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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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