立肺治凍晶注射劑 0.5 毫克

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:

EPOPROSTENOL SODIUM

可用日期:

嬌生股份有限公司 台北市中山區民生東路三段2號10樓及11樓 (30814854)

ATC代码:

C02KX

药物剂型:

凍晶注射劑

组成:

EPOPROSTENOL SODIUM (2012102710) MG

每包单位数:

盒裝

类:

製　劑

处方类型:

限由醫師使用

厂商:

PATHEON ITALIA S.P.A. VIALE G.B. STUCCHI, 110-20900 MONZA (MB), ITALY IT

治疗领域:

Antihypertensives for pulmonary arterial hypertension

疗效迹象:

適用於治療結締組織疾病續發肺動脈高血壓之WHO功能分級III和IV的患者，以改善運動能力

產品總結:

有效日期: 2028/05/18; 英文品名: VELETRI Lyophilized Powder for Injection 0.5 mg

授权日期:

2018-05-18

资料单张

®
0.5
VELETRI
®
Lyophilized Powder for Injection 0.5 mg
®
1.5
VELETRI
®
Lyophilized Powder for Injection 1.5 mg
027438
027437
-----------------------------------------------
-----------------------------------------------
VELETRI WHO
IIIIV
--------------------------------------------------
--------------------------------------------------
●
- VELETRI 2 ng/kg/min 15 (
)
2 ng/kg/min
[2.1]
- (
15
) 1 2 ng/kg/min [2.2]
●
- VELETRI [2.3]
- [2.4)
●
- 5 mL 0.9%
- VELETRI
1
[2.4]
- [2.4]
------------------------------------------------
------------------------------------------------
(10 mL) 0.5 mg (500,000 ng) 1.5 mg (1,500,000 ng) VELETRI[3]
----------------------------------------------------
----------------------------------------------------
●
[4]
●
[4]
●
[4]
--------------------------------------------
--------------------------------------------
●
VELETRI [5.1]
●
0.9% [5.1]
●
[5.3, 5.4]
--------------------------------------------------
--------------------------------------------------
●
-
[6.1]
- / [6.1]
-----------------------------------------------
-----------------------------------------------
●
[7]
●
[7]
●
[7]
"" [16]
1.
WHO IIIIV
2.
VELETRI (USP)
0.9% (USP)
VELETRI "
" [5.1] )
2.1
VELETRI
VELETRI
2 ng/kg/min 15
2 ng/kg/min
VELETRI
2 ng/kg/min
12 PAH/SSD
2.2 ng/kg/min
7 7 4.1 ng/kg/min 12
11.2 ng/kg/min 3 2 3 ng/kg/min
2.2
VELETRI
15
1
2 ng/kg/min
24 48
15
2 ng/kg/min
"
" [6.1
6.2] VELETRI
VELETRI
epoprostenol
2.3
VELETRI "" [2.4]
VELETRI
0.22 (in-line filter)
VELETRI (1)
(2)
2 ng/
kg/min (3)
(4)
±
6% (5) VELETRI
3
CADD-1
HFX 5100 (SIMS Deltec) (0.9 mL)
0.22 DEHP 60
2.4
VELETRI (USP ) 0.9% (USP)
VELETRI
VELETRI VELETRI
(25
°
C)
5 mL (USP) 0.9% (USP)
VELETRI
1
1 (25
°
C) *
2
°
8
°
C
8
0.5 mg
≥ 3,000 ng/mL < 15,000 ng/mL
48
24
1.5 mg
≥ 15,000 ng/mL < 60,000 ng/mL
48
48
≥ 60,000 ng/mL
72
48
* 40
°
C
2 15,000 ng/mL
4 15,000 ng/mL 60,000 ng/mL
8 60,000 ng/mL
(> 25
°
40
°
C)
25
°
C
30
°
C 60,000 ng/mL VELETRI
48 2
°
8
°
C 8
60,000 ng/mL 24
40
°
C 60,000 ng/mL VE