孕保寧 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)

有效成分:

ATOSIBAN ACETATE CORRESPONDING TO ATOSIBAN

可用日期:

輝凌藥品股份有限公司 台北市中山區松江路111號11樓 (86386138)

ATC代码:

G02CX01

药物剂型:

注射劑

组成:

ATOSIBAN ACETATE CORRESPONDING TO ATOSIBAN (7600001820) MG

每包单位数:

小瓶

类:

製　劑

处方类型:

限由醫師使用

厂商:

FERRING GMBH WITTLAND 11, D-24109 KIEL GERMANY DE

治疗领域:

atosiban

疗效迹象:

延遲妊娠婦女迫切的早產。

產品總結:

有效日期: 2026/11/13; 英文品名: Tractocile solution for injection 7.5mg/ml

授权日期:

2006-11-13

资料单张

2009053314
7.5atosiban
7.5atosiban
atosiban
0.75 mg/ml.
Mannitol, hydrochloric acid 1M and water for injections
(0.9 ml)6.75
(5 ml)37.5
TRACTOCILE
®
- 30304
- 1-3(0-3)50%
- 18
- 24-33
-
TRACTOCILE
®
TRACTOCILE
®
TRACTOCILE
®
7.5 mg/ml6.753
TRACTOCILE
®
7.5 mg/ml
(
300/)TRACTOCILE
®
7.5 mg/ml
(
100
/
)
45
48
TRACTOCILE
®
330
(atosiban
)
TRACTOCILE
®
TRACTOCILE
®
TRACTOCILE
®
atosiban
1-(3-
)-2-(O-
-D-
)-4-L-
-8-L-
-
Atosiban
atosiban
Atosiban
Atosiban
atosiban
atosiban
10
12
(≤4
/)
III
(CAP-001)
742
23
33
atosiban (
)
β-
(
7
7
TRACTOCILE
®
59.6% (n=201)
β-
47.7% (n=163, p=0.0004)
CAP-001
TRACTOCILE
®
(n=48, 14.2%)
(p=0.0003)
β-
(n=20, 5.8%)
CAP-001
24
28
7
atosiban
β-
(n=129 )
48
atosiban
β-
(p=0.37)
atosiban
35.9 (3.9)
β-35.3 (4.2)
(
30
)
Atosiban
2491 (813)
β-
2461 (831)
(p=0.58)
atosiban
β-
III 361atosiban
73
8
2
()
atosiban
24
atosiban
()
/
5/295 (1.7)atosiban
15/288 (5.2)Atosiban
Atosiban
20
24
atosiban
(19
atosiban
4
)
24
(
1.7
atosiban
1.5
)
atosiban
(10-300
/12)
atosiban
(10-300
/
6-12
)
(
442±73
ng/ml298533 ng/ml
)
(t
α
) 0.21±0.01
(t
β
) 1.7±0.3
41.8±8.2
/
18.3±6.8
atosiban
46
48
Atosiban
Atosibanatosiban 300/
/atosiban
0.12
M1(des- (Orn
8
, Gly-NH
2
9
) -[Mpa
1
,D-Tyr (Et)
2
, Thr
4
]-oxytocin)
atosiban
1.4
2.8
M1
atosiban
atosiban
M1
50
atosiban
M1oxytocinatosiban
10
M1()
TRACTOCILE
®
()
Atosiban
Cytochrome P450
(
)
(
)
(20
mg/kg/day )
atosiban
oxytocin
Atosiban
4
24
28°C
0.9
TRACTOCILE
®
7.5
/
0.9
TRACTOCILE
®
7.5/
()
7.5
/
TRACTOCILE
®
- 0.9% (w/v)
-
- 5% (w/v)
100
10
10
7.5
/
TRACTOCILE
®
(
5
)
1 0 0
7 5
TRACTOCILE
®
24
18
3
3
8
100
/
TRACTOCILE
®
(
)
Ferring GmbH
Wittland 11, D-24109 Kiel,
Germany
Ferring Léčiva a.s.
Ke Skále 455, 252 42 Vestec u Prahy,
Czech Republic
11111
024562
TRACTOCILE
® SOLUTION FOR INJECTION 7.5 MG/ML
024561
TRACTOCILE
® CONCENTRATE FOR SOLUTION FOR INFUSION 7.5 MG/ML
1
2
3
0.9
3
1
24/
8/
6.75
18/
6/
MedDRA
(≥10%)
(≥1- <10%)
(≥0.1- <1%)
(≥0.01- <0.1%)
TRACTOCILE
®
TRACTOCILE
®
7.5 mg/mlTRACTOCILE
®
7.5 mg/ml
TRACTOCILE
®