"愛瑞"人類血清白蛋白25%注射液

País: Taiwán

Idioma: chino

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

Ingredientes activos:

HUMAN ALBUMIN

Disponible desde:

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)

Código ATC:

B05AA01

formulario farmacéutico:

注射液劑

Composición:

HUMAN ALBUMIN (1600000150) (human plasma protein with at least 95% albumin)G/L

Unidades en paquete:

玻璃小瓶裝

clase:

菌　疫

tipo de receta:

限由醫師使用

Fabricado por:

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

Área terapéutica:

albumin

indicaciones terapéuticas:

低蛋白血症、休克、燒傷。

Resumen del producto:

有效日期: 2029/08/12; 英文品名: AlbuRx TM 25

Fecha de autorización:

2014-08-12

Información para el usuario

Sodium N- acetyltryptophanate 20 mmol/l
Sodium caprylate 20 mmol/l
Sodium chloride 140 mmol/l
1
250/95
AlbuRx 25
AlbuRx 25
AlbuRx 253.2(140 mmol/l)
/
(Paediatric population)
(0-18)
1
2
3
4
5
AlbuRx 25
5
0.9
1-2/
“
”
25%
ALBURX™ 25 000960
hemorrhagic diathesis
anuria
250
/
4
200-250
/
40-50
/
AlbuRx 253.2(140 mmol/l)
AlbuRx 25
AlbuRx 25
AlbuRx 25
ATCB05AA01
50
10
4-5
/
40
-
4555-60
19
2
10
AlbuRx 25
3
AlbuRx 25
EXP
AlbuRx 25
30°C
AlbuRx 25
5
0.9
AlbuRx 25Type II
12.5 / 50
25 / 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
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P
COMPOSITION
_A. ACTIVE SUBSTANCE_
Human albumin
_B. EXCIPIENTS_
Sodium N-acetyltryptophanate 20 mmol/l
Sodium caprylate 20 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 250 g/l of human plasma protein, of which at
least 95%
is human albumin.
AlbuRx 25 is an almost colourless, yellow, amber, or green solution
for infusion.
AlbuRx 25 is hyperoncotic to normal plasma.
AlbuRx 25 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