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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:  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: