"貝靈寧"第九凝血因子注射劑

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:

FACTOR IX

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:

B02BD04

药物剂型:

注射劑

组成:

FACTOR IX (2012100700) 120IU (I

每包单位数:

小瓶裝;;

类:

菌　疫

处方类型:

限由醫師使用

厂商:

CSL BEHRING GMBH EMIL-VON-BEHRING STRASSE 76,35041 MARBURG GERMANY DE

治疗领域:

coagulation factor IX

疗效迹象:

預防及治療B型血友病(先天性第九凝血因子缺乏症)患者之出血。

產品總結:

註銷日期: 2019/10/05; 註銷理由: 自請註銷; 有效日期: 2020/10/23; 英文品名: BERININ P (BLOOD COAGULATION FACTOR IX,HUMAN PASTEURIZED)

授权状态:

已註銷

授权日期:

2000-10-23

资料单张

10
270
5
10
1
Packmittelnr. / packaging code number
Packmittel-Bezeichung/
Packaging material
Packungsbeilage / package insert
800 x 270 · 1
(Code G123)
Gezeichnet/Drawn by
Ausgabe-Datum/
Date of edition
Format
Maßstab/Scale
E. Baum
13.11.2012
800 x 270 mm
1 : 1
gem. PM-Blatt Ausgabe
Satzanweisung-Nr./
Drawing no.
Print Services
Entwicklung und Grafik
Graphic arts and typesetting
90
15
90
800
5
5
5
5
Pharmacode
1.
“”
BERININ
® P
(Blood coagulation Factor IX, human pasteurized)
2.
600/1200 IU
5/10 ml
120 IU/ml
(IU)
(one stage clotting assay)
Berinin P50 IU
167 mmol/l (3.84 mg/ml)
6.1
3.
/
4.
4.1
B()
4.2
(
)
(IU)
(WHO)
(
)
(
)
(IU)1 mL
(IU)
1%
=() × (%IU/dl) × 1.0
(%IU/dl)
•
•
•
•
B
20
40
IU
3
4
4.4
6.6
2 ml
(
4.4)
(CVAD)
CVAD
/
human immunodeficiency virus
(HIV)hepatitis B virus (HBV)hepatitis C virus (HCV)
hepatitis A virus (HAV)
B19 (parvovirus B19)
B19
B19
(
)
()
(A
B
)
/
4.5
(
)
(
)
(4.4)
B
(
)
(HAT
Type II)100,000µl
50
6-14
(
)
(
)
(
)
()
B
4.4
/
4.9
6.
6.1
III
(pH)
5/10
6.2
6.1
6.3
3
≤25
16
8
6.4
2-25
6.5
600 IU10
type I
(
)
()
1200 IU17
type I
(
)
()
5600 IU
6
type I
(
)
(
)
101200 IU
10
type I
(
)
(
)
_Berinin P 600_
5 ml
20/20
_Berinin P 1200_
10ml
20/20
6.6
-
(
)
()
-
(Mix2Vial)
Berinin P
(
3.2)
7.
8. /
9.
20167
10.
CSL Behring GmbH
Emil-von-Behring-Strasse 76
35041 Marburg
Germany
11.
(02) 236130400800-231956
8
7
6
5
4
3
2
1
000618
(%IU/dl)
20-40
30-60
60-100
30-60
80-100
()
/
() / ()
24
1
24
3-4
8
24
24
8
24
7
30%-60%
(IU/dl)
4.3
6.1
4.4
Berinin P2000 IU64 mg
Berinin P
(
)
(Bethesda Unit, BU)
(DIC)
4.6
B
4.7
4.8
Berinin P
(MedDRA)
(≥ 1/10)
(≥ 1/100
<1/10)
(≥ 1/1,000
<1/100)
(≥ 1/10,000
<1/1,000)
(< 1/10,000)
()
()
5.
5.1
/
ATCB02B D04
68,000
K
XIa
/
B
5.2
14
23
(
10
43
)
(IVR)
1.1 (IU/dl)/(IU/kg)
(
0.57
1.69 (IU/dl)/(IU/kg))
(MRT)
27
(
18
40
)
4.5 mL/h/kg (
2.5
12.5 mL/h/kg)
5.3
Berinin P
Berinin P
(
)
1
2
1.
2.
3
4
5
6
3.
4.
5.
6.
7
8
9
7.
8.
9.
(On demand treatment)
()
1. NAME OF THE MEDICINAL PRODUCT
BERININ
® P
(Blood coagulation Factor IX, human pasteurized)
2. QUALITA