Land: Taiwan
Sprog: kinesisk
Kilde: 衛生福利部食品藥物管理署 (Ministry of Health and Welfare, Food And Drug Administration)
LONOCTOCOG ALFA (rVIII-SingleChain)
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)
B02BD02
凍晶乾燥注射劑
LONOCTOCOG ALFA (rVIII-SingleChain) (2003001000) IU
玻璃小瓶裝
菌 疫
限由醫師使用
AGC BIOLOGICS A/S VANDTAARNSVEJ 83B, DK-2860 SOEBORG, COPENHAGEN, DENMARK DK
coagulation factor VIII
罹患A型血友病(先天性第八凝血因子缺乏症)病人的出血治療及預防
有效日期: 2024/12/11; 英文品名: Afstyla 250IU
2019-12-11
250 Afstyla 250 IU : 001102 500 Afstyla 500 IU : 001103 1000/2000 Afstyla 1000 IU/ 2000 IU : 001104 1. 2 5 0 5 0 0 1000 2000 2. 250 250rVIII-SingleChain lonoctocog alfa2.5100 500 500rVIII-SingleChain lonoctocog alfa2.5200 1000 1000 rVIII-SingleChain lonoctocog alfa2.5400 2000 2000rVIII-SingleChain lonoctocog alfa 5400 (chromogenic assay) 7400 – 16000 CHO B (domain)a34 765~1652 N B a3 furin 25050010002.5 17.5 0.76 15002000250030005 35 1.52 6.1 3. 6.6 - 7.3 500 – 600 4. 4.1 A 4.2 (coagulation analysis) aPTT(one-stage clotting assay) (chromogenic assay)/ 45% 2 IU IU (potency assignment) (chromogenic substrate assay) (on demand treatment) 1 2/100(IU/dL) IU = kg × IU/dL% × 0.5 IU/dLIU/kg %IU/dL / % IU/ DL / 20 - 40 12 241 30 - 60 12 24 3 4 60 - 100 8 24 30 - 60 241 80 - 100 8 24 7 30% 60% IU/ dL 20 50/ 23 12 30 50 2 3 12 125.2 65 10/ 6.6 4.3 6.1 4.4 (hypersensitivity reactions) (hives)(urticarial) (anaphylaxis) A IgG Bethesda Units BU / 50 2 4.2 central venous access device, CVAD 7 0.3 4.5 4.6 A 4.7 4.8 ( ) A SOC A ≥1/10≥1/100 <1/10≥1/1,000 <1/100≥1/10,000 <1/1,000 <1/10,000 PTPs* PUPs * * A PTPs = PUPs = ( :02-23960100) 4.9 5. 5.1 ATCB02BD02 lonoctocog alfa B VWF / A 12 – 65 1001 175 A 1265 1 60 14,306 (EDs)(anaphylactic reaction) 146 1.14 0.0, 4.279 54% 47 32% 2 3 35 30 / 4,283 / 100184893.5% 34.7/ 10011316 18 12 30028412356 49 6 125,239 (EDs)(anaphylactic reaction) 803.69 0.00, 7.204353%2430% 2 3 35 32/ 4,109/ 300234795.7% 27.6/ ABR 5.2 81 A <1%18-6050 ( 4.2 )3~6 50 – 50 81 % IR100 2.00 (20.8) 1.99 (0.868, 2.90) C max 100 106 (18.1) 106 (62.4, 151) AUC 0-inf *100 1960 (33.1) 1910 (932, 4090) t 12 14.2 (26.0) 13.7 (7.54, 23.9) MRT 20.4 (25.8) 20.2 (10.8, 35.1) CL 2.90 (34.4) 2.67 (1.26, 5.79) V ss 55.2 (20.8) 53.2 (32.4, 99.6) IR = 30C max =AUC 0-inf = – t 1 2 = MRT = CL =80 V ss =IR C max (81) PK50 101218390 12A<1% 4.2 50 – 06 20 % 612 19 % 1218 10 % IR 100 1.60 (21.1) 1.55 (1.18, 2.76) 1.66 (19.7) 1.69 (0.92, 2.35) 1.69 (24.8) 1.76 (0.88, 2.44) C max 100 80.2 (20.6) 78.6 (59.3, 138) 83.5 (19. Læs hele dokumentet