顆球諾得５０

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)

有效成分:

LENOGRASTIM (GENETICAL RECOMBINATION)

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:

L03AA10

药物剂型:

凍晶乾燥注射劑

组成:

主成分 () ; LENOGRASTIM (GENETICAL RECOMBINATION) (9200035800) MCG

每包单位数:

小瓶;;盒裝;;安瓿附溶液

类:

菌　疫

处方类型:

限由醫師使用

厂商:

Nipro Pharma Corporation Ise Plant 647-240, Ureshinotengeji-cho, Matsusaka-shi, Mie 515-2302, Japan JP

治疗领域:

lenograstim

疗效迹象:

1.促進造血幹細胞移植時的嗜中性白血球數的增加。2.癌症化學療法所引起之嗜中性白血球缺乏症。3.伴隨著骨髓發育不良症候群的嗜中性白血球減少症。4.先天性、特異性嗜中性白血球缺乏症。5.動員造血幹細胞至週邊血液中。

產品總結:

註銷日期: 2020/09/01; 註銷理由: 自請註銷; 有效日期: 2023/04/22; 英文品名: GRANOCYTE 50

授权状态:

已註銷

授权日期:

2003-02-12

资料单张

1
2
•
1
•
pH
1
1
GRANOCYTE
50
LENOGRASTIM
50 µg
L-arginine
L-phenylalanine
L-methionine
Polysorbate 20
D-mannitol
6.0 ~ 7.5
1
100
100 µg
6.0 ~ 7.5
1
250
250 µg
6.0 ~ 7.5
1 ~ 2
1
JP
1
1
•
•
•
•
•
•
5 µg/kg
2
10 µg/kg
50,000/
mm
3
75,000/mm
3
Granocyte
10 µg/kg
2
4~6
Granocyte
10 µg/
kg
2
4~6
5 µg/kg
5,000/mm
3
2.
1
1
10
20
40 µg
/
***
10
20
40 µg
/
***
20 µg
/
***
***
2~10 µg/kg
1.
2
3,4
5,6
7-9
2.
10
3.
11,12
13
14-16
17-20
21
22
23
4.
24
25
1.
1
28
2
29,30
31
3
32
33
1
2
1 P. AERUGINOSA
7
32
CPA
mg/kg
i.p.
µg/kg
s.c.
cfu /
10
4
10
5
10
6
10
7
0
0
5/5
5/5
5/5
0/5
200
0
3/5
0/5
NT
NT
200
1
5/5
2/5
NT
NT
200
10
5/5
4/5
1/5
NT
200
100
5/5
5/5
2/5
NT
2 C. ALBICANS
33
20 Takeshita, A. et al.: Int J Hematol., 71:136 2000
21
7 10 :1123 1994
22
Biotherapy, 13 6 :711 1999
23
Biotherapy, 7 12 :1709 1993
24
Biotherapy, 4 10 :1644 1990
25
32 7 :743 1991
26
Virus
24 5 :399 1996
27
30 1 :30 1995
28
1999
29
18 S-9 :S2487 1990
30
18 S-9 :S2535 1990
31
18 S-9 :S2469 1990
32 Matsumoto, M. et al.: Microbiol. Immunol., 34 9 :765 1990
33 Matsumoto, M. et al.: J. Antimicrob. Chemother., 28:447 1991
34
1990
35
1995
36 Kubota, N. et al.: J. Biochem., 107:486 1990
37 Oheda, M. et al.: J. Biochem., 103:544 1988
38
1 1 :63 1990
39
1989
260
3
TEL [phone]
Utsunomiya Plant of Chugai Pharma Manufacturing Co.,
Ltd.
P 16-3 Kiyohara Kogyodanchi, Utsunomiya-city,
Tochigi, Japan
O 5-1 Ukima 5-Chome, Kita-Ku, Tokyo, Japan
N
ipro Pharma Corporation Ise Plant.
647-240, Ureshinotengeji-cho, Matsusaka-shi, Mie 515-
2302, Japan.
260
3
TEL [phone]
JPI Jun 2018
JPI version 24
CPA
mg/
kg i.p.
µg/kg
s.c.
AMPH-B
mg/kg
i.v.
cfu
/
1
2
3
200
0
0
5.110
6
0/8
0/8
0/8
200
0
0.5
5.110
6
10/10
9/10
0/10
200
100
0.5
5.110
6
10/10
10/10
10/10
CPA
Cyclophosphamide
AMPH-B
Amphotericin B
4
34
5
in vitro
35
in
vivo
35
2.
1
G-CSF
36,37
38
2
-
CFU-
GM
BFU-E, CFU-E
CFU-Meg
in vitro
39
Lenograstim genetical recombination
JAN
20,000
174
mRNA
cDNA
30
50 µg
100
100 µg
100
250 µg
100
1
JP
1
26 11 :1660 1989
2 Linch, D.C. et al.: Br. Haema