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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:  03/17/2010
 
Trade Name:  MultiHance Injection
 
Generic Name or Proper Name (*):  gadobenate dimeglumine
 
Indications Studied:  Intravenous use in magnetic resonance imaging
 
Label Changes Summary:  Extended indication from adults to pediatric patients 2 years and older Safety and effectiveness in pediatric patients less than 2 years have not been established Patients less than 2 years may be at increased risk of nephrogenic systemic fibrosis related to gadolinium due to immature kidney function Adverse events similar to adult patients Information on adverse events, PK, and clinical studies New indication
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Bracco Diagnostics
 
NNPS:  FALSE'
 
Therapeutic Category:  Diagnostic aid
 
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