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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:
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
BPCA(B) and PREA(P):
B, P
Sponsor:
Encysive
NNPS:
FALSE'
Therapeutic Category:
Hematology/Coagulation
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