貝樂克口服液劑0.05毫克/毫升

Quốc gia: Đài Loan

Ngôn ngữ: Tiếng Trung

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

Thành phần hoạt chất:

ENTECAVIR

Sẵn có từ:

台灣必治妥施貴寶股份有限公司 台北市松山區健康路156號5樓 (11922609)

Mã ATC:

J05AF10

Dạng dược phẩm:

內服液劑

Thành phần:

ENTECAVIR (0818003100) MG

Các đơn vị trong gói:

塑膠瓶裝

Lớp học:

製　劑

Loại thuốc theo toa:

須由醫師處方使用

Sản xuất bởi:

AstraZeneca Pharmaceuticals LP 4601 HIGHWAY 62 EAST, MOUNT VERNON, INDIANA 47620 USA US

Khu trị liệu:

entecavir

Chỉ dẫn điều trị:

治療有B 型肝炎病毒複製跡象之成人及2 歲以上兒童之慢性B 型肝炎患者。

Tóm tắt sản phẩm:

註銷日期: 2022/07/12; 註銷理由: 未展延而逾期者; 有效日期: 2021/06/22; 英文品名: Baraclude Oral Solution 0.05 mg/mL

Tình trạng ủy quyền:

已註銷

Ngày ủy quyền:

2006-06-22

Tờ rơi thông tin

0.5
024469
1
024468
0.05
/
024467
0.05
/
BARACLUDE
10
0.5
20mL
1
entecavir
4
5
5.1
B
B
(
entecavir
)
B
[
(6.1)
]
B
B
5.2
B
BARACLUDE
HIV/HBV
HIV
HIV (
)
BARACLUDE
B
HIV
[
(12.4)
]
BARACLUDE
/B
HARRT
BARACLUDE
HIV
BARACLUDE
HIV
5.3
(
BARACLUDE)
BARACLUDE
(
)
BARACLUDE
6
[
,
(5.1)
]
[
(5.3)
]
6.1
(AI463014
AI463022
AI463026
AI463027)
1720
BARACLUDE 0.5
mg/
(n = 679)
BARACLUDE 1 mg/
(n = 183)
lamivudine (n = 858)
2
B
AI463022
AI463027
BARACLUDE
69
lamivudine
63
AI463026
AI463014
BARACLUDE
73
lamivudine
51
BARACLUD
E
lamivudine
BARACLUDE
(≥3%)
lamivudine
1%
BARACLUDE
4%
lamivudine
3
BARACLUDE
lamivudine
-
3
2
ENTECAVIR
-
(
2
4)
A
B
LAMIVUDINE
C
/
BARACLUDE
0.5 mg
n=679
Lamivudine
100 mg
n=668
BARACLUDE
1 mg
n=183
Lamivudine
100 mg
n=190
15%
18%
22%
23%
2
4
a
<1%
0
1%
0
<1%
<1%
1%
0
<1%
<1%
<1%
2%
<1%
<1%
<1%
0
1%
1%
3%
3%
2%
2%
4%
1%
<1%
<1%
0
1%
<1%
<1%
0
0
<1%
<1%
0
<1%
a
b
AI463022
AI463027
c
AI463026
AI463014
BARACLUDE 1 mg
lamivudine
A1463014
lamivudine
BARACLUDE
(0.1
0.5
1 mg)
lamivudine 100 mg
52
4
BARACLUDE
lamivudine
4
2
ENTECAVIR
A
B
LAMIVUDINE
C
BARACLUDE
0.5 MG
N=679
LAMIVUDINE
100 MG
N=668
BARACLUDE
1 MG
N=183
LAMIVUDINE
100 MG
N=190
35%
36%
37%
45%
2%
4%
2%
11%
11%
16%
12%
24%
<1%
<1%
0
2%
2%
2%
3%
2%
7%
6%
7%
7%
0
0
0
0
1%
1%
2%
1%
2%
1%
3%
1%
4%
3%
4%
6%
9%
10%
9%
6%
3
4
d
ALT
> 10 x ULN
> 2 x
ALT
> 5.0 x ULN
< 2.5 g/dL
>2.5 x ULN
≥ 2.1 x ULN
> 3.0 x ULN
≥ 0.5 mg/dL
> 250 mg/dL
e
f
< 50,000/mm3
<1%
<1%
<1%
<1%
a
(
<2.5 g/dL)
≥ 0.5 mg/dL
ALT
>10 x ULN
>2 x
b
AI463022
AI463027
HBV
0.015 mg/kg (
0.5
)
0.03 mg/kg (
1
)
BARACLUDE
AI463189 (
)
[
(1)
(2.3)
(6.2)
(12.3)
(14.2)
]
lamivudine
BARACLUDE
B
BARACLUDE
[
(12.4)
]
2
BARACLUDE
BARACLUDE
HBV
8.5
BARACLUDE
65
Entecavir
[
(2.4)
]
8.6
/
Entecavir
8.7
<50 mL/min
CAPD
BARACLUDE
[
(2.4)
(12.3)
]
8.8
65
B
(HBV)
BARACLUDE
HBV
(DNA)
172 IU/mL (
1000 copies/mL)
BARACLUDE 1 mg
(
B
)
82%
39%
37%
49
89%
HBeAg
65
4
BARACLUDE
4
(2
1
1
)
BARACLUDE
4
61
60
B
53
(
65
82%)
72
HBV DNA
53
HBV DNA
<50
IU/
(
300 copies/
)
8
72
HBV DNA
3
BARACLUDE (
B
)
HBV DNA
≥50 I