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CINRYZE Powder and solvent for solution for injection (2019)

Active ingredients: C1-inhibitor

Product Name and Form

Cinryze 500 IU powder and solvent for solution for injection.

Pharmaceutical form

Powder and solvent for solution for injection.

White powder.

The solvent is a clear, colourless solution.

Qualitative and Quantitative Composition

Each single-use powder vial contains 500 International Units (IU) of C1 inhibitor (human) produced from the plasma of human donors.

After reconstitution, one vial contains 500 IU of C1 inhibitor (human) per 5 ml corresponding to a concentration of 100 IU/ml. One IU is equivalent to the amount of C1 inhibitor present in 1 ml of normal human plasma.

The total protein content of the reconstituted solution is 15 ± 5 mg/ml.

Excipient with known effect: Each vial of Cinryze contains approximately 11.5 mg of sodium.

For the full list of excipients, see section 6.1.

Chemical substance
Description
C1-inhibitor

C1 inhibitor is a single chain glycoprotein found in plasma and a member of the serine protease inhibitor, or serpin, superfamily of proteins. C1 inhibitor inhibits the complement system by binding C1r and C1s and is the most important inhibitor of contact activation, regulating the contact system and the intrinsic coagulation pathway by binding to and inactivating kallikrein and factor XIIa.

List of excipients

Powder:

Sodium chloride
Sucrose
Sodium citrate
L-valine
L-alanine
L-threonine

Solvent:

Water for injections

Pack sizes and Marketing

500 IU of C1 inhibitor in a colourless glass vial (Type I), sealed with a rubber stopper (Type I) and an aluminium seal with a plastic flip-off cap.

5 ml of water for injections in a colourless glass vial (Type I), closed with a rubber stopper (Type I) and an aluminium seal with a plastic flip-off cap.

Each pack contains:

Two powder vials.
Two solvent vials.
2 filter transfer devices, 2 disposable 10 ml syringes, 2 venipuncture sets, and 2 protective mats.

Marketing authorization holder
Authorization dates

Shire Services BVBA, Rue Montoyer 47, B-1000, Brussels, Belgium

Date of first authorisation: 15 June 2011
Date of latest renewal: 26 May 2016

Marketing authorization number:

EU/1/11/688/001