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New Pediatric Labeling Information Database - Detail
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Pediatrics
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
PREA(P):
P
Sponsor:
Bracco Diagnostics
NNPS:
FALSE'
Therapeutic Category:
Diagnostic aid
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