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1 ml of solution contains: 100 mg human plasma protein with an IgG content of at least 98% (10% solution).
Active substance: Human immunoglobulin for intravenous use (IVIg)*.
Human plasma protein containing at least 98% immunoglobulin G (IgG).
Distribution of the IgG subclasses (average values): IgG1 69%, IgG2 26%, IgG3 3%, IgG4 2%.
The maximum IgA content is 25 micrograms/ml.
*Produced from the plasma of human donors.
The solution is clear to slightly opalescent and colourless to pale yellow. 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].
Excipients/Inactive Ingredients: L-proline, water for injections.
Privigen contains trace amounts of sodium (≤1 mmol/l).
Privigen contains no preservatives.
Privigen contains no carbohydrate stabiliser (e.g. sucrose, maltose).
