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Volumn 57, Issue 7, 2013, Pages 527-535

Post-marketing observational study on 5% intravenous immunoglobulin therapy in patients with secondary immunodeficiency and recurrent serious bacterial infections

Author keywords

Chronic lymphocytic leukemia; Intravenous immunoglobulin; Recurrent infections; Secondary immunodeficiency

Indexed keywords

IMMUNOGLOBULIN;

EID: 84880404637     PISSN: 03855600     EISSN: 13480421     Source Type: Journal    
DOI: 10.1111/1348-0421.12060     Document Type: Article
Times cited : (23)

References (28)
  • 4
    • 66649100502 scopus 로고    scopus 로고
    • Targeting DNA repair in chronic lymphocytic leukemia cells with a novel acyclic nucleotide analogue, GS-9219
    • Tsai C.Y., Ray A.S., Tumas D.B., Keating M.J., Reiser H., Plunkett W. (2009) Targeting DNA repair in chronic lymphocytic leukemia cells with a novel acyclic nucleotide analogue, GS-9219. Clin Cancer Res 15: 3760-3769.
    • (2009) Clin Cancer Res , vol.15 , pp. 3760-3769
    • Tsai, C.Y.1    Ray, A.S.2    Tumas, D.B.3    Keating, M.J.4    Reiser, H.5    Plunkett, W.6
  • 5
    • 0016740933 scopus 로고
    • Clinical staging of chronic lymphocytic leukemia
    • Rai K.R. (1975) Clinical staging of chronic lymphocytic leukemia. Blood 46: 219-234.
    • (1975) Blood , vol.46 , pp. 219-234
    • Rai, K.R.1
  • 7
    • 0028136984 scopus 로고
    • Treatment of hypogammaglobulinaemia in chronic lymphocytic leukaemia by low-dose intravenous gammaglobulin
    • Jurlander J., Geisler C.H., Hansen M.M. (1994) Treatment of hypogammaglobulinaemia in chronic lymphocytic leukaemia by low-dose intravenous gammaglobulin. Eur J Haematol 53: 114-118.
    • (1994) Eur J Haematol , vol.53 , pp. 114-118
    • Jurlander, J.1    Geisler, C.H.2    Hansen, M.M.3
  • 8
    • 84880432762 scopus 로고    scopus 로고
    • The European Agency for the Evaluation of Medicinal Products. Guideline on core SmPC for human normal immunoglobulin for intravenous administration (IVIg) (EMA/CHMP/BPWP/94038/2007 rev. 3).
    • The European Agency for the Evaluation of Medicinal Products. (2010) Guideline on core SmPC for human normal immunoglobulin for intravenous administration (IVIg) (EMA/CHMP/BPWP/94038/2007 rev. 3).
    • (2010)
  • 9
    • 0021271330 scopus 로고
    • Use of intravenous immunoglobulin in chronic lymphocytic leukemia
    • Besa E.C. (1984) Use of intravenous immunoglobulin in chronic lymphocytic leukemia. Am J Med 76: 209-218.
    • (1984) Am J Med , vol.76 , pp. 209-218
    • Besa, E.C.1
  • 10
    • 0023764718 scopus 로고
    • Intravenous immunoglobulin for the prevention of infection in chronic lymphocytic leukemia. A randomized, controlled clinical trial
    • Cooperative Group for the Study of Immunoglobulin in Chronic Lymphocytic Leukemia
    • Cooperative Group for the Study of Immunoglobulin in Chronic Lymphocytic Leukemia. (1988) Intravenous immunoglobulin for the prevention of infection in chronic lymphocytic leukemia. A randomized, controlled clinical trial. N Engl J Med 319: 902-907.
    • (1988) N Engl J Med , vol.319 , pp. 902-907
  • 11
    • 84880443348 scopus 로고
    • Efficacy and safety of pasteurized intravenous 7S-immunoglobulin in primary and secondary immune deficiencies: results of a multicenter trial. 12th European Immunology Meeting Barcelona Abstract W50-15
