卡蒲鉑定"山德士"注射劑10毫克/毫升

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)

Aktiv bestanddel:

CARBOPLATIN

Tilgængelig fra:

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)

ATC-kode:

L01XA02

Lægemiddelform:

注射劑

Sammensætning:

CARBOPLATIN (1004001500) MG

Enheder i pakken:

小瓶裝;;盒裝

Klasse:

製　劑

Recept type:

限由醫師使用

Fremstillet af:

EBEWE PHARMA GES.M.B.H.NFG. KG MONDSEESTRABE 11,AT-4866 UNTERACH AM ATTERSEE, AUSTRIA AT

Terapeutisk område:

carboplatin

Terapeutiske indikationer:

卵巢癌。

Produkt oversigt:

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

Autorisation status:

已註銷

Autorisation dato:

2012-02-17

Indlægsseddel

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%