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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:  03/08/2004
 
Trade Name:  Ultiva
 
Generic Name or Proper Name (*):  remifentanil
 
Indications Studied:  Maintenance of anesthesia
 
Label Changes Summary:  * Safety and efficacy for the maintenance of anesthesia established from birth to 1 year of age * Recommended dosing guidelines for maintenance of anesthesia for patients from birth to 2 months * The clearance rate observed in neonates was highly variable  approximately 2 times higher than young healthy adults * Individual doses for each patient should be carefully titrated
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B) and PREA(P):  B, P
 
Sponsor:  Abbott
 
Pediatric Exclusivity Granted Date:  03/15/2000
 
NNPS:  FALSE
 
Therapeutic Category:  Anesthetic agent
 
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