    • Ehninger G., Jopski B., Dopfer R., Wahn U., Grehen J., Zurborn K.H., (1994) Efficacy and safety of pasteurized intravenous 7S-immunoglobulin in primary and secondary immune deficiencies: results of a multicenter trial. 12th European Immunology Meeting Barcelona Abstract W50-15: 457.
    • (1994) , pp. 457
    • Ehninger, G.1    Jopski, B.2    Dopfer, R.3    Wahn, U.4    Grehen, J.5    Zurborn, K.H.6
  • 12
    • 0028900585 scopus 로고
    • Randomized trial of intravenous immunoglobulin prophylaxis for patients with chronic lymphocytic leukaemia and secondary hypogammaglobulinaemia
    • Boughton B., Jackson N., Lim S., Smith N. (1995) Randomized trial of intravenous immunoglobulin prophylaxis for patients with chronic lymphocytic leukaemia and secondary hypogammaglobulinaemia. Clin Lab Haem 17: 75-780.
    • (1995) Clin Lab Haem , vol.17 , pp. 75-780
    • Boughton, B.1    Jackson, N.2    Lim, S.3    Smith, N.4
  • 13
    • 0026512263 scopus 로고
    • Immunoglobulin replacement in patients with chronic lymphocytic leukemia (CLL): kinetics of immunoglobulin metabolism
    • Chapel H.M., Lee M. (1992) Immunoglobulin replacement in patients with chronic lymphocytic leukemia (CLL): kinetics of immunoglobulin metabolism. J Clin Immunol 12: 17-20.
    • (1992) J Clin Immunol , vol.12 , pp. 17-20
    • Chapel, H.M.1    Lee, M.2
  • 17
    • 0016804136 scopus 로고
    • A clinical staging system for multiple myeloma. Correlation of measured myeloma cell mass with presenting clinical features, response to treatment, and survival
    • Durie B.G., Salmon S.E. (1975) A clinical staging system for multiple myeloma. Correlation of measured myeloma cell mass with presenting clinical features, response to treatment, and survival. Cancer 36: 842-854.
    • (1975) Cancer , vol.36 , pp. 842-854
    • Durie, B.G.1    Salmon, S.E.2
  • 18
    • 45149100665 scopus 로고    scopus 로고
    • Guidelines for the diagnosis and treatment of chronic lymphocytic leukemia: a report from the International Workshop on Chronic Lymphocytic Leukemia updating the National Cancer Institute-Working Group 1996 guidelines
    • Hallek M., Cheson B.D., Catovsky D., Caligaris-Cappio F., Dighiero G., Dohner H., Hillmen P., Keating M.J., Montserrat E., Rai K.R., Kipps T.J. (2008) Guidelines for the diagnosis and treatment of chronic lymphocytic leukemia: a report from the International Workshop on Chronic Lymphocytic Leukemia updating the National Cancer Institute-Working Group 1996 guidelines. Blood 111: 5446-5456.
    • (2008) Blood , vol.111 , pp. 5446-5456
    • Hallek, M.1    Cheson, B.D.2    Catovsky, D.3    Caligaris-Cappio, F.4    Dighiero, G.5    Dohner, H.6    Hillmen, P.7    Keating, M.J.8    Montserrat, E.9    Rai, K.R.10    Kipps, T.J.11
  • 19
    • 84880400511 scopus 로고    scopus 로고
    • Instituto Grifols S.A. Flebogamma 5%: Summary of product characteristics available at Last accessed: October 29
    • Instituto Grifols S.A. Flebogamma 5%: Summary of product characteristics available at http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000781/WC500023473.pdf. Last accessed: October 29, 2012.
    • (2012)
  • 20
    • 84880410735 scopus 로고    scopus 로고
    • The European Agency for the Evaluation of Medicinal Products. Notice to Marketing Authorisation Holders. Pharmacovigilance Guidelines. CPMP/PhVWP/108/99
    • The European Agency for the Evaluation of Medicinal Products. (1999) Notice to Marketing Authorisation Holders. Pharmacovigilance Guidelines. CPMP/PhVWP/108/99.
    • (1999)
  • 21
    • 84957027139 scopus 로고    scopus 로고
