Страна: Тайван
Език: китайски
Източник: 衛生福利部食品藥物管理署 (Ministry of Health and Welfare, Food And Drug Administration)
CARBOPLATIN
台灣諾華股份有限公司 台北市中山區民生東路三段2號8樓 (01516589)
L01XA02
注射劑
CARBOPLATIN (1004001500) MG
小瓶裝;;盒裝
製 劑
限由醫師使用
EBEWE PHARMA GES.M.B.H.NFG. KG MONDSEESTRABE 11,AT-4866 UNTERACH AM ATTERSEE, AUSTRIA AT
carboplatin
卵巢癌。
註銷日期: 2021/07/05; 註銷理由: 自請註銷; 有效日期: 2022/02/17; 英文品名: Carboplatin "Ebewe" 10mg/ml concentrate for solution for infusion
已註銷
2012-02-17
11780089–01 ""10/ CARBOPLATIN "EBEWE" 10MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION H 3 N H 3 N Pt Carboplatin (carboplatin ) Carboplatin Carboplatin (epinephrine) mlcarboplatin 10 mg Carboplatin Carboplatin platinum, diamine [1,1-cyclobutane- dicarboxylato(2-)-0,0']-(SP-4-2) CarboplatinC 6 H 12 N 2 O 4 Pt317.2514 mg/ml1% pH5~7 Carboplatin cisplatin DNA DNA carboplatin (aquation) cisplatin Carboplatin cisplatin DNA Carboplatincisplatin 60 (ml/min) Carboplatin 300 mg/m 2 500 mg/m 2 carboplatin (biphasic manner)(alpha)1.12(N=6)(beta) 2.6 5.9 (N=6) Carboplatin 4.4 16 3.5 (C max ) ( ) (AUC inf ) carboplatin(300 mg/m 2 ~500 mg/m 2 ) Carboplatin carboplatin carboplatin 5 Carboplatin 60 12 65% 24 71% 24 carboplatin 3% 5% 24 96 60 carboplatinCarboplatin( ) Carboplatin (GFR) GFRCarboplatinCarboplatinAUC cyclophosphamide (NCIC) (SWOG) 789 Carboplatin cisplatin cyclophosphamide28 025626 () Cisplatin Carboplatin Cytoxan 2() NCIC 447 60 75 mg/m 2 300 mg/m 2 60 mg/m 2 39% (174/447) SWOG 342 62 100 mg/m 2 300 mg/m 2 600 mg/m 2 14% (49/342) Carboplatin () Cisplatin () 95% C.I.(Carboplatin-Cisplatin) NCIC 60% (48/80) 58% (49/85) (-13.9%, 18.6%) SWOG 58% (48/83) 43% (33/76) (-2.3%, 31.3%) Carboplatin () Cisplatin () 95% C.I.(Carboplatin-Cisplatin) NCIC 11% (24/224) 15% (33/323) (-10%, 2.5%) SWOG 10% (17/117) 10% (17/171) (-6.9%, 6.9%) * * NCIC Carboplatin 114 Cisplatin 109 SWOG Carboplatin90Cisplatin106 Carboplatin Cisplatin PFS* Carboplatin Cisplatin 95% C.I.(Carboplatin-Cisplatin) PFS* Carboplatin Cisplatin 95% C.I.(Carboplatin-Cisplatin) ** 95% C.I.(Carboplatin-Cisplatin) NCIC 59 61 31% 31% (-9.3, 8.7) 19% 23% (-11.5, 4.5) 1.10 (0.89, 1.35) SWOG 49 47 21% 21% (-9.0, 9.4) 8% 14% (-14.1, 0.3) 1.02 (0.81, 1.29) (PFS) *Kaplan-Meier () ** Carboplatin Cisplatin PFS* Carboplatin Cisplatin 95% C.I.(Carboplatin-Cisplatin) PFS* Carboplatin Cisplatin 95% C.I.(Carboplatin-Cisplatin) ** 95% C.I.(Carboplatin-Cisplatin) NCIC 110 99 51.9% 48.4% (-6.2, 13.2) 34.6% 33.1% (-7.7, 10.7) 0.98 (0.78, 1.23) SWOG 86 79 40.2% 39.0% (-9.8, 12.2) 18.3% Прочетете целия документ