必醫你舒5KE注射劑

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)

资料单张 资料单张 (PIL)
14-06-2021
公众评估报告 公众评估报告 (PAR)
15-04-2020

有效成分:

STREPTOCOCCUS PYROGENE SU STRAIN TX WITH PN G POTASSIUM

可用日期:

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)

ATC代码:

L01XX

药物剂型:

凍晶注射劑

组成:

STREPTOCOCCUS PYROGENE SU STRAIN TX WITH PN G POTASSIUM (5608001231) (14MG)MG

每包单位数:

小瓶

类:

製 劑

处方类型:

限由醫師使用

厂商:

UKIMA PLANT OF CHUGAI PHARMA MANUFACTURING CO., LTD. 5-1, UKIMA 5-CHOME, KITA-KU, TOKYO JAPAN JP

治疗领域:

Other antineoplastic agents

疗效迹象:

消化器癌(胃癌、肝臟癌、膽道癌、大腸癌)頭頸部癌(上顎癌、喉、咽頭癌、舌癌)甲狀腺癌、肺癌

產品總結:

有效日期: 2028/04/20; 英文品名: PICIBANIL 5KE

授权日期:

2017-10-26

资料单张

                                1
2
Benzylpenicillin Potassium
®
0.2 KE 0.5 KE
1 KE
5 KE
•
1
mg
0.56
1.4
2.8
14
mg
0.02
0.2
KE
0.05
0.5
KE
0.1
1
KE
0.5
5
KE
Magnesium sulfate
hydrate
mg
0.02
0.05
0.10
0.48
DL-Methionine
mg
0.04
0.10
0.20
1.00
Maltose hydrate
mg
17.69
17.23
8.37
1.34
Benzylpenicilline
potassium
540
1,350
2,690
13,470
Monobasic potassium phosphate
Sodium hydroxide
Sodium chloride
•
~
pH
2
6.0 ~ 7.5
2
1
1
Lyophilized powder containing the cells of
Streptococcus pyogenes Su strain
A group type 3
treated with benzylpenicillin Potassium
2 •
6.0
® 0.2 KE
PICIBANIL
® 0.2 KE
019928
® 0.5 KE
PICIBANIL
® 0.5 KE
019927
® 1 KE
PICIBANIL
® 1 KE
019923
® 5 KE
PICIBANIL
® 5 KE
019924
1
2~3
0.2~1 KE
2~3
1~3 KE
KE
2 ml
5%
2
1
5-10 KE
2 ml
1
3
1
5-10 KE
2 ml
2~3
4
0.2~0.5 KE
1
3~5
1~5 KE
1~3
KE
2 ml
2
1.
1
2
Cephem
3
2.
1
1
2
3
4
2
3.
26,027
8,312
31.9%
13,092
6,019
23.1%
2,893
11.1%
1,198
4.6%
848
3.3%
789
3.0%
1982
3
352
333
94.6%
1,049
303
86.1%
279
79.3%
210
59.7% CRP
80
22.7%
WBC
64
18.2%
18
5.1%
2008
10
1
1
2
X
3
BUN
2
≥ 5%
< 5%
3
4
5
6
3
GOT
GPT
ALP
BUN
7
CRP
8
CK
CPK
3
4
79.3%
5
59.7%
6
18.2%
7
23.1%
86.1%
8
22.7%
4.
5.
6.
1
2 ml
2
1
2
a.
b.
3
1
2
3
7.
1~
1.
1
1
46
0.2 KE
4
2 KE
2 KE
1
%
100
80
60
40
20
1
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16
p < 0.01
2
311
0.2 KE
2 KE
2 KE
2
2
73
0.2 KE
2 KE
2 KE
3
n=159
n=152
%
100
80
60
40
20
2
0 6 12 18 24 30 36 42 48 54 60
p < 0.05
2.
1
134
76
56.7%
8
6.0%
4
2
25
17
68.0%
6
24.0%
5
3.
6
52
10
5 KE
2~3
10 KE
52
17.3%
10
20.0%
4.
7
0.5 KE/10 ml
1.0 KE/10 ml
20 ml
2
53
75.5%
6
48
85.4%
1.
1
8
methylcholanthorene
9
2
10
11
12
3
13
L1210
fluorouracil
2.
1
14
2
15
16
15
NK
17
CTL
18
IL-1
IL-2
19
IL-8
20
IL-12
21
IFN-r
22
TNF-
α
20
G-CSF
20
GM-CSF
20
3
23,24
TNF
10 C
2
100
1
3
4
: 715
1976
2
Watanabe, Y. et al
J. Biol. Response Mod
6
2
: 169
1987
3
38
4
: 405
1985
4
Torisu, M. et al.
Surgery
93
3
: 357
1983
5
6
5
: 1161
1979
6
32
S-6
: 455
1989
7
31
1
: 29
1995
8
1969
9
1975
10
Biotherapy
4
2
: 155
1990
11
2
6
: 985
1975
12
17
5
: 1284
1982
13 Koshimura, S. et al.
Cancer Treat Rep.
61
1
:
                                
                                阅读完整的文件