Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2020 Publisher: Grifols Deutschland GmbH, Colmarer Straße 22, 60528 Frankfurt, Germany, Tel.: +49 69-660 593 100
Gamunex 10%,
100 mg/ml, solution for infusion.
| Pharmaceutical Form |
|---|
|
Solution for infusion. The solution is clear or slightly opalescent and colourless or pale yellow. |
Human normal immunoglobulin (IVIg).
One ml contains: human normal immunoglobulin 100 mg (purity of at least 98% IgG).
Each vial of 10 ml contains: 1 g of human normal immunoglobulin.
Each vial of 50 ml contains: 5 g of human normal immunoglobulin.
Each vial of 100 ml contains: 10 g of human normal immunoglobulin.
Each vial of 200 ml contains: 20 g of human normal immunoglobulin.
Each vial of 400 ml contains: 40 g of human normal immunoglobulin.
Distribution of the IgG subclasses (approx. values):
IgG1 62.8%
IgG2 29.7%
IgG3 4.8%
IgG4 2.7%
The maximum IgA content is 84 micrograms/ml.
Produced from the plasma of human donors.
For a full list of excipients, see section 6.1.
This medicinal product contains less than 1 mmol sodium (23 mg) per single dose (up to a maximum of 2 g/kg), i.e. essentially ‘sodium free’.
| Active Ingredient | Description | |
|---|---|---|
| Human normal immunoglobulin G |
Human normal immunoglobulin contains mainly immunoglobulin G (IgG) with a broad spectrum of antibodies against infectious agents. Human normal immunoglobulin contains the IgG antibodies present in the normal population. It is usually prepared from pooled plasma from not fewer than 1000 donors. |
| List of Excipients |
|---|
|
Glycine |
Solution for intravenous infusion in Type I or II glass vials with chlorobutyl stoppers.
Pack sizes:
One vial of 10 ml contains: 1 g of human normal immunoglobulin.
One vial of 50 ml contains: 5 g of human normal immunoglobulin.
One vial of 100 ml contains: 10 g of human normal immunoglobulin.
One vial of 200 ml contains: 20 g of human normal immunoglobulin.
One vial of 400 ml contains: 40 g of human normal immunoglobulin.
Not all pack sizes may be marketed.
Grifols Deutschland GmbH, Colmarer Straße 22, 60528 Frankfurt, Germany, Tel.: +49 69-660 593 100
PL 29527/0001
Date of the first authorisation: 27.07.2006
Date of last renewal: 10.05.2011
| Drug | Countries | |
|---|---|---|
| GAMUNEX | Austria, Brazil, Canada, Cyprus, Spain, Finland, France, Ireland, Israel, Netherlands, New Zealand, Poland, United Kingdom |
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