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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:  12/26/2017
 
Trade Name:  Draximage DTPA
 
Generic Name or Proper Name (*):  Technetium Tc99m Pentetate
 
Indications Studied:  Lung ventilation imaging and evaluation of pulmonary embolism when paired with perfusion imaging in adult and pediatric patients when administered by nebulizer for inhalation and for renal visualization, assessment of renal perfusion, and estimation of glomerular filtration rate
 
Label Changes Summary:  *Indicated in pediatric patients ages birth to less than 17 years of age. *Pediatric use is supported by evidence from controlled studies in adults and dosing and safety are based on clinical experience. *The radiation risk of Technetium Tc 99m pentetate is greater in pediatric patients than adults. *New route of administration and new indication.
 
PREA(P):  P
 
Sponsor:  Jubilant DraxImage, Inc.
 
NNPS:  TRUE
 
Therapeutic Category:  Medical imaging
 
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