国家: 台湾
语言: 中文
来源: 衛生福利部食品藥物管理署 (Ministry of Health and Welfare, Food And Drug Administration)
IMMUNOGLOBULIN HUMAN
傑特貝林有限公司 臺北市信義區基隆路1段333號16樓(1612室) (43836487)
J06BA01
注射液劑
主成分 (Active Ingredients and amount per dose unit:) ; IMMUNOGLOBULIN HUMAN (8004000603) MG/ML
盒裝;;玻璃小瓶裝
菌 疫
限由醫師使用
CSL BEHRING AG UNTERMATTWEG 8, CH-3027 BERN, SWITZERLAND CH
immunoglobulins, normal human, for extravascular adm.
成人、兒童和青少年(0-18歲)之替代療法:(1) 原發性免疫不全症(primary immunodeficiency syndrome)(例如:先天性丙種免疫球蛋白缺乏症(congenital agammaglobulinemia)和丙種免疫球蛋白過低症(hypogammaglobulinemia)、常見變異性免疫不全症(common variable immunodeficiency)、嚴重複合型免疫不全症(severe combined immunodeficiency)及 Wiskott-Aldrich氏症候群)。(2) 慢性淋巴性白血病(chronic lymphocytic leukemia)引致低丙種免疫球蛋白血症及復發性細菌感染,且預防性抗生素治療無效或不適合接受(contra-indicated)預防性抗生素治療的病人。(3)多發性骨髓瘤(multiple myeloma)引致低丙種免疫球蛋白血症及復發性細菌感染的病人者。(4) 異體造血幹細胞移植前後引致丙種免疫球蛋白過低。成人,兒童和青少年的免疫調節療法(0-18歲)Hizentra可作為慢性脫髓鞘多發性神經炎(CIDP)病人的維持療法,於IVIg治療穩定後使用。
有效日期: 2027/11/24; 英文品名: Hizentra
2017-11-24
human immune globulin (hyperviscosity) human immune globulin “ ” 20% HIZENTRA 001048 1. Hizentra 200 mg/ml 2. (SCIg) 1 ml ....................................................................................................200 (98% IgG) 5 ml 1 g 10 ml 2 g 20 ml 4 g 50 ml 10 g IgG() IgG1...............................................................................................................................69% IgG2...............................................................................................................................26% IgG3.................................................................................................................................3% IgG4.................................................................................................................................2% IgA50 / HizentraL-(L-proline) 250 mmol/L (210290) 6.1 3. Hizentra380 mOsmol/kg 4. 4.1 (0-18) (1) (primary immunodeficiency syndrome)( (congenital agammaglobulinemia) (hypogammaglobulinemia)(common variable immunodeficiency)(severe combined immunodeficiency) Wiskott-Aldrich ) (2) (chronic lymphocytic leukemia) (contra-indicated) (3) (multiple myeloma) (4) (0-18) Hizentra(CIDP)IVIg (CIDP) 4.2 (SCIg)/ (CIDP) IgG IgG( ) 5-6 g/l IgG(loading dose) 0.2-0.5 g/kg(1.0-2.5 ml/kg) IgG 0.4-0.8 g/kg (2.0-4.0 ml/kg) ( )() IgG Hizentra 2-3 IgG IgG2 IgG(mg/dL)1 ( 1 ) Hizentra( 2 )( ) ( )1 ( ) 1IGG( ± MG/DL)HIZENTRA (ML) * † IGG (MG/DL) (ML) * >10 30 KG >30 50 KG >50 70 KG >70 90 KG >90 KG 50 ‡ n/a 2.5 5 5 10 5 5 10 10 20 100 2.5 5 10 10 15 5 10 20 20 30 200 5 10 15 20 30 10 20 30 40 60 n/a * IgGHizentra1 mg/kg † 2 ‡ 70 kgIgG 900 mg/dL1000 mg/dL100 mg/dLHizentra10 mL2 2 20 mL2 5 mL Hizentra Hizentra IgG 1 ( ) 2 200 mg/kgHizentra2 400 mg/kg CIDP Hizentra IVIg1 0.2 0.4 g/kg bw 12 1-2IVIG1 1( ) 0.2 0.4 g/kg 1-21-2 Hizentra 0.4 g/kg HizentraCIDP6 6 (IVIG) Hizentra HizentraIVIG5.1 Hizentra68 2 <12(PID) 57 12 <18IgG Hizentra 18CIDP 18 65 Hizentra13> 65(PID) IgG Hizentra61 > 65 (CIDP) HIZENTRA Hizentra Hizentra Hi 阅读完整的文件