安友凝基因工程第八凝血因子凍晶注射劑500國際單位

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:

LONOCTOCOG ALFA (rVIII-SingleChain)

可用日期:

傑特貝林有限公司 臺北市信義區基隆路1段333號16樓(1612室) (43836487)

ATC代码:

B02BD02

药物剂型:

凍晶乾燥注射劑

组成:

LONOCTOCOG ALFA (rVIII-SingleChain) (2003001000) IU

每包单位数:

玻璃小瓶裝

类:

菌　疫

处方类型:

限由醫師使用

厂商:

AGC BIOLOGICS A/S VANDTAARNSVEJ 83B, DK-2860 SOEBORG, COPENHAGEN, DENMARK DK

治疗领域:

coagulation factor VIII

疗效迹象:

罹患A型血友病(先天性第八凝血因子缺乏症)病人的出血治療及預防

產品總結:

有效日期: 2024/12/11; 英文品名: Afstyla 500IU

授权日期:

2019-12-11

资料单张

250
Afstyla 250 IU
: 001102
500
Afstyla 500 IU
: 001103
1000/2000
Afstyla 1000 IU/ 2000 IU
: 001104
1.
2 5 0
5 0 0
1000
2000
2.
250
250rVIII-SingleChain
lonoctocog alfa2.5100
500
500rVIII-SingleChain
lonoctocog alfa2.5200
1000
1000
rVIII-SingleChain
lonoctocog alfa2.5400
2000
2000rVIII-SingleChain
lonoctocog alfa
5400
(chromogenic assay)
7400 – 16000
CHO
B
(domain)a34
765~1652
N
B
a3
furin
25050010002.5
17.5 0.76
15002000250030005
35 1.52
6.1
3.
6.6 - 7.3
500 – 600
4.
4.1
A
4.2
(coagulation analysis)
aPTT(one-stage clotting assay)
(chromogenic
assay)/
45%
2
IU
IU
(potency assignment)
(chromogenic substrate assay)
(on demand treatment)
1
2/100(IU/dL)
IU
= kg
×
IU/dL%
×
0.5
IU/dLIU/kg
%IU/dL /
%
IU/ DL
/
20 - 40
12
241
30 - 60
12
24
3
4
60 - 100
8
24
30 - 60
241
80 - 100
8
24
7
30%
60% IU/
dL
20
50/
23
12
30
50
2
3
12
125.2
65
10/
6.6
4.3
6.1
4.4
(hypersensitivity reactions)
(hives)(urticarial)
(anaphylaxis)
A
IgG
Bethesda Units
BU
/
50
2
4.2
central venous access device, CVAD
7
0.3
4.5
4.6
A
4.7
4.8
(
)
A
SOC
A
≥1/10≥1/100
<1/10≥1/1,000
<1/100≥1/10,000
<1/1,000
<1/10,000
PTPs*
PUPs
*
* A
PTPs =
PUPs =
(
:02-23960100)
4.9
5.
5.1
ATCB02BD02
lonoctocog alfa
B
VWF
/
A
12 – 65
1001
175 A
1265
1 60
14,306 (EDs)(anaphylactic
reaction)
146 1.14
0.0, 4.279
54% 47
32%
2
3
35 30 /
4,283 /
100184893.5%
34.7/
10011316
18
12
30028412356
49
6
125,239
(EDs)(anaphylactic reaction)
803.69
0.00, 7.204353%2430%
2
3
35
32/
4,109/
300234795.7%
27.6/
ABR
5.2
81
A
<1%18-6050
(
4.2
)3~6
50
–
50
81
%
IR100
2.00 (20.8)
1.99 (0.868, 2.90)
C
max
100
106 (18.1)
106 (62.4, 151)
AUC
0-inf
*100
1960 (33.1)
1910 (932, 4090)
t
12
14.2 (26.0)
13.7 (7.54, 23.9)
MRT
20.4 (25.8)
20.2 (10.8, 35.1)
CL
2.90 (34.4)
2.67 (1.26, 5.79)
V
ss
55.2 (20.8)
53.2 (32.4, 99.6)
IR = 30C
max
=AUC
0-inf
= –
t
1
2
= MRT =
CL =80
V
ss
=IR
C
max
(81)
PK50
101218390
12A<1%
4.2
50
–
06
20
%
612
19
%
1218
10
%
IR
100
1.60 (21.1)
1.55 (1.18, 2.76)
1.66 (19.7)
1.69 (0.92, 2.35)
1.69 (24.8)
1.76 (0.88, 2.44)
C
max
100
80.2 (20.6)
78.6 (59.3, 138)
83.5 (19.