    • Cologne, Germany: Gerd Herold, Lulu. com
    • Herold G. (2010). Internal Medicine. Cologne, Germany: Gerd Herold, Lulu. com.
    • (2010) Internal Medicine
    • Herold, G.1
  • 22
    • 4744361075 scopus 로고
    • Case records of the Massachusetts General Hospital. Weekly clinicopathological exercises. Laboratory reference values
    • Kratz A., Ferraro M., Sluss P.M., Lewandrowski K.B. (1993) Case records of the Massachusetts General Hospital. Weekly clinicopathological exercises. Laboratory reference values. N Engl J Med 351: 1548-63.
    • (1993) N Engl J Med , vol.351 , pp. 1548-1563
    • Kratz, A.1    Ferraro, M.2    Sluss, P.M.3    Lewandrowski, K.B.4
  • 23
  • 24
    • 15944416175 scopus 로고    scopus 로고
    • A prospective controlled crossover trial of a new presentation (10% vs. 5%) of a heat-treated intravenous immunoglobulin
    • Matamoros N., De Gracis J., Hernandez F., Pons J., Alvarez A., Jimenez V. (2005) A prospective controlled crossover trial of a new presentation (10% vs. 5%) of a heat-treated intravenous immunoglobulin. Int Immunopharmacol 5: 619-626.
    • (2005) Int Immunopharmacol , vol.5 , pp. 619-626
    • Matamoros, N.1    De Gracis, J.2    Hernandez, F.3    Pons, J.4    Alvarez, A.5    Jimenez, V.6
  • 25
    • 33748755368 scopus 로고    scopus 로고
    • High incidence of non-neutropenic infections induced by rituximab plus fludarabine and associated with hypogammaglobulinemia: a frequently unrecognized and easily treatable complication
    • Cabanillas F., Liboy I., Pavia O., Rivera E. (2006) High incidence of non-neutropenic infections induced by rituximab plus fludarabine and associated with hypogammaglobulinemia: a frequently unrecognized and easily treatable complication. Ann Oncol 17: 1424-1427.
    • (2006) Ann Oncol , vol.17 , pp. 1424-1427
    • Cabanillas, F.1    Liboy, I.2    Pavia, O.3    Rivera, E.4
  • 26
    • 84880447645 scopus 로고    scopus 로고
    • US FDA. Guidance for Industry. Efficacy and pharmacokinetic studies to support marketing of immune globulin intravenous (human) as replacement therapy for primary immune deficiency. Last accessed: October 29, FDA 29-6-0008; Available from URL:
    • US FDA. Guidance for Industry. Efficacy and pharmacokinetic studies to support marketing of immune globulin intravenous (human) as replacement therapy for primary immune deficiency. Last accessed: October 29, 2012. FDA 29-6-0008; Available from URL: http://www.fda.gov/downloads/biologicsbloodvaccines/guidancecomplianceregulatoryinformation/guidances/blood/ucm078526.pdf.
    • (2012)
  • 27
    • 53649100150 scopus 로고    scopus 로고
    • Intravenous immunoglobulins: evolution of commercial IVIG preparations
    • Hooper J.A. (2008) Intravenous immunoglobulins: evolution of commercial IVIG preparations. Immunol Allergy Clin North Am 28: 765-778 viii.
    • (2008) Immunol Allergy Clin North Am , vol.28
    • Hooper, J.A.1
  • 28
    • 3442901469 scopus 로고    scopus 로고
    • Safety, efficacy, and pharmacokinetics of Flebogamma 5% [immune globulin intravenous (human)] for replacement therapy in primary immunodeficiency diseases
    • Berger M., Pinciaro P.J. (2004) Safety, efficacy, and pharmacokinetics of Flebogamma 5% [immune globulin intravenous (human)] for replacement therapy in primary immunodeficiency diseases. J Clin Immunol 24: 389-396.
    • (2004) J Clin Immunol , vol.24 , pp. 389-396
    • Berger, M.1    Pinciaro, P.J.2


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.