ALBUNORM Solution for infusion Ref.[27722] Active ingredients: Albumin

Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2020 Publisher: Octapharma Ltd., The Zenith Building, 26 Spring Gardens, Manchester M2 1AB, United Kingdom

Product name and form

Albunorm 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

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

A bottle of 100 ml contains 5 g of human albumin.

A bottle of 250 ml contains 12.5 g of human albumin.

A bottle of 500 ml contains 25 g of human albumin.

Albunorm 5% is a mildly hypooncotic solution.

Excipients with known effect:

Sodium (144-160 mmol/l)

For a 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 chloride 7.7. g/l N-acetyl-DL-tryptophan 1 g/l Caprylic acid 0.6 g/l Water for injections ad 1000 ml Electrolytes: Sodium 144-160 mmol/l

Pack sizes and marketing

100 ml of solution in infusion bottle (type II glass) with stopper (bromobutyl rubber).

Pack size of 1 or 10.

250 ml of solution in infusion bottle (type II glass) with stopper (bromobutyl rubber).

Pack size of 1 or 10.

500 ml of solution in infusion bottle (type II glass) with stopper (bromobutyl rubber).

Pack of 1.

Not all pack sizes may be marketed in all countries.

Marketing authorization holder

Octapharma Ltd., The Zenith Building, 26 Spring Gardens, Manchester M2 1AB, United Kingdom

Marketing authorization dates and numbers

PL 10673/0030

19/01/2014

Drugs

Drug	Countries
ALBUNORM	Austria, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Lithuania, Malta, Poland, Romania, Singapore, Tunisia, United Kingdom

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