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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:
08/25/2017
Trade Name:
Dotarem
Generic Name or Proper Name (*):
gadoterate meglumine
Indications Studied:
Contrast agent for intravenous use with magnetic resonance imaging (MRI) in brain (intracranial), spine and associated tissues to detect and visualize areas with disruption of the blood brain barrier and/or abnormal vascularity
Label Changes Summary:
*Expanded indication down to term neonates; previously approved for use in 2 years and older. *A non-randomized study with 28 pediatric patients under 2 years who were referred for contrast MRI of the CNS supported extrapolation of CNS efficacy findings from adults and older children. *Safety has not been established in preterm neonates. *No cases of Nephrogenic Systemic Fibrosis associated with Dotarem or any other gadolinium-based contrast agents have been identified in pediatric patients age 6 years and younger. *Information on dosing, PK parameters, adverse reactions in pediatric patients, and clinical trial.
Product Labeling:
Labeling
PREA(P):
P
Sponsor:
Guerbet
NNPS:
FALSE
Therapeutic Category:
Medical imaging
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