5%免疫球蛋白靜脈注射液

5% 免疫球蛋白靜脈注射液 Immune Globulin lntravenous (Human) 5% Gamimune N 5% Solvent/Detergent Treated 衛署菌疫輸字第 000215 號性狀 / 理 5% -Gamimune N 5% 4.5-5.5% 9-11% 糖不 50 98% (gamma globulin)90%(igg) IgA IgM IgG (subclasses) Gamimune N 5% 力 16.5 量 0.33 量 309 milliosmoles 278 milliosmoles 量冷精濾濾 Cohn Effluent III 離來 0.3% (Tri-n-butyl phosphate, TNBP) 0.2%(TNBP) 30 度不 6 濾濾濾 ph 4.0-4.5 1 糖 ph 4.25 20 21 Gamimune N 5% 類 (HIV-1) 痢 (BVDV) C (PRV) B 李 (Reo) 理 Fraction II + III W Effluent III Effluent III Filtrate III 見 TNBP/ 理 Filtrate III ph 臨床藥理學不 Gamimune N 5% 理 IgG 來 Gamimune N 5% 100%IgG 立 2 ph6.8 IgG 24 30%IgG 2-5 IgG 度降度 40% 2-5 Gamimune N 5% IgG 異異量率 Gamimune N 5% 16 行 (ITP) Gamimune N 5%(ITP) 例 ( 見 ) 20 100 列 Gamimune N 5% (AGVHD) 6 見 IgG IgG 量 Gamimune N 5% IgG IgG 量 Gamimune N 5% 降 AGVHD 率 (HIV) 7-10 HIV 11-13 71 HIV 3.5 年 27 (37%) 12 HIV 類 (hypogammaglobulinemia) 14 IgG HIV 15-16 1988 年 3 7 1991 年 1 15 - 療 Gamimune N 5% 降 HIV 度率見例療臨 1990 年 12 數 Gamimune N 5%CD4+ 200/mm 3 HIV 料 (DSMB) 糖 17-21 良 0.25 率不良 18 行 10% 糖 0.27~0.62 21 不良 2 糖糖尿糖糖量利尿 2

良不良 2 率 0.08 參量 0.48 糖 Gamimune N 5% 力 16.5 量 / 0.33 量 / 1000 / 0.33 量 / 力 45~50 量 / 3.6 量 / 22 Gamimune N 5% 量 1000 / 來力來量 Gamimune N 5% 量 150 / 不 ph 2 37 Gamimune N 5% 量 400 / ph6.8 來 ph 臨異 2 Gamimune N 5% 適應症不 HIV 說不 Gamimune N 5% 療力不狀不 Wiskott-Aldrich IgMX-linked 不不 5, 23-25 度列 Gamimune N 5% (ITP) 數來 ITP 行 Gamimune N 5% 1~5 不數 ITP 療臨 Gamimune N 5% 兩不量 400 / 連量療 1000 / 連 Gamimune N 5% 臨六 (83.3%) 16 12 (75%)ITP 400 / 連臨 30,000/mm 3 ITP 數 27,900/mm 3 297,000/mm 3 50,000-455,000/mm 3 ITP 數 27,900/mm 3 124,900/mm 3 11,000-341,000/mm 3 ITP 復 ITP 14 13 (92.9%) 29 26 (89.7%) Gamimune N 5% 1000 / 連療臨 30,000/mm 3 ITP 不 (HIV)ITPGamimune N 5% 1000 / 連 ITP 數 44,400/mm 3 285,600/mm 3 89,000-473,000/mm 3 ITP 數 23,400/mm 3 173,100/mm 3 28,000-709,000/mm 3 ITP ITP 療復 29 ITP 六切 Gamimune N 5% 1000 / 連數數 14,500/mm 3 129,300/mm 3 51,000-242,000/mm 3 Gamimune N 5% 量來療 ITP 不數 12 更 ITP 量 Gamimune N 5% 400-1000 / 數來 (BMT) Gamimune N 5% 20 100 (AGVHD) Gamimune N 5% 不 20 369 185 Gamimune N 5% 療療 184 7 2 Gamimune N 5% 500 / 90 20 < 20 20 128 療 119 100 21% 療 9% (P=0.0032) 降率降 128 53 療 119 26 療 [RR] 2.36, P=0.0025 G( ) 128 24 療 119 9 (RR2.53, P=0.015) G( ) 128 16 療 119 8 (RR2.73, P=0.046) AGVHD 率 110 58 療 108 38 (P=0.0051) P (multiple endpoints) (subset analyses) P 率 (chance) 率 20 Gamimune N 5% 療降 AGVHD 率不 28 Gamimune N 5% 400 / 降臨率 Gamimune N 5% Streptococcus pneumoniae bacteremia 行 394 13

HIV 369 列 376 列 (1) 年 40 2.4-136.8 (2) HIV (91%) (3) CDC class P-2 (87%) (4) CD4+ 數 937 cells / mm 3 ( 0-6660 cells/mm 3 ) 14% ( 52/369 ) Pneumocystis carinii pneumonia (PCP) 療 51% (189/369) PCP 療 44% (164/369) zidovudine (ZDV) 療 CD4+ ( 200 cells/mm 3 vs 200 cells/mm 3 )HIV CDC 類 [P-2-D-1] [P-2-D-2] vshiv-1 28 Gamimune N 5% (400mg/kg=8ml/kg) (n=185) 量 (0.1% Albumin (Human) ) (n=184)gamimune N 5% 17.9 17.8 47% (86/184)Gamimune N 5% 30% (55/185) (P=0.0009)P (two-sided)gamimune N 5% 療 36/184 18/185 P=0.0081 臨 71/184 45/185 P=0.0036 CD4+ <200/mm 3 類數 DSMB 料不療 / 年率兩年療 Gamimune N 5% 療 50.5% / 年 9.1 18.2 P=0.031 臨率 36.0% / 年 24.0 37.5 P=0.0130 臨 40.6% / 年 33.1 55.7 P=0.003 率 60% / 年 5.8 14.5 P= 0.009 Streptococcus pneumoniae 率 75.6%/ 年 1.1 4.5 P=0.026 臨率 54.3%12.7 27.8 P=0.001 度率 22.5% / 年 123.6 159.5 P=0.033 了率 Gamimune N 5% 數 / 年 36.8% 72 114 / 年 P=0.002 數 6.9 10.5/ 年 P=0.030 24 Gamimune N 5% 率 (P=0.0093) 臨率 (P=0.0015) 24 Gamimune N 5% 87.8% 76.1% 臨率 63.5% 44.5% 率 (17%) Gamimune N 5% 療不率率療降率 PCP 療 Gamimune N 5%PCP 療 (96%) 連 3 trimethoprim/sulfamethoxazole 類見 PCP 療 Gamimune N 5% 44.0 / 年 64.7 / 年 (P=0.047) PCP 療 Gamimune N 5% 22.1 / 年 / 年 44.9 (P=0.024) 不 PCP 療 Gamimune N 5% 都利率 PCP 療禁忌 5% -Gamimune N 5% 類 IgA IgA 不 Gamimune N 5% IgA 23 警語本製劑由人類血漿製成, 凡是由人類血漿製成的產品可能含有如病毒等感染物質而致病可藉由下列方式減低此類製劑傳染感染物質的危險, 如篩選血漿提供者之前是否曾暴露於某些特定病毒檢測是否有被已知的特定病毒感染及去活化和 / 或移除特定病毒雖然如此方式檢測, 此類製劑仍有傳染病毒的潛在可能, 因目前仍有未知的感染物質可能存在血漿製劑有些輸血或使用血漿製劑的個案, 可能會產生一些病毒感染的訊息和 / 或症狀, 特別是 C 型肝炎所有醫師認為可能由本製劑所傳染造成的感染, 醫師或其他醫護人員都必須回報至台灣拜耳股份有限公司西藥處 ( 電話 :25039123) 醫師須在處方或使用本製劑前先與病患討論使用本製劑的風險與益處因為肌肉和皮下注射尚未作評估,Gamimune