宜譜莎 膜衣錠

Kraj: Tajwan

Język: chiński

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

Składnik aktywny:

Sofosbuvir;;Velpatasvir

Dostępny od:

香港商吉立亞醫藥有限公司台灣分公司 臺北市信義區松仁路32號10樓之1、36號10樓之1 (54376860)

Kod ATC:

J05AP55

Forma farmaceutyczna:

膜衣錠

Skład:

主成分 () ; Sofosbuvir (0818004800) MG; Velpatasvir (0818008000) MG

Sztuk w opakowaniu:

HDPE瓶裝

Klasa:

製　劑

Typ recepty:

須由醫師處方使用

Wyprodukowano przez:

Hovione Ltd. Hovione, Loughbeg, Ringaskiddy, Co. Cork, Ireland IE

Dziedzina terapeutyczna:

sofosbuvir and velpatasvir

Wskazania:

適用於治療12歲以上且體重至少30公斤之兒童與成人病人的慢性C型肝炎病毒 (HCV) 基因型1、2、3、4、5或6之感染症。

Podsumowanie produktu:

有效日期: 2028/12/17; 英文品名: Epclusa Film-Coated Tablets

Data autoryzacji:

2018-12-17

Ulotka dla pacjenta

/
90%
a,b
Epclusa
C
max
AUC
C
min
Omeprazole
20
/sofosbuvir/
velpatasvir
400/100
c
Omeprazole
Epclusa
d
Lansoprazole
e
Rabeprazole
e
Pantoprazole
e
Esomeprazole
e
pH
Sofosbuvir
↓
0.66
0.55,
0.78
↓
0.71
0.60,
0.83
4
Epclusa
omeprazole
20
Velpatasvir
↓
0.63
0.50,
0.78
↓
0.64
0.52,
0.79
Omeprazole
20
/
sofosbuvir/velpatasvir
400/100
c
Epclusa
4
Omeprazole
d
pH
Sofosbuvir
↓
0.79
0.68,
0.92
↔
Velpatasvir
↓
0.67
0.58,
0.78
↓
0.74
0.63,
0.86
Amiodarone
amiodaronevelpatasvir
sofosbuvir
amiodarone
sofosbuvir
Epclusa
4.4
4.8
Digoxin
velpatasvir
↔ Sofosbuvir
Epclusa
digoxin
digoxin
Epclusa
digoxin
Digoxin
0.25
f
/
velpatasvir
100
P-gp
velpatasvir
↔
Velpatasvir
Digoxin
↑
1.9
1.7,
2.1
↑
1.3
1.1,
1.6
Dabigatran etexilate
P-gp
↑ Dabigatran
↔ Sofosbuvir
↔ Velpatasvir
dabigatran
etexilate
Epclusa
dabigatran
K
K
INR
Epclusa
Phenytoin
Phenobarbital
P-gp
CYPs
↓ Sofosbuvir
↓ Velpatasvir
Epclusa
phenobarbital
phenytoin
4.3
Carbamazepine
P-gp
CYPs
↓ Velpatasvir
Epclusa
carbamazepine
4.3
Sofosbuvir
↓
0.52
0.43,
0.62
↓
0.52
0.46,
0.59
Oxcarbazepine
P-gp
CYPs
↓ Sofosbuvir
↓ Velpatasvir
Epclusa
oxcarbazepine
sofosbuvir
velpatasvir
Epclusa
4.4
Ketoconazole
velpatasvir
↔
Sofosbuvir
Epclusa
ketoconazole
Ketoconazole200
/
velpatasvir
100
d
P-gp
CYPs
Itraconazole
e
Voriconazole
e
Posaconazole
e
Isavuconazole
e
ketoconazole
↔
Ketoconazole
Velpatasvir
↑
1.3
1.0,
1.6
↑
1.7
1.4,
2.2
Rifampicin600
/
sofosbuvir
400
d
P-gp
CYPs
rifampicin
↔ Rifampicin
Epclusa
rifampicin
4.3
Sofosbuvir
↓
0.23
0.19,
0.29
↓
0.28
0.24,
0.32
Rifampicin600
/
velpatasvir
100
P-gp
CYPs
rifampicin
↔ Rifampicin
Velpatasvir
↓
0.29
0.23,
0.37
↓
0.18
0.15,
0.22
Rifabutin
P-gp
CYPs
↓ Velpatasvir
Epclusa
rifabutin
4.3
Sofosbuvir
↓
0.64
0.53,
0.77
↓
0.76
0.63,
0.91
Rifapentine
P-gp
CYPs
Sofosbuvir
Velpatasvir
Epclusa
rifapentine
sofosbuvir
velpatasvir
Epclusa
4.4
HIV
酶
Tenofovir disoproxil
fumarate
Epclusa
tenofovir
P-gp
Epclusa
tenofovir disoproxil fumarate/emtricitabine
HIV tenofovir
AUC
C
max
40-80%
tenofovir