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ALBUREX 20, 200g/l Solution for infusion (2018)

Active ingredients: Albumin

Product Name and Form

Alburex 20, 200 g/l, solution for infusion.

Pharmaceutical form

Solution for infusion.

A clear, slightly viscous liquid; it is almost colourless, yellow, amber or green.

Qualitative and Quantitative Composition

Alburex 20 is a solution containing 200 g/l of total protein of which at least 96% is human albumin.

One vial of 50 ml contains 10 g of human albumin.

One vial of 100 ml contains 20 g of human albumin.

Alburex 20 is hyperoncotic to normal plasma.

Excipient with known effect: Alburex 20 contains approximately 3.2 mg sodium per ml of solution (140 mmol/l).

For the full list of excipients, see section 6.1.

Chemical substance
Description
Albumin

Human albumin accounts quantitatively for more than half of the total protein in the plasma and represents about 10% of the protein synthesis activity of the liver. The most important physiological functions of albumin results from its contribution to oncotic pressure of the blood and transport function. Albumin stabilises circulating blood volume and is a carrier of hormones, enzymes, medicinal products and toxins.

List of 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 litre

Pack sizes and Marketing

50 ml of solution in a single vial (glass type II) with a stopper (halogenated synthetic elastomer).

100 ml of solution in a single vial (glass type II) with a stopper (halogenated synthetic elastomer).

1 vial per pack (10 g/50 ml, 20 g/100 ml).

Not all pack sizes may be marketed.

Marketing authorization holder
Authorization dates

CSL Behring GmbH, Emil-von-Behring-Strasse 76, 35041, Marburg, Germany

UK: 07 January 2010 / 17 August 2012
IE: 13 June 2014 / 30 January 2019

Marketing authorization number:

UK: PL 15036/0032
IE: PA 800/8/2