Active substance: human C1-esterase inhibitor.
Berinert contains 500 IU per injection vial.
The potency of C1-esterase inhibitor is expressed in International Units (IU), which are related to the current WHO Standard for C1-esterase inhibitor products.
Berinert contains 50 IU/ml C1-esterase inhibitor after reconstitution with 10 ml water for injections.
The total protein content of the reconstituted 500 IU solution is 6.5 mg/ml.
Excipients with known effect: Sodium up to 486 mg (approximately 21 mmol) per 100 ml solution.
Excipients/Inactive Ingredients: Powder: Glycine, Sodium chloride, Sodium citrate. Solvent: Water for injections.