菲塔敏思 20 微克/毫升

Država: Tajvan

Jezik: kitajščina

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

Aktivna sestavina:

ILOPROST

Dostopno od:

台灣拜耳股份有限公司 台北市信義區信義路5段7號53樓 (23167184)

Koda artikla:

B01AC11

Farmacevtska oblika:

吸入用液劑

Sestava:

ILOPROST (6832002300) MG

Enote v paketu:

盒裝

Razred:

製　劑

Tip zastaranja:

須由醫師處方使用

Izdeluje:

BERLIMED S.A. C/FRANCISCO ALONSO, 7 POLIGONO INDUSTRIAL SANTA ROSA 28806 ALCALA DE HENARES (MADRID), SPAIN ES

Terapevtsko območje:

iloprost

Terapevtske indikacije:

原發性肺動脈高血壓。

Povzetek izdelek:

有效日期: 2028/05/07; 英文品名: Ventavis Nebuliser Solution 20 μg/ml

Datum dovoljenje:

2018-05-07

Navodilo za uporabo

1.
20 /Ventavis Nebuliser Solution 20 µg/ml
2.
120iloprost (iloprost trometamol)
(6.1“”)
3.
4.
4.1
4.2
“
/
”
(4.5)
●
Breelib
Ventavis 10 microgram/ml
2.5
iloprost
ventavis 20 microgram/ml5.0iloprost
Ventavis
2.5
iloprost (
)
5.0
5.0
2.5
69
4-10
●
●
(18
)
●
(5.2)
2.5
3-4
(
6
)
5.0
3-4
●
(creatinine)
>30 ml/min (Cockroft-Gault
)
30 ml/min
iloprost
4.4.5
3-4(4.2“”)
4.4.6
Ventavis
Ventavis
(4.6“”)
iloprost
Ventavis(4.6“”)
4.4.7 BREELIB
Breelib
Breelib
3
Ventavis
Breelib
Ventavis 10
/
2.5
iloprost
2.5
5.0
Ventavis 10/Ventavis 20
/
5.0
iloprost
Ventavis
20
/
Ventavis 10
/
(“”)
4.5
Iloprost
(
4.4“
”)
Ventavis
iloprost
(
heparin, coumarin
)
(
(
theophylline
pentoxifylline
dipyridamole
trapidil
ibudilast)
3 (PDE3)
(
amrinone
enoximone
milrinonecilostazol
anagrelide)
)
iloprost
(
4.8“
”)
8
300
(acetylsalicylic acid)
iloprost
iloprost
digoxin
t-PA
iloprost
cytochrome P450
iloprost
4.6
4.6.1
(PH)
/
(
)
Ventavis
Ventavis
(
4.4“
”)
4.6.2
/
iloprost
(
1
iloprost
)
Ventavis
(
4.4“
”)
4.7
4.8
4.8.1
iloprost
(≥20%)
4.8.2
Ventavis
(MedDRA
SOCs)MedDRA
(ADR)
131
≥1/10≥1/100< 1/10
“” 20
/
VENTAVIS NEBULISER SOLUTION 20 ΜG/ML
000053
4.3
-
(
)
-
-
-
-
-
- ()
-
-
-
4.4
4.4.1
(
4.5“
”)
(1
2
)
(therapeutic gaps)
/
/
(4.8“”)
4.4.2
Ventavis
85 mm Hg
4.4.3
(
4.8“
”)
(COPD)
4.4.4 (PVOD)
(MEDDRA)
*
§
/
§
*
§
*
/
*
/
§
4.8.3 ”
4.8.3
(4.4“”)
(
)
(
4.5“
”)
12.2%
iloprost
16.2%
4.9
4.9.1
4.9.2
8
iloprost
10 ml/min/kg
iloprost
5.3
•
prostacyclin
(
)
apathy
()14
ng/kg/min
()
14
47
(
)
26
26
48.7
/
/
(NOAEL)
10(13)(AUC)
•
iloprost
•
iloprost
iloprost
(
iloprost
1%)
•
20
iloprost
26
()
6.
6.1
Trometamol
Ethanol
Sodium chloride
Hydrochloric acid
Water for injections
6.2
6.3
6.4
30
6.5
1 ML
100
6.6 /
6.6.1
BreelibVentavis 20/
5iloprost(MMAD; Mass Median
Aerodynamic Diameter)1-5
Ventavis
6.6.2 BREELIB
Breelib
Ventavis
CCDS version 13 / Mar 2017
Berlimed S.A.
C / Francisco Alonso 7, Poligono Industrial Santa Rosa, 28806 Alcala
de
Henares (Madrid), Spain
57101535