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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:  11/13/2019
 
Trade Name:  Lumason
 
Generic Name or Proper Name (*):  Sulfur Hexafluoride Lipid-Type A Microspheres
 
Indications Studied:  Use in echocardiography to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border in adult and pediatric patients with suboptimal echocardiograms
 
Label Changes Summary:  *Safety and effectiveness have been established for use in pediatric patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improve delineation of the left endocardial border. *Safety and effectiveness in pediatric patients are based on adequate and well-controlled studies in adults and are supported by a clinical study in 12 pediatric patients with extrapolation of efficacy to younger pediatric patients. *No new adverse reactions were reported in the pediatric study. *Safety of intravenous use of Lumason was based on evaluation of published literature involving the use of Lumason in over 1400 pediatric patients (0 to 17 years). *Information on dosing, adverse reactions, and clinical trial. *Postmarketing study.
 
PREA(P):  P
 
Sponsor:  Bracco Diagnostics
 
Therapeutic Category:  Medical imaging
 
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