血甯博皮下注射劑30毫克/毫升

Country: Թայվան

language: չինարեն

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

active_ingredient:

emicizumab

MAH:

台灣中外製藥股份有限公司 台北市松山區敦化北路260號3樓 (23060795)

ATC_code:

B02BX06

pharmaceutical_form:

注射液劑

composition:

emicizumab (2012103500) MG/ML

units_in_package:

盒裝

class:

菌　疫

prescription_type:

限由醫師使用

manufactured_by:

Bushu Pharmaceuticals Ltd. Kawagoe Factory 1 Takeno, Kawagoe, Saitama, 350-0801, Japan JP

therapeutic_area:

emicizumab

therapeutic_indication:

適用於帶有或未帶有第八凝血因子抗體的A型血友病（先天性第八凝血因子缺乏）病人之出血事件常規性預防。

leaflet_short:

有效日期: 2028/08/28; 英文品名: HEMLIBRA SC Injection 30 mg/mL

authorization_date:

2018-08-28

PIL

1.
®
150
/
HEMLIBRA
®
SC Injection 150 mg/mL
®
30
/
HEMLIBRA
®
SC Injection 30 mg/mL
2.
Hemlibra 30 mg/mL
mL
30 mg emicizumab*
1 mL
30 mg emicizumab
30 mg/mL
Hemlibra 150 mg/mL
mL
150 mg emicizumab*
0.4 mL
60 mg emicizumab
150 mg/mL
0.6 mL
90 mg emicizumab
150 mg/mL
0.7 mL
105 mg emicizumab
150 mg/mL
1 mL
150 mg emicizumab
150 mg/mL
* Emicizumab
DNA
CHO
G4 IgG4
6.1
3.
4.
4.1
A
4.2
/
Hemlibra
aPCC
rFVIIa
4.4
Hemlibra
7
FVIII
4
3 mg/kg
1.5 mg/kg
2
3 mg/kg
4
6 mg/kg
/
mg
mL
•
4
3 mg/kg
kg
3 mg/kg =
emicizumab
mg
•
5
1.5 mg/kg
2
3 mg/kg
4
6 mg/
kg
kg
1.53
6 mg/kg =
emicizumab
mg
Hemlibra
emicizumab
mg
mg/mL =
Hemlibra
mL
Hemlibra
30 mg/mL
150 mg/mL
16 kg
1.5 mg/kg
•
4
16 kg
3 mg/kg =
48 mg emicizumab
•
48 mg
150 mg/mL
48 mg emicizumab150 mg/mL =
0.32 mL
150 mg/mL
Hemlibra
•
•
516 kg
1.5 mg/kg =
24 mg
emicizumab
•
24 mg
30 mg/mL
24 mg emicizumab30 mg/mL =
0.8 mL
30 mg/mL
Hemlibra
•
40 kg
2
3 mg/kg
•
440 kg
3 mg/kg =
120 mg
emicizumab
•
120 mg
150 mg/mL
120 mg emicizumab150 mg/mL =
0.8 mL
150 mg/mL
Hemlibra
•
•
540 kg
3 mg/kg =
120 mg
emicizumab
•
120 mg
150 mg/mL
120 mg emicizumab150 mg/mL =
2
0.8 mL
150 mg/mL
Hemlibra
•
5
≥ 1
< 2
55
12
50
12
<18
A
emicizumab
emicizumab
13
65
77
emicizumab
< 65 ≥ 65
emicizumab
A
emicizumab
emicizumab
A
N=332
[
CLcr
]
≥ 90 mL/min
N=27
CLcr
60-89 mL/min
emicizumab
Hemlibra
2
CLcr
30-59 mL/min
emicizumab
Hemlibra
emicizumab
A
AST ≤ ULNN=300
≤ ULN
AST > ULN
1.0
1.5
ULN
AST N=51
6
1.5
ULN <
≤ 3
ULN
AST
emicizumab
4.2
emicizumab
n=4
Hemlibra
Emicizumab
emicizumab
5.3
30 mg/kg/week
AUC
3 mg/kg/week
11
emicizumab
emicizumab
–
/
6.
6.1
L-Arginine
L-Histidine
L-Aspartic acid
Polyoxyethylene 160 polyoxypropylene 30 glycol
6.2
Hemlibra
6.3
2
30 ºC
7
7
30 ºC
7
30 ºC
6.4
2 ºC
8 ºC
6.3
6.5
Hemlibra 30
/
3 mL
1
1 mL
30 mg emicizumab
Hemlibra 150
/
3 mL
1
60 kg
4
6 mg/kg
•
460 kg
3 mg/kg =
180 mg
emicizumab
•
180 mg
150 mg/mL
180 mg emicizumab150 mg/mL =
1.20 mL
150 mg/mL
Hemlibra
•
•
560 kg
6 mg/kg =
360 mg
emicizumab
•
360 mg
150 mg/mL
360