Safety, Pharmacokinetics, and Pharmacodynamics of Drotrecogin Alfa (Activated) in Children with Severe Sepsis

Pediatrics

Volumn 113, Issue 1 I, 2004, Pages 134-

  Weiss, Karen D ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

DROTRECOGIN;

ADULT; BLEEDING; BLOOD CLOTTING PARAMETERS; CHILD; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; GRAM NEGATIVE BACTERIUM; GRAM POSITIVE BACTERIUM; HUMAN; INFECTION; MAJOR CLINICAL STUDY; MULTICENTER STUDY; NOTE; PHARMACODYNAMICS; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SEPSIS; SIDE EFFECT; TREATMENT OUTCOME;

ADOLESCENT; APACHE; CHILD; CHILD, PRESCHOOL; FIBRINOLYTIC AGENTS; HUMANS; INFANT; INFANT, NEWBORN; PROTEIN C; RECOMBINANT PROTEINS; SEPSIS;

EID: 0346726129     PISSN: 00314005     EISSN: None     Source Type: Journal    
DOI: 10.1542/peds.113.1.134     Document Type: Note

References (3)

1. Barton P, Kalil AC, Nadel S, et al. Safety, pharmacokinetics, and pharmacodynamics of drotrecogin alfa (activated) in children with severe sepsis. Pediatrics. 2004;113:7-17
2. Bernard GR, Vincent JL, Laterre PF, et al. Efficacy and safety of recombinant human activated protein C for severe sepsis. N Engl J Med. 2001;344:699-709
3. Food and Drug Administration. Product approval information-licensing action. Available at: www.fda.gov/cder/biologics/products/droteli112101.htm. Accessed November 20, 2003