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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
Therapeutic Category:  Anesthetic agent