"科基"血凝素第八因子注射劑（重組體）

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:

ANTIHEMOPHILIC FACTOR

可用日期:

台灣拜耳股份有限公司 台北市信義區信義路5段7號53樓 (23167184)

ATC代码:

B02BD02

药物剂型:

凍晶注射劑

组成:

ANTIHEMOPHILIC FACTOR (8004000100) IU (I

每包单位数:

小瓶裝;;注射用水針筒裝;;瓶裝;;注射用水針筒裝;;小瓶裝;;瓶裝;;注射用水針筒裝;;包裝;;注射用水針筒裝

类:

菌　疫

处方类型:

限由醫師使用

厂商:

BAYER HEALTHCARE LLC 800 DWIGHT WAY, BERKELEY, CA 94710 USA US

治疗领域:

coagulation factor VIII

疗效迹象:

1.治療Ａ型血友病。2.無關節損傷之A型血友病患童的常規預防。3.常規預防性治療，用以防止或減少在A 型血友病成人中的出血事件發生頻率。

產品總結:

註銷日期: 2023/02/03; 註銷理由: 自請註銷; 有效日期: 2026/03/12; 英文品名: KOGENATE FS, ANTIHEMOPHILIC FACTOR (RECOMBINANT), FORMULATED WITH SUCROSE

授权状态:

已註銷

授权日期:

2001-03-12

资料单张

APPROVED
73
(PTPs)(
100
)
1
72
4
(PUPs)
(MTPs)
60
9
(15%)
6
1
(>5 BU)
3
7
(
2-16
)
Kogenate FS
Joint Outcome Study
5
64
8
(12.5%)
2
(>5 BU)
1
6
44
(
5-151
)
(PUPs)
(
)
Kogenate FS
6.2
Kogenate FS
RODIN
7
(FranceCoag)
8
(UKHCDO)
9
Kogenate
FS
(PUPs)
38% 50% 35%
10
(PUPs)
11
(2005
2012)
(EUHASS)
2009
2013
Kogenate FS
(PUPs)
42% 31%
8
8.1
Kogenate FS
Kogenate FS
Kogenate FS
8.2
Kogenate FS
8.3
Kogenate FS
8.4
13
0-2.5
2.5
16
8.5
Kogenate FS
65
65
Kogenate FS
11
Kogenate FS
(
)
DNA
(Baby Hamster Kidney, BHK)
14
(Human Plasma Protein Solution,
HPPS)
80kD
90kD
Kogenate FS
/
(Transmissible spongiform encephalopathy, TSE)
(vCJD)
(CJD)
15-19
Kogenate FS
3
Kogenate FS
250
500
1000
2000
(IU
)
Kogenate FS
(WHO)
4
Kogenate FS
(
80
tri-n-butyl phosphate
)
(anaphylaxis)
5
5.1
Kogenate FS
Kogenate FS
G (MuIgG)
(BHK)
Kogenate FS
5.2
Kogenate FS
(
inhibitor)
(PUPs)
6
5.3
5.4
‡
‡
Kogenate FS
Bethesda Units (BU)
ƕ
10 BU
Kogenate FS
ƕ
10 BU
Kogenate FS
6
Kogenate FS
(
)
•
(PUPs)
(MTPs)
(
)
(
)
(CVAD)
6.1
73
(PTPs)
24,936
24
•
3
25
(IU)
25
(IU)
5
2.2
Kogenate FS
Kogenate FS
HIV (AIDS)
Kogenate FS
Kogenate FS
15
‡
‡
Kogenate FS
‡
1.
2.
(
37
99
)
3.
(
A)
4.
(
B)
5.
(
C)
6.
(
D)
7.
(
E)
8.
(
F)
9.
(
G)
10.
(
H)
11.
(
I)
12.
(
)
(
J)
13.
(
)
ऋஅ
® ՖᏗશ಑ΤӰυݧৢᏘ(१ಢᡝ)
250 IU/vial, 500 IU/vial, 1000 IU/vial, 2000 IU/vial
KOGENATE
® FS, ANTIHEMOPHILIC FACTOR (RECOMBINANT),
FORMULATED WITH SUCROSE,
250 IU/VIAL, 500 IU/VIAL, 1000 IU/VIAL, 2000 IU/VIAL
ፏဍ຃࣫ᒯԅ಑ 000740, 000642, 000641 ဴ
With
VIAL ADAPTER
1
(IU/DL
%)
20-40
30-60
80-100
(IU/
)
10–20
15–30
Initial:
40–50
Repeat:
20–25
(
)
12–24
8–12
(
)
2
(IU/DL
%)
30-60
100
(IU/
)
15–30
50
100%
(
)
12–24
6-12
(FVIII)
(
)
MedDRA
SOC=
(System Organ Class)
N = 73
(%)
6 (8.2%)
3 (4.1%)
3
(PTPs)
•
(AR) (
12-59
)
MedDRA
SOC =
(System Organ Class)
(
)
N = 61
(%)
10 (16%)
9 (15%)
†
4 (7%)
4
•
(AR)
(
2-27
)
†
N = 60
MedDRA
SOC=
(System Organ Class)
N = 32
(%)
19 (59%)
6 (19%)
1 (3%)
N = 33
(%)
18 (55%)*
6 (18%)
4 (12%)
5