里先安膜衣錠60毫克

מדינה: טייוואן

שפה: סינית

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

מרכיב פעיל:

Edoxaban Tosilate

זמין מ:

台灣第一三共股份有限公司 台北市中山區松江路223號13樓 (44884303)

קוד ATC:

B01AF03

טופס פרצבטיות:

膜衣錠

הרכב:

Edoxaban Tosilate (9200081910) (as edoxaban free base.........60 MG)MG

יחידות באריזה:

鋁箔盒裝

סיווג:

製　劑

סוג מרשם:

須由醫師處方使用

תוצרת:

DAIICHI SANKYO EUROPE GMBH ZIELSTATTSTRABE 48, 81379 MUNICH, GERMANY DE

איזור תרפויטי:

edoxaban

סממני תרפויטית:

1. 預防非瓣膜性心房纖維顫動(Non-Valvular Atrial Fibrillation； NVAF)合併以下至少一項危險因子之病患發生中風及全身性栓塞(systemic embolism)。危險因子包括：鬱血性心臟衰竭、高血壓、年齡≧75歲、糖尿病、先前曾發生中風或暫時性腦缺血(transient ischemic attack； TIA)。2. 在初始5到10日的非經腸道抗凝血藥物治療後，Lixiana可用於治療靜脈栓塞(Venous thromboembolism； VTE)。靜脈栓塞包括深層靜脈栓塞(Deep Vein Thrombosis； DVT)及肺栓塞(Pulmonary Embolism； PE)。

leaflet_short:

有效日期: 2026/02/02; 英文品名: Lixiana F.C.Tablets 60mg

תאריך אישור:

2016-02-02

עלון מידע

1.
®
15
®
30
®
60
2.
153060edoxaban
6.1
3.
(5.2)
● Lixiana
®
(CrCl)
(CrCl 15–50/(30)CrCl >50/(60)) (
4.4)
● ()
Lixiana
®
Cockcroft-Gault
(CrCl/)
● µmol/L
1.23 × (140-[]) × [] (0.85)
[µmol/L]
● /
(140-[]) × [] (0.85)
72 × [/]
Lixiana
®
CrCl
(CrCl > 50 - 80/)Lixiana
®
60
(CrCl
15 - 50/
)
Lixiana
®
30(
5.2
)
(ESRD)(CrCl < 15/)Lixiana
®
(4.45.2)
Lixiana
®
(4.3)
Lixiana
®
(4.45.2)
Lixiana
®
60(
5.2
)
Lixiana
®
(4.4)
(alanine aminotransferase (ALT)aspartate transaminase (AST) >2 x ULN)
≥1.5 x ULNLixiana
®
(4.45.2)Lixiana
®
≤ 60Lixiana
®
30(5.2)
(5.2)
LIXIANA
®
P(P-GP)
Lixiana
®
P
(P-gp)cyclosporine
dronedarone
erythromycin
ketoconazoleLixiana
®
30(4.5)
amiodarone
quinidine
verapamil
(4.5)
Lixiana
®
P(P-gp)(HIV)
18Lixiana
®
(CARDIOVERSION)
Lixiana
®
(TEE)Lixiana
®
2
(5.15.2) Lixiana
®
12
Lixiana
®
Lixiana
®
(5.2)
Lixiana
®
(
5.2
)
Lixiana
®
(
5.2
)
Lixiana
®
4
(acetylsalicylic acid; ASA)
P2Y
12
(selective serotonin reuptake
inhibitors; SSRIs)(serotonin norepinephrine reuptake inhibitors;
SNRIs)
(nonsteroidal anti-inflammatory drugs; NSAID) (
4.5)
Lixiana
®
3
Lixiana
®
Lixiana
®
Lixiana
®
Lixiana
®
/VTE
(ANTIPHOSPHOLIPID SYNDROMEAPLS)
direct acting oral anticoagulants (DOACs)
edoxabanK
3
lupus anticoagulant
anticardiolipin
antibodiesanti-beta 2-glycoprotein I antibodies
DOACs
Lixiana
®
Xa(anti-FXa)
(5.2)
Lixiana
®
Xa(Factor Xa; FXa)(PT)
INR
(aPTT)
Lixiana
®
4.5
Lixiana
®
(GI)
Lixiana
®
P(P-GP)
Lixiana
®
P(P-gp)Lixiana
®
cyclosporine
dronedarone
erythromycin
ketoconazole
quinidine
verapamil
P(P-gp)
Lixiana
®
Lixiana
®
cyclosporine
dronedarone
erythromycin
ketoconazole
30(4.2)
Lixiana
®
quinidine
verapamil
amiodarone
(4.2)
Lixiana
®
P(P-gp)human immunodeficiency virus (HIV)
P(P-gp)Lixiana
®
30
● Cyclosporinecyclosporine 500Lixiana
®
60Lixiana
®
AUC
maximum serum concerntration (C
max
)73%74%
● Dronedaronedronedarone 4007
5
Lixiana
®
60
Lixiana
®
AUCC
max
85%46%
● Erythromycinerythromycin 5008
7
Lixiana
®
60
Lixiana
®
AUCC
max
85%68%
● Ketoconaz