N 5% 僅能做靜脈注射即使病人不知對免疫球蛋白製劑敏感, 很罕見情況下,Gamimune N 5% 可能造成血壓急速降低和過敏性反應的臨床症狀這些反應可能與輸注速率有關因此, 應小心遵照 ( 劑量和用法 ) 中提到的輸注速率, 至少醫師對病人有足夠的了解前要特別注意於整個輸注過程中應該持續地監視病人, 且仔細觀察任何徵候應預備腎上腺素來治療急性過敏性反應注意事項一般事項本製劑於開封後應立即使用, 未用完之小瓶應予丟棄, 藥液混濁或曾經結凍則不可使用曾有報告指出少數接受人血免疫球蛋白治療的人會產生無菌性腦膜炎徵候群 (AMS), 此種徵候群通常發生於使用人血免疫球蛋白後的數小時至二天內發生其症狀包括嚴重的頭痛頸背僵硬嗜睡發燒畏光眼睛運動疼痛噁心及嘔吐腦脊髓液研究呈陽性反應, 腦脊髓液內細胞增多至每 mm 3 數千個細胞, 顆粒性細胞系顯著增多, 及蛋白質的量亦上升至每 dl 數百毫克產生這種徵候及症兆的病人, 應該接受完整的神經學檢驗, 包括 CSF 檢驗以排除其他腦膜炎的原因接受高劑量 (2g/kg) 人血免疫球蛋白治療的病人發生 AMS 的頻率較高, 停止人血免疫球蛋白的治療幾天內可以減輕 AMS, 且無後遺症 26-29

投予免疫球蛋白靜脈注射液 ( 人類 ) 治療後, 曾有零星報告出現短暫性與可逆性腎功能不全, 30,31 相關機轉尚未確定藥物交互作用本製劑中之抗體可能會干擾麻疹, 腮腺炎或德國麻疹等活病毒疫苗之反應因此上述疫苗應於使用本製劑大約六個月後再接種請參閱 ( 劑量與用法 ) 中之其他藥物交互作用懷孕類別 C 尚未進行動物生殖研究, 也未知本品投予孕婦時是否傷害胎兒或是否影響生育能力, 僅於有明確需求時方可投予孕婦不良反應不 37 不 Gamimune N 5% 400 / 5.2% 不冷例 Gamimune N 5% 16 年行 Gamimune N 5%/ 理 Gamimune N 5% 率度 Gamimune N 5% 異 (ITP) Gamimune N 5% 400 / 來療 ITP 154 4 (2.6%) 率 0.04 / 84 / Gamimune N 5% 1000 / 量連來療 ITP 251 25 (10%) 冷量率良率 0.06 / 不良率 Gamimune N 5% 不良度降率 185 7 2 90 Gamimune N 5% 500 /(10ml/kg) 185 12 (6.5%) 2176 14 (0.6%) 不良不良都率見冷不不良都不療降率 376 187 Gamimune N 5% 療 189 (0.1%, Albumin(Human)) 列 Gamimune N 5% 3451 50 (1.4%) 24 不良 3447 62 (1.8%) 見不良 105 30 (28.6%) 療 78 19 (24.4%) 見不良 105 10 (9.5%) 療 78 9 (11.5%) 不良兩不良數不良 Gamimune N 5% 療理 Gamimune N 5% 行 Gamimune N 5% 類 Gamimune N 5% 不良暈見率 Gamimune N 5% 歷不良 2,32 見 2 劑量與用法量見列 Gamimune N 5% 0.01-0.02ml/ 率 30 良率 0.08ml / Gamimune N 5% 率良若降率率粒若 Gamimune N 5%Gamimune N 5% Gamimune N 5% 若 5% 糖 (D5/W) 不 Gamimune N 5% 不量 100-200 / 2-4 / 臨不 IgG 量不數量 400 /8 / IgG 量立 (ITP)

ITP Gamimune N 5% 400 / 連 1000 / 連數療 24 數度量 1000 / 留不量 1000 /1~2 不量量兩療不來說不 ITP 療數降 30,000/mm 3 / 臨 Gamimune N 5% 400 / 量 800-1000 / 量臨狀數 30,000/mm 3 Gamimune N 5% 量 7 2 理療 (conditioning therapy) 90 500 /(10ml/kg) Gamimune N 5%(Hickman Line) 參量降罹 HIV-1 Gamimune N 5% 量 28 400 /(8mL/Kg) 包裝 250 < 說 >Gamimune N 5% 列量 10 ml 50 ml 0.5 2.5 100 ml 5.0 200 ml 10.0 250 ml 12.5 貯存 2-8 (35-46 ) 不冷不類別有限責任擔保降不良不理量異不更參考文獻 1. Tenold RA, inventor; Cutter Laboratories, assignee. Ontravenously injectable immune serum globulin. U.S. Patent 4,396,608, August 2, 1983. 