1 ml of solution contains 100 mg human plasma protein with an IgG content of at least 98% (10% solution).
Privigen is isotonic, with an osmolality of 320 mOsmol/kg.
The pH value of the ready-to-use solution is 4.6 to 5.0 [4.8].
Active substance: Human immunoglobulin for intravenous use (IVIg)*.
One ml contains Human normal immunoglobulin 100 mg.
(Purity of at least 98% immunoglobulin G (IgG)).
Each vial of 50 ml solution contains 5 g human normal immunoglobulin.
Distribution of the IgG subclasses (average values): IgG1 67.8%; IgG2 28.7%; IgG3 2.3%; IgG4 1.2%.
The maximum IgA content is 25 micrograms/ml.
*Produced from the plasma of human donors.
Excipients/Inactive Ingredients: L-proline, water for injection.
Privigen contains trace amounts of sodium (≤ 1mmol/l).
Privigen contains no preservatives.
Privigen contains no carbohydrate stabiliser (e.g. sucrose, maltose).