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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:  09/08/2010
 
Trade Name:  Protopam**
 
Generic Name or Proper Name (*):  pralidoxime
 
Indications Studied:  Treatment of poisoning due to organophosphates (e.g., nerve agents)
 
Label Changes Summary:  * Expanded indication from adults to pediatrics * Efficacy extrapolated from adult population and supported by nonclinical studies, PK studies in adults and experience in the pediatric population * Information on IV and IM dosing, and adverse events
 
Product Labeling:  Labeling  Opens a new window
 
Sponsor:  Baxter
 
NNPS:  TRUE
 
Therapeutic Category:  Antidote
 
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