2. Data on file at Bayer Corporation. 3. Pirofsky B, Campbell SM, Montanaro A: Individual patient variations in the kinetics of intravenous immune globulin administration. J Clin Immunol 2 (2):7S-14S, 1982. 4. Pirofsky B: Intravenous immune globulin therapy in hypogammaglobulinemia. Am J Med 76 (3A):53-60, 1984. 5. Pirofsky B, Anderson CJ, Bardana EJ Jr: Therapeutic and detrimental effects of intravenous immunoglobulin therapy. In: Alving BM (ed.): Immunoglobulins: characteristics and uses of intravenous preparations. Washington, D.C., U.S. government Printing Office, (1980), pp 15-22. 6. Sullivan KM, Kopecky KJ, Jocom J, et al: Immunomodulatory and antimicrobial efficacy of intravenous immunoglobulin in bone marrow transplantation. N Engl J Med 323(11):705-12, 1990. 7. Bernsteim LJ, Ochs HD, Wedgwood RJ, et al: Defective humoral immunity in pediatric acquired immune deficiency syndrome. J Pediatr 107(3):352-7, 1985. 8. Borkowsky W, Steele CJ, Grubman S, et al: Antibody responses to bacterial toxoids in children infected with human immunodeficiency virus. J Pediatr 110(4):563-6, 1987. 9. Blanche S, Le Deist F, Fischer A, et al: Longitudinal study of 18 children with perinatal LAV/HTLV III infection: attempt at prognostic evaluation. J Pediatr 109(6):965-70, 1986. 10. Pahwa S, Fikrig S, Menez R, et al: Pediatric acquired immunodeficiency syndrome demonstration of B-lymphocyte defects in vitro. Diagn Immunol 4(1):24-30, 1986. 11. Bernstein LJ, Krieger BZ, Novick B, et al: Bacterial infections in the acquired immunodeficiency syndrome of children. Pediatr Infect Dis 4(5):472-5, 1985. 12. Krasinski K, Borkowsky W, Bonk S, et al: Bacterial infections in human immunodeficiency virus-infected children. Pediatr Infect Dis J 4(5):323-8, 1988. 13. Scott GB, Buck BE, Leterman JG, et al: Acquired immunodeficiency syndrome in infants. N Engl J Med 310(2):76-81, 1984.

