健米喜凍晶注射劑

国: 台湾

言語: 中国語

ソース: 衛生福利部食品藥物管理署 (Ministry of Health and Welfare, Food And Drug Administration)

有効成分:

GEMCITABINE HYDROCHLORIDE;;GEMCITABINE HYDROCHLORIDE;;GEMCITABINE HYDROCHLORIDE

から入手可能:

香港商艾維斯有限公司台灣分公司 台北市中正區忠孝東路二段116號10樓 (70762585)

ATCコード:

L01BC05

医薬品形態:

凍晶注射劑

構図:

GEMCITABINE HYDROCHLORIDE (1010000610) (eq. to Gemcitabine 200mg)MG; GEMCITABINE HYDROCHLORIDE (1010000610) (eq. to Gemcitabine 1000mg)MG; GEMCITABINE HYDROCHLORIDE (1010000610) eq. to Gemcitabine 2000mg)MG

パッケージ内のユニット:

小瓶;;盒裝

クラス:

製　劑

処方タイプ:

限由醫師使用

製:

PHARMACHEMIE B.V. SWENSWEG 5,2031 GA HAARLEM,THE NETHERLANDS NL

治療領域:

gemcitabine

適応症:

非小細胞肺癌、胰臟癌、膀胱癌。Gemcitabine與paclitaxel併用，可使用於曾經使用過Anthracycline之局部復發且無法手術切除或轉移性之乳癌病患。用於曾經使用含鉑類藥物（Platinum-Based）治療後復發且間隔至少6個月之卵巢癌，作為第二線治療。

製品概要:

註銷日期: 2019/04/15; 註銷理由: 自請註銷; 有效日期: 2023/06/07; 英文品名: Gemcitabine Teva Powder for Solution for Infusion

認証ステータス:

已註銷

承認日:

2013-06-07

情報リーフレット

Gemcitabine HCl
Gemcitabine HCl
2
-deoxy-
2
,
2
-difluorocytidine monohydrochloride(
)
Gemcitabine HCl
C
9
H
11
F
2
N
3
O
4
HC
l
299
.
66
Gemcitabine HCl
200
1
2
Gemcitabine HCl(
)
(
200
1
2
)
(
)
(
20
.
7
103
.
7
207
.
3
)
/
Gemcitabine
DNA
(S-
)
G
1
/S
Gemcitabine
nucleoside kinases
diphosphate(dFdCDP)
triphosphate(dFdCTP)
nucleosides
Gemcitabin
DNA
gemcitabine
diphosphate
ribonucleotide
DNA
deoxynucleoside triphosphates
deoxynucleotides
dCTP
Gemcitabine triphosphate
dCTP
DNA
dCTP
(
dip
hosphate
)
Gemcitabine triphosphate
DNA
(
)
Gemcitabine nucleotide
DNA
nucleotide
DNA
DNA
DNA polymerase epsilon
Gemcitabine nucleotide
DNA
(masked chain termination)
CEM T
Gemcitabine
internucleosomal
DNA
Gemcitabine
cisplatin
Cisplatin
Gemcitabine triphosphate
DNA
Gemcitabine
cisplatin
LX-
1
CALU-
6
NCI-H
460
NCI-H
520
Gemcitabine
Lewis
cisplatin
cisplatin
4
Gemcitabine
5
1000
/
/
30
Gemcitabine
92
-
98
%
Gemcitabine(<
10
%)
uracil
2
-deoxy-
2
,
2
-difluorouridine(dFdU)
99
%
dFdU
Gemcitabine
Gemcitabine
353
(<
70
)
(
70
-
285
)
Gemcitabine
500
-
3600
/
Gemcitabine
2
-compartment
Gemcitabine
Gemcitabine
32
-
94
245
-
638
70
50
/
Gemcitabine
370
/
Gemcitabine
30
dFdU(
)
Gemcitabine
Gemcitabine triphosphate
1
.
7
-
19
.
4
Gemcitabine (
1
8
1250
mg/m
2
)
cisplatin (
1
75
mg/m
2
)
Gemcitabine
1
128
L/hr/m
2
8
107
L/hr/m
2
Cisplatin
3
.
94
mL/min/m
2
134
(
-
)
Gemcitabine
paclitaxel
(
)
paclitaxel
Gemcitabine
Gemcitabine
carboplatin
Gemcitabine
carboplatin
-
Gemcitabine
356
(advanced)
(platinum-based)
6
:
21
1
8
Gemcitabine
1000
mg/m
2
1
Gemcitabine
carboplatin
AUC
4
21
1
carboplatin
AUC
5
(progression free survival, PFS)
Gemcitabine
Carboplatin
(PFS)
75
%
Carboplatin
120
13
Gemcitabine
Gemcitabine/Carboplatin
(
178
)
Carboplatin
(
178
)
(
95
%
),
(
95
%
)
8
.
3
(
8
.
0
,
9
.
7
)
5
.
8
(
5
.
2
,
7
.
1
)
p=
0
.
0038
d
0
.
72
(
0
.
57
,
0
.
90
)
(
95
%
),
(
95
%
)
a
(
95
%
)
18
.
0
(
16
.
2
,
20
.
3
)
17
.
3
(
15
.
2
,
19
.
3
)
P=
0
.
8977
d
0
.
98
(
0
.
78
,
1
.
24
)
0
.
86
(
0
.
67
,
1
.
10
)
CR
PR+PRNM
b
42
.
2
%
14
.
6
%
32
.
6