메뉴 건너뛰기




Volumn 42, Issue 3, 2012, Pages 252-259

Pharmacokinetics and safety of Intragam 10 NF, the next generation 10% liquid intravenous immunoglobulin, in patients with primary antibody deficiencies

Author keywords

Agammaglobulinaemia; Antibody deficiency syndrome; Immunoglobulin; Intragam 10 NF; Pharmacokinetics

Indexed keywords

IMMUNOGLOBULIN; IMMUNOGLOBULIN G;

EID: 84858728731     PISSN: 14440903     EISSN: 14455994     Source Type: Journal    
DOI: 10.1111/j.1445-5994.2011.02712.x     Document Type: Article
Times cited : (7)

References (29)
  • 2
    • 71249150816 scopus 로고    scopus 로고
    • The use of immunoglobulin therapy for patients with primary immune deficiency: an evidence-based practice guideline
    • Shehata N. The use of immunoglobulin therapy for patients with primary immune deficiency: an evidence-based practice guideline. Transfus Med Rev 2010; 24 (Suppl 1): 28-50.
    • (2010) Transfus Med Rev , vol.24 , Issue.1 SUPPL. , pp. 28-50
    • Shehata, N.1
  • 3
    • 33645341439 scopus 로고    scopus 로고
    • Use of intravenous immunoglobulin in human disease: a review of evidence by members of the Primary Immunodeficiency Committee of the American Academy of Allergy, Asthma and Immunology
    • Orange JS, Hossny EM, Weiler CR, Ballow M, Berger M, Bonilla FA etal. Use of intravenous immunoglobulin in human disease: a review of evidence by members of the Primary Immunodeficiency Committee of the American Academy of Allergy, Asthma and Immunology. J Allergy Clin Immunol 2006; 117 (Suppl 4): S525-53.
    • (2006) J Allergy Clin Immunol , vol.117 , Issue.4 SUPPL.
    • Orange, J.S.1    Hossny, E.M.2    Weiler, C.R.3    Ballow, M.4    Berger, M.5    Bonilla, F.A.6
  • 4
    • 73649119908 scopus 로고    scopus 로고
    • Intravenous immunoglobulin G: trends in production methods, quality control and quality assurance
    • Radosevich M, Burnouf T. Intravenous immunoglobulin G: trends in production methods, quality control and quality assurance. Vox Sang 2010; 98: 12-28.
    • (2010) Vox Sang , vol.98 , pp. 12-28
    • Radosevich, M.1    Burnouf, T.2
  • 5
    • 84858735528 scopus 로고    scopus 로고
    • ® P. Australian approved product information. [cited 2011 October 31] CSL Limited. Available from URL:
    • ® P. Australian approved product information. 2007 [cited 2011 October 31] CSL Limited. Available from URL:.
    • (2007)
  • 6
    • 84858726139 scopus 로고    scopus 로고
    • Pathogen safety of immunoglobulin preparations
    • Wahn V, Orange J, eds. Bremen: Uni-Med Science
    • Spaeth P, Van Holten RW. Pathogen safety of immunoglobulin preparations. In: Wahn V, Orange J, eds. Clinical Use of Immunoglobulins. Bremen: Uni-Med Science; 2008; 40.
    • (2008) Clinical Use of Immunoglobulins , pp. 40
    • Spaeth, P.1    Van Holten, R.W.2
  • 7
    • 33750875035 scopus 로고    scopus 로고
    • Chromatographic purification of immunoglobulins
    • Bertolini J. Chromatographic purification of immunoglobulins. Downstream 1999; 31: 20-1.
    • (1999) Downstream , vol.31 , pp. 20-21
    • Bertolini, J.1
  • 8
    • 0034488375 scopus 로고    scopus 로고
    • The use of chromatography to manufacture purer and safer plasma products
    • Johnston A, Adcock W. The use of chromatography to manufacture purer and safer plasma products. Biotechnol Genet Eng Rev 2000; 17: 37-70.
    • (2000) Biotechnol Genet Eng Rev , vol.17 , pp. 37-70
    • Johnston, A.1    Adcock, W.2
  • 9
    • 84858726138 scopus 로고    scopus 로고
    • ® 10 NF. Australian approved product information. [cited 2011 October 31] CSL Limited. Available from URL:
    • ® 10 NF. Australian approved product information. 2011 [cited 2011 October 31] CSL Limited. Available from URL:.
    • (2011)
  • 10
  • 13
    • 33846700716 scopus 로고    scopus 로고
