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Volumn 37, Issue 1, 2009, Pages 327-329

Recombinant human activated protein C, package labeling, and hemorrhage risks

Author keywords

bleeding; Prescription drug labeling; Recombinant human activated protein C

Indexed keywords

DROTRECOGIN; HEPARIN; ROSUVASTATIN; ANTIINFECTIVE AGENT; PROTEIN C; RECOMBINANT PROTEIN;

EID: 59649090795     PISSN: 00903493     EISSN: 15300293     Source Type: Journal    
DOI: 10.1097/CCM.0b013e3181935102     Document Type: Editorial
Times cited : (14)

References (15)
  • 1
    • 0035826096 scopus 로고    scopus 로고
    • Efficacy and safety of recombinant human activated protein C for severe sepsis
    • 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
    • (2001) N Engl J Med , vol.344 , pp. 699-709
    • Bernard, G.R.1    Vincent, J.L.2    Laterre, P.F.3
  • 2
    • 0037179685 scopus 로고    scopus 로고
    • Risks and benefits of activated protein C treatment for severe sepsis
    • Warren HS, Suffredini AF, Eichacker PQ, et al: Risks and benefits of activated protein C treatment for severe sepsis. N Engl J Med 2002; 347:1027-1030
    • (2002) N Engl J Med , vol.347 , pp. 1027-1030
    • Warren, H.S.1    Suffredini, A.F.2    Eichacker, P.Q.3
  • 3
    • 84881597719 scopus 로고    scopus 로고
    • Indianapolis, Indiana, Available at:, Accessed November 20, 2008
    • Product Information - Xigris. Eli Lilly and Co., Indianapolis, Indiana. 2007. Available at: http://www.xigris.com/330-safety.jsp. Accessed November 20, 2008
    • (2007) Product Information - Xigris. Eli Lilly and Co
  • 4
    • 59649104743 scopus 로고    scopus 로고
    • Adverse outcomes associated with the use of dro-trecogin alfa (activated) in patients with severe sepsis and baseline bleeding precautions
    • Gentry CA, Gross KB, Sud B, et al: Adverse outcomes associated with the use of dro-trecogin alfa (activated) in patients with severe sepsis and baseline bleeding precautions. Crit Care Med 2009; 37:19-25
    • (2009) Crit Care Med , vol.37 , pp. 19-25
    • Gentry, C.A.1    Gross, K.B.2    Sud, B.3
  • 5
    • 33847361454 scopus 로고    scopus 로고
    • Use of Drotrecogin alfa (activated) in Italian intensive care units: The results of a nationwide survey
    • Bertolini G, Rossi C, Anghileri A, et al: Use of Drotrecogin alfa (activated) in Italian intensive care units: The results of a nationwide survey. Intensive Care Med 2007; 33: 426-434
    • (2007) Intensive Care Med , vol.33 , pp. 426-434
    • Bertolini, G.1    Rossi, C.2    Anghileri, A.3
  • 6
    • 33847422269 scopus 로고    scopus 로고
    • Evaluating the use of Drotrecogin alfa (activated) in adult severe sepsis: A Canadian multicenter observational study
    • Kanji S, Perreault MM, Chant C, et al: Evaluating the use of Drotrecogin alfa (activated) in adult severe sepsis: A Canadian multicenter observational study. Intensive Care Med 2007; 33:517-523
    • (2007) Intensive Care Med , vol.33 , pp. 517-523
    • Kanji, S.1    Perreault, M.M.2    Chant, C.3
  • 7
    • 34548456526 scopus 로고    scopus 로고
    • Prophylactic heparin in patients with severe sepsis treated with Drotrecogin alfa (activated)
    • Levi M, Levy M, Williams MD, et al: Prophylactic heparin in patients with severe sepsis treated with Drotrecogin alfa (activated). Am J Respir Crit Care Med 2007; 176: 483-490
    • (2007) Am J Respir Crit Care Med , vol.176 , pp. 483-490
    • Levi, M.1    Levy, M.2    Williams, M.D.3
  • 8
    • 2942577600 scopus 로고    scopus 로고
    • Safety of Drotrecogin alfa (activated): Results of MERCURY, a retrospective multicenter observation study
    • Steingrub J, Sanchez P, Zeckel M, et al: Safety of Drotrecogin alfa (activated): Results of MERCURY, a retrospective multicenter observation study. Crit Care Med 2003; 31: A117
    • (2003) Crit Care Med , vol.31
    • Steingrub, J.1    Sanchez, P.2    Zeckel, M.3
  • 9
    • 34547130140 scopus 로고    scopus 로고
