Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Instituto Grifols, S.A., Can Guasc, 2 Parets del Vallès, 08150, Barcelona Spain
Flebogamma DIF 50 mg/ml solution for infusion.
| Pharmaceutical Form |
|---|
|
Solution for infusion. The solution is clear or slightly opalescent and colourless or pale yellow. Flebogamma DIF is isotonic, with an osmolality from 240 to 370 mOsm/kg. |
Human normal immunoglobulin (IVIg).
One ml contains: Human normal immunoglobulin 50 mg (purity of at least 97% of IgG).
Each vial of 10 ml contains: 0.5 g of human normal immunoglobulin.
Each vial of 50 ml contains: 2.5 g of human normal immunoglobulin.
Each vial of 100 ml contains: 5 g of human normal immunoglobulin.
Each vial of 200 ml contains: 10 g of human normal immunoglobulin.
Each vial of 400 ml contains: 20 g of human normal immunoglobulin.
Distribution of the IgG subclasses (approx. values):
IgG1: 66.6%
IgG2: 28.5%
IgG3: 2.7%
IgG4: 2.2%
The maximum IgA content is 50 micrograms/ml.
Produced from the plasma of human donors.
Excipient with known effect: One ml contains 50 mg of D-sorbitol.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Immunoglobulins, normal human, IV |
Human normal immunoglobulin contains mainly immunoglobulin G (IgG) with a broad spectrum of antibodies against infectious agents. The mechanism of action in indications other than replacement therapy is not fully elucidated, but includes immunomodulatory effects. |
| List of Excipients |
|---|
|
D-sorbitol |
10 ml, 50 ml, 100 ml, 200 ml or 400 ml solution in a vial (type II glass) with stopper (chloro-butyl-rubber).
Pack size: 1 vial
Not all pack sizes may be marketed.
Instituto Grifols, S.A., Can Guasc, 2 – Parets del Vallès, 08150, Barcelona – Spain
EU/1/07/404/001-005
Date of first authorisation: 23 August 2007
Date of latest renewal: 24 April 2017
| Drug | Countries | |
|---|---|---|
| FLEBOGAMMA | Austria, Brazil, Cyprus, Ecuador, Estonia, Spain, Finland, France, Croatia, Ireland, Israel, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Turkey, United Kingdom, United States |
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