    • Current strategies to prevent transmission of prions by human plasma derivatives
    • Burnouf T, Padilla A. Current strategies to prevent transmission of prions by human plasma derivatives. Transfus Clin Biol 2006; 13: 320-8.
    • (2006) Transfus Clin Biol , vol.13 , pp. 320-328
    • Burnouf, T.1    Padilla, A.2
  • 14
    • 84858726140 scopus 로고    scopus 로고
    • The European Agency for the Evaluation of Medicinal Products, Committee for Proprietary Medicinal Products (CPMP). Note for guidance on the clinical investigation of human normal immunoglobulin for intravenous administration (IVIg). CPMP/BPWG/388/95 rev.1; June [cited 2010 June 23] Available from:
    • The European Agency for the Evaluation of Medicinal Products, Committee for Proprietary Medicinal Products (CPMP). Note for guidance on the clinical investigation of human normal immunoglobulin for intravenous administration (IVIg). CPMP/BPWG/388/95 rev.1; June 2000. [cited 2010 June 23] Available from:.
    • (2000)
  • 15
    • 67349234104 scopus 로고    scopus 로고
    • Pharmacokinetics of a new 10% intravenous immunoglobulin in patients receiving replacement therapy for primary immunodeficiency
    • Wasserman RL, Church JA, Peter HA, Sleasman JW, Melamed I, Stein MR etal. Pharmacokinetics of a new 10% intravenous immunoglobulin in patients receiving replacement therapy for primary immunodeficiency. Eur J Pharm Sci 2009; 37: 272-8.
    • (2009) Eur J Pharm Sci , vol.37 , pp. 272-278
    • Wasserman, R.L.1    Church, J.A.2    Peter, H.A.3    Sleasman, J.W.4    Melamed, I.5    Stein, M.R.6
  • 17
    • 10744230553 scopus 로고    scopus 로고
    • Efficacy, tolerability, safety and pharmacokinetics of a nanofiltered intravenous immunoglobulin: studies in patients with immune thrombocytopenic purpura and primary immunodeficiencies
    • Wolf HH, Davies SV, Borte M, Caulier MT, Williams PE, Bernuth HV etal. Efficacy, tolerability, safety and pharmacokinetics of a nanofiltered intravenous immunoglobulin: studies in patients with immune thrombocytopenic purpura and primary immunodeficiencies. Vox Sang 2003; 84: 45-53.
    • (2003) Vox Sang , vol.84 , pp. 45-53
    • Wolf, H.H.1    Davies, S.V.2    Borte, M.3    Caulier, M.T.4    Williams, P.E.5    Bernuth, H.V.6
  • 18
    • 3543141237 scopus 로고    scopus 로고
    • ® 5%, an intravenous IgG product, is efficacious and well tolerated in subjects with primary immunodeficiency diseases
    • The Octagam Study Group.
    • ® 5%, an intravenous IgG product, is efficacious and well tolerated in subjects with primary immunodeficiency diseases. J Clin Immunol 2004; 24: 309-14.
    • (2004) J Clin Immunol , vol.24 , pp. 309-314
    • Ochs, H.D.1    Pinciaro, P.J.2
  • 19
    • 4444298209 scopus 로고    scopus 로고
    • Clinical properties of a novel liquid intravenous immunoglobulin: studies in patients with immune thrombocytopenic purpura and primary immunodeficiencies
    • Borte M, Davies SV, Touraine JL, Farber CM, Lipsic T, Adams C etal. Clinical properties of a novel liquid intravenous immunoglobulin: studies in patients with immune thrombocytopenic purpura and primary immunodeficiencies. Transfus Med Hemother 2004; 31: 126-34.
    • (2004) Transfus Med Hemother , vol.31 , pp. 126-134
    • Borte, M.1    Davies, S.V.2    Touraine, J.L.3    Farber, C.M.4    Lipsic, T.5    Adams, C.6
  • 20
    • 3442901469 scopus 로고    scopus 로고
    • ® 5% [immune globulin intravenous (human)] for replacement therapy in primary immunodeficiency diseases
    • ® 5% investigators.
    • ® 5% [immune globulin intravenous (human)] for replacement therapy in primary immunodeficiency diseases. J Clin Immunol 2004; 24: 389-96.
    • (2004) J Clin Immunol , vol.24 , pp. 389-396
    • Berger, M.1    Pinciaro, P.J.2
  • 21