    • Use of Drotrecogin alfa (activated) (Xigris) for the treatment of severe sepsis: Medical use evaluation by Novation, the supply company of VHA and UHC
    • Tanzi M: Use of Drotrecogin alfa (activated) (Xigris) for the treatment of severe sepsis: Medical use evaluation by Novation, the supply company of VHA and UHC. Novation 2004
    • (2004) Novation
    • Tanzi, M.1
  • 10
    • 37549009522 scopus 로고    scopus 로고
    • A retrospective observational study of Drotrecogin alfa (activated) in adults with severe sepsis: Comparison with a controlled clinical trial
    • Wheeler A, Steingrub J, Schmidt GA, et al: A retrospective observational study of Drotrecogin alfa (activated) in adults with severe sepsis: Comparison with a controlled clinical trial. Crit Care Med 2008; 36:14-23
    • (2008) Crit Care Med , vol.36 , pp. 14-23
    • Wheeler, A.1    Steingrub, J.2    Schmidt, G.A.3
  • 11
    • 25444492831 scopus 로고    scopus 로고
    • Drotrecogin alfa (activated) for adults with severe sepsis and a low risk of death
    • Abraham E, Laterre PF, Garg R, et al: Drotrecogin alfa (activated) for adults with severe sepsis and a low risk of death. N Engl J Med 2005; 353:1332-1341
    • (2005) N Engl J Med , vol.353 , pp. 1332-1341
    • Abraham, E.1    Laterre, P.F.2    Garg, R.3
  • 12
    • 26444604781 scopus 로고    scopus 로고
    • Dro-trecogin alfa (activated) treatment in severe sepsis from the global open-label trial ENHANCE: Further evidence for survival and safety and implications for early treatment
    • Vincent JL, Bernard GR, Beale R, et al: Dro-trecogin alfa (activated) treatment in severe sepsis from the global open-label trial ENHANCE: Further evidence for survival and safety and implications for early treatment. Crit Care Med 2005, 33:2266-2277
    • (2005) Crit Care Med , vol.33 , pp. 2266-2277
    • Vincent, J.L.1    Bernard, G.R.2    Beale, R.3
  • 13
    • 67650349184 scopus 로고    scopus 로고
    • Guidance for Industry: Warnings and Pre- cautions, Contraindications, and Boxed Warning Sections of Labeling for Human Prescription Drug and Biological Products - Content and Format. Available at: http:// www.fda.gov/cber/gdlns/ boxwarlb.htm. Accessed November 20, 2008
    • Guidance for Industry: Warnings and Pre- cautions, Contraindications, and Boxed Warning Sections of Labeling for Human Prescription Drug and Biological Products - Content and Format. Available at: http:// www.fda.gov/cber/gdlns/ boxwarlb.htm. Accessed November 20, 2008
  • 14
    • 33847687731 scopus 로고    scopus 로고
    • Drotrecogin alfa (activated) in children with severe sepsis: A multicentre phase III randomised controlled trial
    • Nadel S, Goldstein B, Williams MD, et al: Drotrecogin alfa (activated) in children with severe sepsis: A multicentre phase III randomised controlled trial. Lancet 2007; 369:836-843
    • (2007) Lancet , vol.369 , pp. 836-843
    • Nadel, S.1    Goldstein, B.2    Williams, M.D.3
  • 15
    • 30044435348 scopus 로고    scopus 로고
    • Friedrich JO, LaRosa SP, Baillie JK, et al: Drotrecogin alfa (activated) in severe sepsis. N Engl J Med 2006; 354:94-96 16. National Library of Medicine: Efficacy and safety of drotrecogin alfa (activated) in adult patients with septic shock. In: ClinicalTrials. gov [Internet]. Bethesda (MD), National Library of Medicine (US), 2000-2008. Available at: http:// clinicaltrials.gov/ct2/show/ NCT00604214?term=sepsis+xigris&rank=7 NLM. Identifier: NCT00604214. Accessed November 20, 2008
    • Friedrich JO, LaRosa SP, Baillie JK, et al: Drotrecogin alfa (activated) in severe sepsis. N Engl J Med 2006; 354:94-96 16. National Library of Medicine: Efficacy and safety of drotrecogin alfa (activated) in adult patients with septic shock. In: ClinicalTrials. gov [Internet]. Bethesda (MD), National Library of Medicine (US), 2000-2008. Available at: http:// clinicaltrials.gov/ct2/show/ NCT00604214?term=sepsis+xigris&rank=7 NLM. Identifier: NCT00604214. Accessed November 20, 2008


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.