsor:
Bracco Diagnostics
NNPS:
FALSE
Therapeutic Category:
Medical Imaging
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