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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:
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
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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