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Human cytomegalovirus immunoglobulin (CMVIG).
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.
pH of 5.0-5.6 and osmolality of 250-350 mOsm/kg.
Excipients/Inactive Ingredients: Glycine, water for injections.
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