Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Octapharma Limited, The Zenith Building, 26 Spring Gardens, Manchester M2 1AB, United Kingdom
GAMMANORM 165 mg/mL solution for injection.
| Pharmaceutical Form |
|---|
|
Solution for injection. The liquid preparation is clear or slightly opalescent and colourless or pale yellow or light-brown. |
Human normal immunoglobulin (SCIg)
One mL contains:
Human normal immunoglobulin 165 mg.
(purity of at least 95% IgG)
Each vial of 6 mL contains: 1 g of human normal immunoglobulin.
Each vial of 10 mL contains: 1.65 g of human normal immunoglobulin.
Each vial of 12 mL contains: 2 g of human normal immunoglobulin.
Each vial of 20 mL contains: 3.3 g of human normal immunoglobulin.
Each vial of 24 mL contains: 4 g of human normal immunoglobulin.
Each vial of 48 mL contains: 8 g of human normal immunoglobulin.
Distribution of the IgG subclasses (approx. values):
IgG1 59%
IgG2 36%
IgG3 4.9%
IgG4 0.5%
The maximum IgA content is 82.5 micrograms/mL
Produced from the plasma of human donors.
Excipient(s) with known effects:
This medicinal product contains 25 mg (or 1.1 mmol) sodium per vial of 10 mL, and 60 mg (or 2.61 mmol) sodium per vial of 24 mL.
For the full list of excipients, see section 6.1.
| 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 |
6 mL, 10 mL, 12 mL, 20 mL, 24 mL or 48 mL of solution in a vial (Type I glass) with a stopper (bromobutyl rubber) - pack size of 1, 10 or 20.
Not all pack sizes may be marketed.
Octapharma Limited, The Zenith Building, 26 Spring Gardens, Manchester M2 1AB, United Kingdom
PL 10673/0029
Date of first authorisation: 31 May 1973
Date of latest renewal: 10 April 2008
| Drug | Countries | |
|---|---|---|
| GAMMANORM | Austria, Brazil, Ecuador, Estonia, Finland, France, Croatia, Ireland, Lithuania, Malta, Netherlands, New Zealand, Poland, Romania, United Kingdom |
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