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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:  01/25/2012
 
Trade Name:  TISSEEL
 
Generic Name or Proper Name (*):  Fibrin Sealant*
 
Indications Studied:  Hemostasis: An adjunct to hemostasis in patients undergoing surgery when control of bleeding by conventional surgical techniques (such as suture, ligature, and cautery) is ineffective or impractical. TISSEEL is effective in heparinized patients. Sealing: An adjunct to standard surgical techniques (such as suture and ligature) to prevent leakage from colonic anastomoses following the reversal of temporary colostomies
 
Label Changes Summary:  See Package Insert for new information on biologics
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Baxter
 
Therapeutic Category:  Wound healing
 
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