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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:  05/05/2008
 
Trade Name:  Argatroban
 
Generic Name or Proper Name (*):  argatroban
 
Indications Studied:  Heparin-Induced Thrombocytopenia (HIT) or HIT with Thrombosis
 
Label Changes Summary:  * Safety and effectiveness, including the appropriate anticoagulation goals and duration of therapy, have not been established in pediatric patients * Population PK/PD analysis of sparse data in 15 seriously ill pediatric patients ages <6 months  16 years diagnosed with HIT or suspected HIT requiring an alternative to heparin anticoagulation showed clearance in pediatric patients was 50% lower compared to healthy adults and led to dose recommendations * Information on dose, AEs and PK
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B) and PREA(P):  B, P
 
Sponsor:  Encysive
 
NNPS:  FALSE
 
Therapeutic Category:  Hematology/Coagulation
 
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