奧欣明®膜衣錠10毫克

Land: Taiwan

Språk: kinesiska

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

Aktiva substanser:

Macitentan

Tillgänglig från:

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-kod:

C02KX04

Läkemedelsform:

膜衣錠

Sammansättning:

Macitentan (2412004200) MG

Enheter i paketet:

PVC/PE/PVDC鋁箔盒裝

Klass:

製　劑

Receptbelagda typ:

須由醫師處方使用

Tillverkad av:

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

Terapiområde:

macitentan

Terapeutiska indikationer:

治療肺動脈高血壓(WHO Group I)之成人病患，以延緩疾病惡化。

Produktsammanfattning:

有效日期: 2025/09/10; 英文品名: Opsumit®(CM) film-coated tablets 10 mg

Tillstånd datum:

2015-09-10

Bipacksedel

1
® 10
OPSUMIT
®
(CM)
FILM-COATED TABLETS 10 MG
026536
• OPSUMIT(CM)
(4.1, 5.1, 8.1)
•
1
(2.2, 8.3)
--------------------------------------------------
• (WHO Group 1)
- - - - - - - - - - - - - - - - - - - - - - -
- - - - - - - - - - - - - - - - - - - - - - -
•
• 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(CM)
(7.1, 11.3)
• CYP3A4(ketoconazole
ritonavir)
macitentanOPSUMIT (CM)
(7.2, 11.3)
• CYP3A4
CYP2C9 (fluconazole,
amiodarone)
CYP3A4CYP2C9
macitentan
OPSUMIT(7.3, 12.3)
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
- - - - -
(8.2)
• OPSUMIT(CM)
"
"[4.1]
"
"[5.1]""[8.1]
• 1
1
""[8.3]
1.
(WHO Group 1)
2.
2.1
OPSUMIT(CM)1010
2.2
OPSUMIT(CM)OPSUMIT(CM)
OPSUMIT(CM)
"[4.1]"" [5.2]"" [8.3]
3.
1010
4.
4.1
O P S U M I T ( C M ) O P S U M I T ( C M )
OPSUMIT(CM) OPSUMIT(CM)
"" [5.1]"" [8.1]
5.
5.1
OPSUMIT(CM)
"
"[2.2]
""
[8.18.3]
5.2
ERA(aminotransferases)OPSUMIT(CM)
1
1 SERAPHIN
OPSUMIT(CM) 10
(N=242)
(N=249)
> 3ULN
3.4%
4.5%
> 8ULN
2.1%
0.4%
OPSUMIT(CM)OPSUMIT(CM) 10 mg
3.3%1.6%OPSUMIT(CM)
""[6.2]
> 2
(ULN)OPSUMIT(CM)
OPSUMIT(CM)
5.3
ERAOPSUMIT(CM)
OPSUMIT(CM) 10 mg21.9%
20.5%
ERA
OPSUMIT(CM)
OPSUMIT(CM)
OPSUMIT(CM)
"" [6.2]
OPSUMIT(CM)
OPSUMIT(CM)
OPSUMIT(CM)
5.4
ERAOPSUMIT(CM)
OPSUMIT(CM)
18OPSUMIT(CM) 10 mg 1.0 g/dL
10.0 g/dL OPSUMIT(CM) 10 mg8.7%3.4%
OPSUMIT(CM)
""[6.1]
5.5 (PVOD)
PVOD
OPSUMIT(CM)
5.6
ERA
OPSUMIT(CM)
"" [8.3]"" [12.1]
6.
•
"" [5.1]
•
"" [5.2]
•
"" [5.3]
•
"" [5.4]
6.1
OPSUMIT(CM)742
SERAPHIN
"
" [13]
OPSUMIT(CM)
3.6
54242998
OPSUMIT(CM) 10 mg11%
2 OPSUMIT(CM)
≥3%
2
OPSUMIT(CM) 10
(N=242)
(%)
(N=249)
(%)