"貝靈" 克凝妥第十三凝血因子注射劑250國際單位

Ülke: Tayvan

Dil: Çince

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

Aktif bileşen:

Human coagulation factor XIII

Mevcut itibaren:

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 kodu:

B02BD07

Farmasötik formu:

凍晶注射劑

Kompozisyon:

Human coagulation factor XIII (2012104000) IU

Paketteki üniteler:

盒裝

Sınıf:

菌　疫

Reçete türü:

限由醫師使用

Tarafından üretildi:

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

Terapötik alanı:

coagulation factor XIII

Terapötik endikasyonlar:

先天性第十三凝血因子缺乏症的預防性治療以及圍手術期(perioperative)出血管理。

Ürün özeti:

有效日期: 2029/06/21; 英文品名: Cluvot 250IU

Yetkilendirme tarihi:

2019-06-21

Bilgilendirme broşürü

“
”
250
CLUVOT 250IU
000027
▼
4.8
1.
Cluvot 250 IU
2.
Cluvot (FXIII)
250 IU
Cluvot 4 ml 62.5 IU/ml (250 IU/4 ml)
Cluvot 6 – 10 IU
7.1
3.
4.
4.1
(peri-
operative)
4.2
1 ml 62.5 IU100 IU 1.6 ml
• 40 IU
• 4 ml
• 28 4
5
20 %
•
±
5 IU
•
Berichrom
®
Berichrom
®
(%)
< 5 %
5
5 % ~ 20 %
> 20 %
5
> 25 %
5
Berichrom
®
• 21
28
－
28
• 8
21
－
Cluvot
• 7
－
70 % -
140 %
/
5.1 5.2
> 65
4 ml
Cluvot
7.6
4.3
7.1
4.4
Cluvot
Cluvot (
)
Cluvot
(CJD)
02-2757-6970
• Cluvot
•
4.5
4.6
Cluvot
Cluvot
Cluvot
Cluvot
Cluvot
4.7
4.8
(
> 1 %)
-
(0.5 %)
12 188 108 16
4314
12
25 16 1 42 2
8
8
23
4
1
10 C
5.
5.1
ATC codeB02B D07
酰
transamidase
activity(lysine)(glutamine)
18 28
Cluvot 5 % 20 %
5.2
Cluvot
6.6
±
2.29
(
±
)
Cluvot
18
-
AUC
ss, 0-inf
(units•hr/mL)
182.9 (133.5-300.2)
C
ss, max
(units/mL)*
0.9 (0.6-1.2)
C
ss, min
(units/mL)*
0.07 (0.0-0.16)
T
max
(hr)
1.2 (0.7-4.2)
Half-life [days]
7.8 (3.1-11.02)
CL [mL/hr/kg]
0.22 (0.13-0.30)
V
ss
[mL/kg]
49.4 (31.65-62.91)
MRT [days]
11.7 (5.7-17.02)
AUC
ss, (0-inf)
= 0
* 1 unit/mL 100%
C
ss, max
C
ss, min
T
max
CL
V
ss
MRT=
188
117
18 (1
2
17 2
12
62 12
16 30 17
18 8 )
PK 2002 14
5 2 18 (2-11
3 12-16
2 17-18
0 )(7.1
±
2.74
0.22
±
0.07 mL/hr/kg)
16
(
5.7
±
1.00 0.291
±
0.12
mL/hr/kg)
5.3
Cluvot
Cluvot
6.
41
28
40 U/kg
52
Cluvot Cluvot
Cluvot
5
2
2
1
2.5
0
52 8 1
8 6
2 1
Cluvot 1
28
5 %
20 % 97 % ≥ 5 %
85 %
≥ 10 % 41
533 28
40 U/kg
5 4
1
4 3 0 7
Cluvot 1 7 Cluvot
Cluvot
50% 1
7.
7.1
(Human Albumin)
(Glucose monohydrate)
(Sodium chloride)
(NaOH) pH
7.2
7.6 Cluvot
7.3
3
≤ 25
°
C 24
4
7.4
(+2
°
C +8
°
C)
7.3
7.5
250 IU
(bromobutyl rubber)
250 IU
1
1 4 ml
1 20/20Mix2Vial
7.6
/
1.
2.
3.
4.
5.
6.
7.
8.
9.
/
4 ml
8.
CSL Behring GmbH
Emil-von-Behring-Strasse 76
35041 Marburg
Germany
9.
1 333 16 (1612 )
022757-6970
10.
2019 7
1
2
3
4
5
6
CLUVOT 250IU
MoHW-Rare -Biologics-Import-Reg. No. 000027
▼
This medicinal product is subject to additional monitoring. This will
allow
quick identification of new safety information. Healthcare
professionals are
asked to