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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:
10/15/1998
Trade Name:
Versed
Generic Name or Proper Name (*):
midazolam
Indications Studied:
Sedation/anxiolysis/ amnesia
Label Changes Summary:
* Specified the effective dose, effective dose range, and time of onset * Defined volume of distribution and similarity to adult protein binding and elimination * Additional information on AE's and warnings about concomitant medications * Identified a subpopulation (children with congenital heart disease and pulmonary hypertension) at higher risk for AE's and the need to start therapy at the lower end of the dosing range
Product Labeling:
