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Clear or slightly opalescent and colourless or pale yellow solution with a pH of 5.0-5.6 and an osmolality of 250-350 mOsm/kg.
One ml contains: Human plasma protein 50 mg (of which at least 96% is immunoglobulin G), with a content of antibodies against cytomegalovirus (CMV) of 100 U*.
*Units of the Paul-Ehrlich-Institut reference preparation.
Each vial with 10 ml contains: 500 mg human plasma protein (of which at least 96% is immunoglobulin G), with a content of antibodies against CMV of 1,000 U.
Each vial with 50 ml contains: 2,500 mg human plasma protein (of which at least 96% is immunoglobulin G), with a content of antibodies against CMV of 5,000 U.
Distribution of the IgG subclasses (approx. values): IgG1 65%, IgG2 30%, IgG3 3%, IgG4 2%.
The immunoglobulin A (IgA) content is limited to ≤2,000 micrograms/ml.
Produced from the plasma of human donors.
Excipients/Inactive Ingredients: Glycine, water for injections.
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