"愛瑞"人類血清白蛋白20%注射液

Country: Taiwan

Language: Chinese

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

Active ingredient:

HUMAN ALBUMIN

Available from:

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 code:

B05AA01

Pharmaceutical form:

注射液劑

Composition:

HUMAN ALBUMIN (1600000150) (human plasma protein with at least 96% albumin)G/L

Units in package:

玻璃小瓶裝

Class:

菌　疫

Prescription type:

限由醫師使用

Manufactured by:

CSL BEHRING L.L.C. ROUTE 50 NORTH, 1201 N. KINZIE, BRADLEY, IL 60915, USA US

Therapeutic area:

albumin

Therapeutic indications:

低蛋白血症、休克、燒傷。

Product summary:

有效日期: 2029/08/12; 英文品名: AlbuRx TM 20

Authorization date:

2014-08-12

Patient Information leaflet

Sodium N- acetyltryptophanate 16 mmol/l
Sodium caprylate 16 mmol/l
Sodium chloride 140 mmol/l
1
200/96
AlbuRx 20
AlbuRx 20
AlbuRx 203.2(140 mmol/l)
/
(Paediatric population)
(0-18)
1
2
3
4
5
AlbuRx 20
5
0.9
1-2/
“
”
20%
ALBURX™ 20 000959
hemorrhagic diathesis
(anuria)
200
/
4
200-250
/
40-50
/
AlbuRx 203.2(140 mmol/l)
AlbuRx 20
AlbuRx 20
AlbuRx 20
ATCB05AA01
50
10
4-5
/
40
-
4555-60
19
2
10
AlbuRx 20
3
AlbuRx 20
EXP
AlbuRx 20
30°C
AlbuRx 20
5
0.9
AlbuRx 20Type II
10 / 50
20 / 100
CSL Behring AG
Wankdorfstrasse 10, 3014 Bern, Switzerland
CSL Behring LLC
Route 50 North, 1201N. Kinzie, Bradley, IL 60915, USA
(02) 2361-30400800-231956
201612
AlbuRx
®
CSL Behring AG
A.
B.
Packmittel-Bezeichung/
Packaging material
Satzanweisung-Nr./
Drawing no.
Print Services
Entwicklung und Grafik
Graphic arts and typesetting
Packungsbeilage / package insert
Format
600 x 270 mm
600 x 270 mm
Maßstab/Scale
1:1
Gezeichnet/Drawn by
E. Baum
Ausgabe-Datum/Date of edition
22.08.2012
gem. PM-Blatt Ausgabe
500
10
5
5
5
5
0
9
270
10
Code
30
1
r
e
b
m
u
n
e
d
o
c
g
n
i
g
a
k
c
a
p
/
r
e
m
m
u
n
l
e
t
t
i
m
k
c
a
P
COMPOSITION
_A. ACTIVE SUBSTANCE_
Human albumin
_B. EXCIPIENTS_
Sodium N-acetyltryptophanate 16 mmol/l
Sodium caprylate 16 mmol/l
Sodium chloride q.s. to a sodium content of 140 mmol/l
Water for injections q.s. to 1 l
PHARMACEUTICAL FORM AND ACTIVE SUBSTANCE CONTENT PER UNIT
Solution for infusion for intravenous use.
The solution contains 200 g/l of human plasma protein, of which at
least 96%
is human albumin.
AlbuRx 20 is an almost colourless, yellow, amber, or green solution
for infusion.
AlbuRx 20 is hyperoncotic to normal plasma.
AlbuRx 20 contains approximately 3.2 mg sodium per ml of solution (140
mmol/l).
THERAPEUTIC INDICATIONS
Hypoproteinemia, shock, burns.
DESCRIPTION
Restoration and maintenance of circulating blood volume in cases of
volume
deficiency where the use of a colloid is indicated.
The choice of albumin rather than artificial colloid will depend on
the clinical
situation of the individual patient, based on