Country: Թայվան
language: չինարեն
source: 衛生福利部食品藥物管理署 (Ministry of Health and Welfare, Food And Drug Administration)
Human Immunoglobulin G
醫療財團法人台灣血液基金會 台北市中正區南海路3號3樓 (01010553)
J06BA02
注射劑
Human Immunoglobulin G (8004000650) MG
瓶裝
菌 疫
限由醫師使用
CSL BEHRING (AUSTRALIA) PTY LTD 189-209 CAMP ROAD BROADMEADOWS VICTORIA 3047 AUSTRALIA AU
immunoglobulins, normal human, for intravascular adm.
IgG的替代治療用藥,適應症包括:1.原發性免疫不全症(primary immune deficiency)。2.由潛在疾病或治療所引發之次發性症狀性低伽瑪球蛋白血症。用於改善免疫調節機能,適應症包括:3.原發性血小板缺乏性紫斑症【idiopathic thrombocytopenic purpura(ITP)】,高危險出血的成人或小孩ITP患者;或者,手術前用以修正血小板數目。4.異體骨髓移植(allogeneic bone marrow transplantation)。5.川崎氏症(Kawasaki Disease)。6. Guillain-Barré 症候群(Guillain-Barré Syndrome (GBS))。
有效日期: 2027/07/12; 英文品名: "TBSF" Human Immunoglobulin for Intravenous Use
2007-07-12
“ ” "TBSF" Human Immunoglobulin for Intravenous Use 000841 1human immune globulin 2 3 4human immune globulin 5 6 “ ” 100 ml6 g10 gpH4.25 98% G90% IgG (preclinical batches)(clinical batches) “ ” IgG 61% IgG 1 , 36% IgG 2 , 3% IgG 3 1% IgG 4 “ ” IgA (Immunoglobulin A)(< 0.025 mg/mL) “ ” “ ” IgG IgGIgG “ ” (60 ° C10 )pH “ ” Intragam ® P Intragam ® PCSL Limited (IVIg) “ ” IgG • (primary immune deficiency (PID)) • “ ” • (Idiopathic Thrombocytopenic Purpura (ITP)) ITP • (allogeneic bone marrow transplantation) • (Kawasaki Disease) • Guillain-Barré (Guillain-Barré Syndrome (GBS)) IVIgITP 1, 2 (Replacement therapy) “ ” IgG5 g/L 0.2-0.6 g IgG/kg (0.4-0.6 g IgG/kg) IgG (Immunomodulatory therapy) (Idiopathic Thrombocytopenic Purpura (ITP)) “ ” 2 52 g IgG/kg (Kawasaki disease) “ ” 2 51.6-2.0 g IgG/kg 2 g IgG/kg (Allogeneic bone marrow transplantation) “ ” (conditioning regime) “ ” 0.5 g IgG/kg Guillain Barré(Guillain Barré Syndrome (GBS)) “ ” 0.4g IgG/kg “ ” “ ” “ ” 1 mL (60 mL) 15 15 3-4 mL (180-240 mL) “ ” IVIgIVIg ( “ - ” ) “ ” “ ” 0.9%5% “ ” 1. 2. 3. 4. 5. 6. 7. ( (cannula)) 8. “ ” 9. “ ” • • IgAIgA • “ ” IVIg • • IgA(agammaglobulinemia) (hypogammamaglobulinemia) • “ ” IgA IgA IgA(IgA deficiency) (anaphylactoid reaction) IVIg 65 (volume depletion)(sepsis)(monoclonal gammopathy)(nephrotoxic) ( ) IVIgIVIg “ ” IVIg IVIg IVIg IgG ( / ) / IVIg (IVIg)(Aseptic Meningitis Syndrome (AMS))IVIg (photophobia) (cerebrospinal fluid, CSF) (pleocytosis)(granulocytic series) AMSIVIg (2 g/kg) IVIgAMS ( A B D ) (direct antiglobulin test)(haemolysis) (crossmatching) IVIg ( 40.4 g/ kg)O IVIg( 0.4 g/kg)ABO IVIg/ IVIg (0.4 g/kg) (6 ) (thrombophlebitis) (Creutzfeldt-Jakob Disease, CJD) HIV () BC A parvovirus B19 parvovirus B19 “ ” 65 “ ” ( A B D) (Coombs) “ ” “ ” / “ ” “ ” “ ” “ ” () / , “ ” “ ” “ ” “ ” “ ” “ ” “ INTRAGAM ® P ” (Primary read_full_document