Source: Marketing Authorisation Holder Revision Year: 2021 Publisher: Sanquin Plasma Products B.V., Plesmanlaan 125, NL-1066 CX Amsterdam, The Netherlands
Albuman 200 g/l solution for infusion.
| Pharmaceutical Form |
|---|
|
Solution for infusion. The solution is clear, slightly viscous; it is almost colourless, yellow, amber or green. |
Albuman 200 g/l is a solution containing 200 g/l (20%) of total protein of which at least 95% is human albumin.
A vial contains either 10 g/50 ml or 20 g/100 ml of human albumin.
The solution is hyperoncotic.
Excipient with known effect: This medicinal product contains 100 mmol/l of sodium (2.3 g/l): 115 mg sodium per vial of 50 ml, and 230 mg sodium per vial of 100 ml.
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 caprylate, sodium chloride, sodium hydroxide or hydrochloric acid, water for injections. |
50 ml or 100 ml of solution in a vial (glass type II) with stopper (bromobutyl); pack size of 1.
Not all pack sizes may be marketed.
Sanquin Plasma Products B.V., Plesmanlaan 125, NL-1066 CX Amsterdam, The Netherlands
RVG 103595
Date of first authorisation: 15 June 2009
Date of last renewal: April 15, 2012
| Drug | Countries | |
|---|---|---|
| ALBUMAN | Cyprus, Finland, Hong Kong, Netherlands, Turkey |
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