Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2018 Publisher: CSL Behring GmbH, Emil-von-Behring-Strasse 76, 35041 Marburg, Germany
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. |
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 |
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.
CSL Behring GmbH, Emil-von-Behring-Strasse 76, 35041 Marburg, Germany
UK: PL 15036/0031
IE: PA 800/8/1
UK: 07 January 2010 / 17 August 2012
IE: 13 June 2014 / 30 January 2019
| Drug | Countries | |
|---|---|---|
| ALBUREX | Austria, Brazil, Canada, Cyprus, Spain, Finland, France, Ireland, Malta, Netherlands, Poland, Romania, Turkey, United Kingdom |
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