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)
emicizumab
台灣中外製藥股份有限公司 台北市松山區敦化北路260號3樓 (23060795)
B02BX06
注射液劑
emicizumab (2012103500) MG/ML
盒裝
菌 疫
限由醫師使用
Bushu Pharmaceuticals Ltd. Kawagoe Factory 1 Takeno, Kawagoe, Saitama, 350-0801, Japan JP
emicizumab
適用於帶有或未帶有第八凝血因子抗體的A型血友病(先天性第八凝血因子缺乏)病人之出血事件常規性預防。
有效日期: 2028/08/28; 英文品名: HEMLIBRA SC Injection 30 mg/mL
2018-08-28
1. ® 150 / HEMLIBRA ® SC Injection 150 mg/mL ® 30 / HEMLIBRA ® SC Injection 30 mg/mL 2. Hemlibra 30 mg/mL mL 30 mg emicizumab* 1 mL 30 mg emicizumab 30 mg/mL Hemlibra 150 mg/mL mL 150 mg emicizumab* 0.4 mL 60 mg emicizumab 150 mg/mL 0.6 mL 90 mg emicizumab 150 mg/mL 0.7 mL 105 mg emicizumab 150 mg/mL 1 mL 150 mg emicizumab 150 mg/mL * Emicizumab DNA CHO G4 IgG4 6.1 3. 4. 4.1 A 4.2 / Hemlibra aPCC rFVIIa 4.4 Hemlibra 7 FVIII 4 3 mg/kg 1.5 mg/kg 2 3 mg/kg 4 6 mg/kg / mg mL • 4 3 mg/kg kg 3 mg/kg = emicizumab mg • 5 1.5 mg/kg 2 3 mg/kg 4 6 mg/ kg kg 1.53 6 mg/kg = emicizumab mg Hemlibra emicizumab mg mg/mL = Hemlibra mL Hemlibra 30 mg/mL 150 mg/mL 16 kg 1.5 mg/kg • 4 16 kg 3 mg/kg = 48 mg emicizumab • 48 mg 150 mg/mL 48 mg emicizumab150 mg/mL = 0.32 mL 150 mg/mL Hemlibra • • 516 kg 1.5 mg/kg = 24 mg emicizumab • 24 mg 30 mg/mL 24 mg emicizumab30 mg/mL = 0.8 mL 30 mg/mL Hemlibra • 40 kg 2 3 mg/kg • 440 kg 3 mg/kg = 120 mg emicizumab • 120 mg 150 mg/mL 120 mg emicizumab150 mg/mL = 0.8 mL 150 mg/mL Hemlibra • • 540 kg 3 mg/kg = 120 mg emicizumab • 120 mg 150 mg/mL 120 mg emicizumab150 mg/mL = 2 0.8 mL 150 mg/mL Hemlibra • 5 ≥ 1 < 2 55 12 50 12 <18 A emicizumab emicizumab 13 65 77 emicizumab < 65 ≥ 65 emicizumab A emicizumab emicizumab A N=332 [ CLcr ] ≥ 90 mL/min N=27 CLcr 60-89 mL/min emicizumab Hemlibra 2 CLcr 30-59 mL/min emicizumab Hemlibra emicizumab A AST ≤ ULNN=300 ≤ ULN AST > ULN 1.0 1.5 ULN AST N=51 6 1.5 ULN < ≤ 3 ULN AST emicizumab 4.2 emicizumab n=4 Hemlibra Emicizumab emicizumab 5.3 30 mg/kg/week AUC 3 mg/kg/week 11 emicizumab emicizumab – / 6. 6.1 L-Arginine L-Histidine L-Aspartic acid Polyoxyethylene 160 polyoxypropylene 30 glycol 6.2 Hemlibra 6.3 2 30 ºC 7 7 30 ºC 7 30 ºC 6.4 2 ºC 8 ºC 6.3 6.5 Hemlibra 30 / 3 mL 1 1 mL 30 mg emicizumab Hemlibra 150 / 3 mL 1 60 kg 4 6 mg/kg • 460 kg 3 mg/kg = 180 mg emicizumab • 180 mg 150 mg/mL 180 mg emicizumab150 mg/mL = 1.20 mL 150 mg/mL Hemlibra • • 560 kg 6 mg/kg = 360 mg emicizumab • 360 mg 150 mg/mL 360 阅读完整的文件