傲朴舒膜衣錠10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:

Macitentan

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:

C02KX04

药物剂型:

膜衣錠

组成:

Macitentan (2412004200) MG

每包单位数:

PVC/PE/PVDC鋁箔盒裝

类:

製　劑

处方类型:

須由醫師處方使用

厂商:

PATHEON FRANCE 40 BOULEVARD DE CHAMPARET, 38300 BOURGOIN JALLIEU, FRANCE. FR

治疗领域:

macitentan

疗效迹象:

原發性肺動脈高血壓

產品總結:

有效日期: 2026/01/25; 英文品名: Opsumit film-coated tablets 10mg

授权日期:

2016-01-25

资料单张

1
•
OPSUMIT (4.1, 5.1, 8.1)
• 1 (2.2, 8.3)
--------------------------------------------------
- - - - - - - - - - - - - - - - - - - - - - -
- - - - - - - - - - - - - - - - - - - - - - -
•
• 10
10
(2.1)
--------------------------------------------
• 10 (3)
----------------------------------------------------
• (4.1)
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
- - -
• ERA
(5.2)
• (5.3)
• (5.4)
•
(5.5)
• ERA (5.6)
- - - - - - - - - - - - - - - - - - - - - - -
- - - - - - - - - - - - - - - - - - - - - - -
≥ 3%
/
(6.1)
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
- - - - -
• CYP3A4 (rifampin) macitentan
OPSUMIT
(7.1, 11.3)
• CYP3A4 (ketoconazole
ritonavir)
macitentan OPSUMIT
(7.2, 11.3)
• CYP3A4
CYP2C9 (fluconazole,
amiodarone)
CYP3A4CYP2C9
macitentan
OPSUMIT(7.3, 12.3)
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
- - - - -
(8.2)
• OPSUMIT
"
"[4.1]
""[5.1]
""[8.1]
• 1
1
""[8.3]
1
2
2.1
OPSUMIT 10
10
2.2
OPSUMIT
OPSUMIT
OPSUMIT
"
[4.1]
"
" [5.2]""[8.3]
3
10 10
4
4.1
OPSUMITOPSUMIT
OPSUMIT
OPSUMIT
""[5.1] ""[8.1]
5.
5.1
OPSUMIT
"
"[2.2]
""[8.1
8.3]
5.2
ERA (aminotransferases) OPSUMIT
1 1
SERAPHIN
OPSUMIT 10
(N=242)
(N=249)
> 3 ULN
3.4 %
4.5 %
> 8 ULN
2.1 %
0.4 %
OPSUMIT OPSUMIT 10 mg 3.3%
1.6% OPSUMIT
"
"[6.2]
> 2
(ULN) OPSUMIT
OPSUMIT
5.3
ERA OPSUMIT
OPSUMIT 10 mg 21.9% 20.5%
ERA
OPSUMIT
OPSUMIT
OPSUMIT
""[6.2]
OPSUMIT
OPSUMIT OPSUMIT
5.4
ERA OPSUMIT
OPSUMIT
18 OPSUMIT 10 mg 1.0 g/dL
10.0 g/dL OPSUMIT 10mg 8.7% 3.4%
OPSUMIT
""[6.1]
5.5 (PVOD)
PVOD
OPSUMIT
5.6
ERA
OPSUMIT
"
"[8.3]""[12.1]
6
•
"" [5.1]
•
"" [5.2]
•
"" [5.3]
•
"" [5.4]
6.1
OPSUMIT
742
SERAPHIN
"
" [13]
OPSUMIT 3.6
( 542 429 98 )
OPSUMIT 10 mg 11% 2
OPSUMIT ≥ 3% 2
OPSUMIT 10
(N=242)
(%)
(N=249)
(%)
13
3
/
20
13
12
6
14
9
6
2
9
6
6.2
OPSUMIT
OPSUMIT (ALT, AST)
""[5.2]
/
OPSUMIT
"
"
[5.3]
7
7.1 CYP3A4
CYP3A4 rifampin macitentan OPSUMIT
CYP3A4
"" [11.3]
7.2 CYP3A4
CYP3A4
ketoconazole macitentan HIV
ritonavir CYP3A4 OPSUMIT CYP3A4
"
"
[11.3]