拜瑞妥膜衣錠10毫克"義大利"

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:

RIVAROXABAN

可用日期:

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)

ATC代码:

B01AF01

药物剂型:

膜衣錠

组成:

RIVAROXABAN (9200099500) Rivaroxaban micronizedMG

每包单位数:

ALU-PP鋁箔盒裝;;ALU-PVC/PVDC鋁箔盒裝

类:

製　劑

处方类型:

須由醫師處方使用

厂商:

BAYER HEALTHCARE MANUFACTURING SRL. VIA DELLE GROANE, 126, 20024 GARBAGNATE MILANESE, ITALY IT

治疗领域:

rivaroxaban

疗效迹象:

1.用於非瓣膜性心房顫動(non-valvular atrial fibrillation)且有下列至少一項危險因子者成人病患，預防中風及全身性栓塞(systemic embolism)。危險因子例如：心衰竭、高血壓、年齡大於等於75歲、糖尿病、曾發生腦中風或短暫性腦缺血發作(transient ischemic attack)。2.Rivaroxaban用於靜脈血栓高危險群（曾發生有症狀之靜脈血栓症）病患，以預防其於接受下肢重大骨科手術後之靜脈血栓栓塞症(VTE)。3.治療深部靜脈血栓與肺栓塞及預防再發性深部靜脈血栓與肺栓塞。說明：各適應症之用法用量，請參閱「用法用量」欄。

產品總結:

有效日期: 2024/08/26; 英文品名: Xarelto film-coated tablets 10mg "Italy"

授权日期:

2019-08-26

资料单张

86424037
305X906-16864_15923
XARELTO
TAVR
XARELTO
2-
I
RIVAROXABAN
K
VKA
RIVAROXABAN
15MG500NAPROXEN
RIVAROXABAN
500MG ACETYLSALI-
CYLIC
WARFARIN
WARFARININR
2.03.02020WARFARININR
2.03.0 / INR
NEOPLASTIN
INR
12
XA APTT
XARELTO
XA
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HEPTEST
WARFARIN
WARFARIN
PT
APTTXAETP“”
WARFARIN
RIVAROXABAN
C
TROUGH
RIVAROX-
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SSRISNRI
SSRIS
SNRIS
RIVAROXABAN
10
1520
RIVAROXABANMIDAZOLAM
(CYP 3A4)DIGOXIN
(P-)ATORVASTATIN
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OMEPRAZOLE
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/
NAPROXENCLOPIDOGRELENOXAPARIN500
MG
PT
APTT
HEP TEST
®
RIVAROXABAN
/
RIVAROXABAN
(
)
34,859RIVAROXABANIIIRIVAROXABAN
XARELTOIII
CYP 3A4
P-GP
027733
“Italy”
“Italy”
“Italy”
027735
027734
“Italy”
“Italy”
XARELTO
Wafarin
HR (95% CI):
0.88 (0.74, 1.03)
6
5
4
3
2
1
0
0 90 100 270 360 450 540 630 720 810 900
305X906-16864_15923
3ROCKET AF * - 2
3
ROCKET AF
†
§
(GI)¶
#
(ICH)
395 (3.6)
55 (0.5)
36 (0.3)
19 (0.2)
221 (2.0)
27 (0.2)
24 (0.2)
3 (0.0)
386 (3.5)
84 (0.7)
58 (0.5)
26 (0.2)
140 (1.2)
55 (0.5)
42 (0.4)
13 (0.1)
1.04 (0.90, 1.20)
0.67 (0.47, 0.93)
0.63 (0.42, 0.96)
0.74 (0.41, 1.34)
1.61 (1.30, 1.99)
0.50 (0.31, 0.79)
0.58 (0.35, 0.96)
0.23 (0.07, 0.82)
XARELTO
N=7111
N (%/YEAR)
WARFARIN
N=7125
N (%/YEAR)
XARELTO VS. WARFARIN
HR
(95% CI)
: HR =
CI =
CRNM =
*
†
2g/ dL
2
/
§
/
¶
#
3
rivaroxaban
VTE
(
)
DVT
PE
VTE
DVT
PE
VTE
rivaroxaban
VTEDVTPEVTEenoxaparin
Alu-PPAlu-PVC/PVDC
Bayer HealthCare Manufacturing S.r.l.
Via delle Groane,
Xarelto film-coated tablets 10mg / CCDS14/ TW13 / 042019 Italy
Xarelto film-coated tablets 15mg, 20mg / CCDS11 / TW09 / 042019 Italy
(sodium laurilsulfate)
126 – 20024 Garbagnate Milanese (MI), Italy