必凝易得

מדינה: טייוואן

שפה: סינית

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

מרכיב פעיל:

HUMAN PLASMA FRACTION ENRICHED IN BLOOD COAGULATION FACTOR VIII AND HAVING A FACTOR VIII C

זמין מ:

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)

קוד ATC:

B02BD02

טופס פרצבטיות:

凍晶注射劑

הרכב:

HUMAN PLASMA FRACTION ENRICHED IN BLOOD COAGULATION FACTOR VIII AND HAVING A FACTOR VIII C (2012102500) I.U.

יחידות באריזה:

小瓶;;瓶裝注射用水

סיווג:

菌　疫

סוג מרשם:

限由醫師使用

תוצרת:

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

איזור תרפויטי:

coagulation factor VIII

סממני תרפויטית:

先天及後天缺乏第八凝血因子症

leaflet_short:

註銷日期: 2023/07/18; 註銷理由: 自請註銷; 有效日期: 2024/11/21; 英文品名: BERIATE

מצב אישור:

已註銷

תאריך אישור:

2019-08-02

עלון מידע

Packmittel-Bezeichung/
Packaging material
Satzanweisung-Nr./
Drawing no.
Print Services
Entwicklung und Grafik
Graphic arts and typesetting
Packungsbeilage / package insert
Format
755 x 297 mm
755 x 297 mm_1
Maßstab/Scale
1:1
Gezeichnet/Drawn by
E. Baum
Ausgabe-Datum/Date of edition
28.02.2017
gem. PM-Blatt Ausgabe
755
10
Packmittelnummer/ packaging code number
14
95
297
10,33’
95
10,33’
95
10,33’
95
10,33’
95
10,33’
95
95
14
10,33’
5
10
6,1
6,1
50
70
A
20
40 IU
2
3
(
)
4.4
Beriate
(5.1)
6.6
2 ml
Beriate
(4.4)
4.3
6.1
4.4
(
)
A
IgG
Bethesda Units (BU)
factor VIII
20
100
100
(
)
A
4.8
Beriate1000 IU28 mg
/
human immunodeficiency virus (HIV)
hepatitis B virus (HBV)
Hepatitis C virus (HCV)
Hepatitis
A (HAV)Parvovirus B19
(A
B
)
/
Beriate
4.5
4.6
1
2
A
4.7
Beriate
4.8
(
)
()
A
(
)
(≥ 1/10)(≥ 1/100
<1/10)(≥ 1/1,000<1/100)(≥ 1/10,000<1/1,000)
(< 1/10,000)()
3
(polyclonal precipitating antibodies)()(Ouchterlony
assay)
6
6.1
(
)
[
100 mmol/L (2.3 mg/mL)]
2.5 /5.0 /10.0
6.2
6.1
6.3
3
25°C
8
8
(
6.6)
6.4
Beriate
(2°C-8°C)
Beriate
25°C
1
(37ºC)
6.5
(250 IU
500 IU: Type I; 1000 IU: Type II)
Beriate 250 IU
2.5 ml
20/20
Beriate 500 IU
5 ml
20/20
Beriate 1000 IU
10 ml
20/20
6.6
-
Mix2Vial
(
)
()
-
-
4
5
6
7
BERIATE
®
000428
1.
Beriate
®
2.
250 / 500 / 1000 IU(FVIII)
2.5 ml / 5 ml / 10 mlBeriate 250 / 500 / 1000
100 IU/ml
(IU)
(chromogenic)
Beriate
400 IU
6.1
3.
4.
4.1
A()
4.2
International Units (IU)
WHO
(
)
IU (
)
1 ml
1 IU
2.0% (2 IU/dl)
=
×
IU/dl
× 0.5
(IU/dl)
(IU/dl)
20-40
30-60
60-100
30-60
80-100
()
() /()
12-24 1
12-24
1
3-4
8- 24
241
8-24
7
30% -
60% (IU/dl)
/
(IU/dl)
20-40
30-60
60-100
30-60
80-100
()
() /()
12-24
1
12-24
1
3-4
8- 24
24 1
8-24
7
30% -
60% (IU/dl)
/
()
4.4
4.9
5
5.1
ATC codeB02BD02
/von Willebrand factor
(
von Willebrand
factor)
von Willebrand
factor
(prothrombin)
(thrombin)
A
VIII
C
von Willebrand factor
16
6
5.2
522121
IU
(
)
2%
(1.5-3%)
(MRT)
17
(
5.5
)
area under the data
completed by extrapolation (AUDC)0.4 h x kg/ml ( 0.2)
3 ml/h/kg (
1.5 ml/h/kg)
5.3
1
2
3
1.
2.
3.
6