14. Mofenson LM, Willoughby A. Passive immunization. In: Pizzo PA, Wilfert CM, (eds.) Pediatric AIDS: the challenge of HIV infection in ingants, children and adolescents. Baltimore: Williams & Wilkins (1991) pp 633-50. 15. National Institute of Child Health and Human Development Intravenous Immunoglobulin Study Group. Intravenous immune globulin for the prevention of bacterial infections in children with symptomatic human immunodeficiency virus infection. N Engl J Med 325(2):73-80, 1991. 16. Mofenson LM, Moye J Jr, Bethel J, et al: Prophlactic intravenous immunoglobulin in HIV-infected children with CD4+ counts of 0.20 10 9 /L or more. Effect on viral, opportunistic, and bacterial infections. JAMA 268(4):483-88, 1992. 17. Berg G, Matzkies F: Wirkung von Maltose nach intravenoser Dauerinfusion auf den Stoffwechsel. Z Ernahrungswiss 15:255-62, 1976. 18. Forster H, Hoos I, Boecker S: Versuche mit Probanden zur parenteralen Verwertung von Maltose. Z Ernahrungswiss 15(3):284-93, 1976. 19. Finke C, Reinauer H: Utilization of maltose and oligosaccharides after intravinous infusion in man. Nutr Meteb 21(Suppl 1):115-7, 1977. 20. Young EA, Drummond A, Cioletti L, et al:metabolism of continuously infused intravenous maltose. [abstract] Clin Res 25(3):543A, 1977. 21. Soroff HS, Hansen LM, Sasvary D, et al: Clinical pharmacology and metabolism of maltose in normal human volunteers. [abstract] Clin Res 26(3):286A, 1978. 22. Guyton AC: Textbook of Medical Physiology. 5 th ed. Philadelphia, W.B. Saunders, 1976, pp 499-500. 23. Buckley RH: Immunoglobulin replacement therapy: indications and contraindications for use and variable IgG levels achieved. In: Alving BM (ed.): Immunoglobulins: characteristics and uses of intravenous preparations. Washington, D.C., U.S. Government Printing Office, (1980), pp 3-8. 24. Nolte MT, Pirofsky B, Gerritz GA, et al: Intravenous immunoglobulin therapy for antibody deficiency. Clin Exp Immunol 36:237-43, 1979. 25. Ochs HD: Intravenous immunoglobulin therapy of patients with primary immunodeficiency syndromes: efficacy and safety of a new modified immune globulin preparation. In: Alving BM (ed.): Immunoglobulins: characteristics and uses of intravenous preparations. Washington, D.C., U.S. Government Printing Office, (1980), pp 9-14. 26. Sekul E, Cupler E, Dalakas M: Aseptic meningitis associated with high-dose intravenous immunoglobulin therapy: Frequency and risk factors. Ann Int Med 121:259-262, 1994. 27. Kato E, shindo S, Eto Y, et al: Administration of Immune Globulin Associated with Aseptic Meningitis. JAMA 259(22):3269-3270, 1988. 28. Casteels-Van Daele M, Wijndaele L, Hunninck K, et al: Intravenous immune globulin and acute aseptic meningitis. N Engl J Med 323(9):614-615, 1990. 29. Scribner C, Kapit R, Phillips E, et al: Aseptic meningitis and intravenous immunoglobulin therapy. Ann Intern Med 121(4):305-306, 1994. 30. Schiavotto C, Ruggeri M, Rodeghiero F: Adverse reactions after high-dose intravenous immunoglobulin: incidence in 83 patients treated for idiopathic thrombocytopenic purpura (ITP) and review of the literature. Haematologica 78(6:Suppl 2):35-40, 1993. 31. Pasatiempo AM, Kroser JA, Rudnick M, et al: Acute renal failure after intravenous immunoglobulin therapy. J Rheumatol 21(2):347-9, 1994. 32. Peerless AG, Stiehm ER: Intravenous gammaglobulin for reaction to intramuscular preparation. [letter] Lancet 2(8347):461, 1983. Bayer Corporation 8368 U.S. 70 West, Clayton, NC 27520, U.S.A. 104 北路 237 9 樓 (02)25039123