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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:  04/05/2017
 
Trade Name:  Visipaque
 
Generic Name or Proper Name (*):  iodixanol 320 mgI/mL
 
Indications Studied:  "Coronary computed tomography angiography (CCTA) to assist diagnostic evaluation of adults and pediatric patients 12 years and older with suspected coronary artery disease"
 
Label Changes Summary:  *Approved for use for CCTA in adults and pediatric patients 12 years and older. *Safety and efficacy have not been established in pediatric patients less than 12 years for CCTA. *Pediatric patients at higher risk of experiencing an adverse reaction during and after administration of any contrast agent may include those with asthma, hypersensitivity to other medication and/or allergens, cyanotic and acyanotic heart disease, congestive heart failure, or a serum creatinine greater than 1.5 mg/dL. Pediatric patients with immature renal function or dehydration may be at increased risk for adverse events due to slower elimination of iodinated contrast agents. *Information on safety, and dosing. *New indication.
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  GE HealthCare Inc.
 
NNPS:  FALSE
 
Therapeutic Category:  Medical imaging
 
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