    • 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 Gracia J, Hernández F, Pons J, Álvarez A, Jiménez V. A prospective controlled crossover trial of a new presentation (10% vs 5%) of a heat-treated intravenous immunoglobulin. Int Immunopharmacol 2005; 5: 619-26.
    • (2005) Int Immunopharmacol , vol.5 , pp. 619-626
    • Matamoros, N.1    De Gracia, J.2    Hernández, F.3    Pons, J.4    Álvarez, A.5    Jiménez, V.6
  • 22
    • 33745877615 scopus 로고    scopus 로고
    • Efficacy, safety and tolerability of a new 10% liquid intravenous immune globulin [IGIV 10%] in patients with primary immunodeficiency diseases
    • Church JA, Leibl H, Stein MR, Melamed IR, Rubinstein A, Schneider LC etal. Efficacy, safety and tolerability of a new 10% liquid intravenous immune globulin [IGIV 10%] in patients with primary immunodeficiency diseases. J Clin Immunol 2006; 26: 388-95.
    • (2006) J Clin Immunol , vol.26 , pp. 388-395
    • Church, J.A.1    Leibl, H.2    Stein, M.R.3    Melamed, I.R.4    Rubinstein, A.5    Schneider, L.C.6
  • 24
    • 33744498618 scopus 로고    scopus 로고
    • Pharmacokinetics of intravenous immunoglobulin: a systematic review
    • Koleba T, Ensom MH. Pharmacokinetics of intravenous immunoglobulin: a systematic review. Pharmacotherapy 2006; 26: 813-27.
    • (2006) Pharmacotherapy , vol.26 , pp. 813-827
    • Koleba, T.1    Ensom, M.H.2
  • 25
    • 53849119869 scopus 로고    scopus 로고
    • Pharmacokinetics of immunoglobulin administered via intravenous or subcutaneous routes
    • Bonilla FA. Pharmacokinetics of immunoglobulin administered via intravenous or subcutaneous routes. Immunol Allergy Clin North Am 2008; 28: 803-19.
    • (2008) Immunol Allergy Clin North Am , vol.28 , pp. 803-819
    • Bonilla, F.A.1
  • 26
    • 77956615735 scopus 로고    scopus 로고
    • Impact of trough IgG on pneumonia incidence in primary immunodeficiency: a meta-analysis of clinical studies
    • Orange J. Impact of trough IgG on pneumonia incidence in primary immunodeficiency: a meta-analysis of clinical studies. Clin Immunol 2010; 137: 21-30.
    • (2010) Clin Immunol , vol.137 , pp. 21-30
    • Orange, J.1
  • 27
    • 77952741985 scopus 로고    scopus 로고
    • Infection outcomes in patients with common variable immunodeficiency disorders: relationship to immunoglobulin therapy over 22years
    • Lucas M, Lee M, Lortan J, Lopez-Granados E, Misbah S, Chapel H. Infection outcomes in patients with common variable immunodeficiency disorders: relationship to immunoglobulin therapy over 22years. J Allergy Clin Immunol 2010; 125: 1354-60.
    • (2010) J Allergy Clin Immunol , vol.125 , pp. 1354-1360
    • Lucas, M.1    Lee, M.2    Lortan, J.3    Lopez-Granados, E.4    Misbah, S.5    Chapel, H.6
  • 28
    • 79961169935 scopus 로고    scopus 로고
    • Effectiveness of immunoglobulin replacement therapy on clinical outcome in patients with primary antibody deficiencies: results from a multicenter prospective cohort study
    • Quinti I, Soresina A, Guerra A, Rondelli R, Spadaro G, Agostini C etal. Effectiveness of immunoglobulin replacement therapy on clinical outcome in patients with primary antibody deficiencies: results from a multicenter prospective cohort study. J Clin Immunol 2011; 31: 315-22.
    • (2011) J Clin Immunol , vol.31 , pp. 315-322
    • Quinti, I.1    Soresina, A.2    Guerra, A.3    Rondelli, R.4    Spadaro, G.5    Agostini, C.6
  • 29
    • 80052539258 scopus 로고    scopus 로고
    • Comparison of intravenous immunoglobulin formulations: product, formulary, and cost considerations
    • Scott M. Comparison of intravenous immunoglobulin formulations: product, formulary, and cost considerations. Hosp Pharm 2011; 46: 668-76.
    • (2011) Hosp Pharm , vol.46 , pp. 668-676
    • Scott, M.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.