易擴樂即能322微克乾粉吸入劑

Land: Taiwan

Språk: kinesisk

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

Aktiv ingrediens:

Micronised aclidinium bromide

Tilgjengelig fra:

臺灣阿斯特捷利康股份有限公司 台北市大安區敦化南路二段207號21樓 (16440975)

ATC-kode:

R03BB05

Legemiddelform:

乾粉吸入劑

Sammensetning:

主成分 (本品製劑每一劑量(metered dose)含：) ; Micronised aclidinium bromide (1208008910) MG

Enheter i pakken:

含劑量計數之吸入器;;塑膠殼裝

Klasse:

製　劑

Resept typen:

須由醫師處方使用

Produsert av:

INDUSTRIAS FARMACEUTICAS ALMIRALL, S.A. CTRA. NACIONAL II, KM 593, 08740 SANT ANDREU DE LA BARCA, BARCELONA, SPAIN ES

Terapeutisk område:

aclidinium bromide

Indikasjoner:

適用於慢性阻塞性肺病(COPD)患者之長期維持性支氣管擴張治療。

Produkt oppsummering:

註銷日期: 2022/02/22; 註銷理由: 自請註銷; 有效日期: 2026/12/29; 英文品名: Eklira Genuair 322 micrograms Inhalation Powder

Autorisasjon status:

已註銷

Autorisasjon dato:

2016-12-29

Informasjon til brukeren

322
EKLIRA GENUAIR 322 MICROGRAMS INHALATION POWDER
ACLIDINIUM, 322 MICROGRAMS, INHALATION POWDER
026958
1
EKLIRA
®
GENUAIR
®
COPD
2
322 mcg
EKLIRA GENUAIR
3
EKLIRA GENUAIR
delivered dose
375 micrograms
aclidinium bromide
322 micrograms
aclidinium
400 micrograms
aclidinium bromide
metered dose
343 micrograms
aclidinium
lactose monohydrate
4
EKLIRA GENUAIR
5.5
aclidinium bromide
5.5
5
5.1
EKLIRA GENUAIR
COPD
5.2
EKLIRA GENUAIR
EKLIRA GENUAIR
5.3
EKLIRA GENUAIR
[
visual halos
]
5.4
EKLIR
A GENUAIR
5.5
E K L I R A G E N U A I R
anaphylaxis
EKLIRA GENUAIR
6
•
5.2
•
5.3
•
5.4
•
5.5
6.1
3
6
COPD
EKLIRA GENUAIR
3
B
C
6
D
636
EKLIRA GENUAIR
400 mcg
64
40
89
58%
94%
COPD
FEV
1
48%
1
3
6
EKLIRA GENUAIR
1%
1
%
EKLIRA GENUAIR
N=636
N=640
%
%
42 6.6
32 5.0
35 5.5
25 3.9
19 3.0
14 2.2
17 2.7
9 1.4
11 1.7
5 0.8
10 1.6
8 1.2
7 1.1
5 0.8
7 1.1
3 0.5
7 1.1
3 0.5
1%
AV block
40
52
COPD
EKLIRA GENUAIR
3
891
EKLIRA GENUAIR
400 mcg
3
6
6.2
EKLIRA GENUAIR
EKLIRA GENUAIR
7
CYP450
EKLIRA
GENUAIR
12.3
7.1
Methylxanthines
aclidinium bromide
COPD
β
2
methylxanthines
7.2
E K L I R A
GENUAIR
8
8.1
C
aclidinium bromide
EKLIRA
GENUAIR
aclidinium bromide
15
RHDD
5.0 mg/kg/day
aclidinium bromide
AUC
5
RHDD
0.2 mg/kg/day
aclidinium
bromide
AUC
0.2 mg/kg/day
20
RHDD
3.6 mg/kg/day
aclidinium bromide
AUC
1,400
RHDD
150 mg/kg/day
aclidinium
bromide
AUC
3-5%
0%
2,300
RHDD
300 mg/kg/day
aclidinium bromide
AUC
8.2
EKLIRA GENUAIR
EKLIRA GENUAIR
8.3
aclidinium bromide
aclidinium
EKLIRA GENUAIR
EKLIRA GENUAIR
8.4
EKLIRA GENUAIR
COPD
COPD
EKLIRA GENUAIR
8.5
636
COPD
400 mcg
EKLIRA GENUAIR
24
197
60
272
60
70
167
70
EKLIRA GENUAIR
12.3
8.6
EKLIRA GENUAIR
12.3
aclidinium
EKLIRA GENUAIR
8.7
EKLIRA GENUAIR
12.3
10
10.1
EKLIRA GENUAIR
16
6,000 mcg
aclidinium bromide 7.5
RHDD
11
EKLIRA GENUAIR
aclidinium bromide
Aclidinium bromide
EKLIRA GENUAIR
Aclidinium bromide
1-Azoniabicyclo
[
2.2.2
]
octane, 3-
[
hydroxydi-2-thienylacetyl
oxy
]
-1-
3-phenoxypropyl
-, bromide,
3
R
-
O
S
HO
Br
-
O
S
+
N
O
Aclidinium bromide
C
26
H
30
NO
4
S
2
B r
564.56
EKLIRA GENUA