ALBUREX 5, 50 g/l Solution for infusion Ref.[27528] Active ingredients: Albumin

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: CSL Behring GmbH, Emil-von-Behring-Strasse 76, 35041 Marburg, Germany

Product name and form

Alburex 5, 50 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 5 is a solution containing 50 g/l of total protein of which at least 96% is human albumin.

One vial of 100 ml contains 5 g of human albumin.
One vial of 250 ml contains 12.5 g of human albumin.
One vial of 500 ml contains 25 g of human albumin.

Alburex 5 is mildly hypooncotic to normal plasma.

Excipient with known effect:

Alburex 5 contains approximately 3.2 mg sodium per ml of solution (140 mmol/l).

For the full list of excipients, see section 6.1.

Active Ingredient 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 4 mmol/l
Sodium caprylate 4 mmol/l
Sodium chloride q.s.to a sodium content of 4 mmol/l
Water for injections q.s.to 1 litre

Pack sizes and marketing

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

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

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

1 vial per pack (5 g/100 ml, 12.5 g/250 ml, 25 g/500 ml).

Not all pack sizes may be marketed.

Marketing authorization holder

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

Marketing authorization dates and numbers

UK: PL 15036/0031

IE: PA 800/8/1

UK: 07 January 2010 / 17 August 2012

IE: 13 June 2014 / 30 January 2019

Drugs

Drug Countries
ALBUREX Austria, Brazil, Canada, Cyprus, Spain, Finland, France, Ireland, Malta, Netherlands, Poland, Romania, Turkey, United Kingdom

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