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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:  06/01/2011
 
Trade Name:  KEDBUMIN
 
Generic Name or Proper Name (*):  Albumin (Human)*
 
Indications Studied:  Hypovolemic shock, Hypoalbuminemia, Prevention of central volume depletion after paracentesis due to cirrhotic ascites, Ovarian Hyperstimulation Syndrome (OHSS), Adult Respiratory Distress Syndrome (ARDS), Burns, Hemodialysis patients undergoing long term dialysis, Patients who cannot tolerate substantial volumes of salt solution, Priming solution for cardiopulmonary bypass
 
Label Changes Summary:  See Package Insert for new information on biologics
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Kedrion, S.p.A.
 
NNPS:  TRUE
 
Therapeutic Category:  albumin
 
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