Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: Baxalta Innovations GmbH, Industriestrasse 67, A-1221, Vienna, Austria
ADYNOVI 250 IU/5 ml powder and solvent for solution for injection.
ADYNOVI 500 IU/5 ml powder and solvent for solution for injection.
ADYNOVI 1000 IU/5 ml powder and solvent for solution for injection.
ADYNOVI 2000 IU/5 ml powder and solvent for solution for injection.
| Pharmaceutical Form |
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Powder and solvent for solution for injection. Powder: White to off-white friable powder. |
ADYNOVI 250 IU/5 ml powder and solvent for solution for injection: Each vial contains nominally 250 IU human coagulation factor VIII (rDNA), rurioctocog alfa pegol, corresponding to a concentration of 50 IU/ml after reconstitution with 5 ml solvent.
ADYNOVI 500 IU/5 ml powder and solvent for solution for injection: Each vial contains nominally 500 IU human coagulation factor VIII (rDNA), rurioctocog alfa pegol, corresponding to a concentration of 100 IU/ml after reconstitution with 5 ml solvent.
ADYNOVI 1000 IU/5 ml powder and solvent for solution for injection: Each vial contains nominally 1000 IU human coagulation factor VIII (rDNA), rurioctocog alfa pegol, corresponding to a concentration of 200 IU/ml after reconstitution with 5 ml solvent.
ADYNOVI 2000 IU/5 ml powder and solvent for solution for injection: Each vial contains nominally 2000 IU human coagulation factor VIII (rDNA), rurioctocog alfa pegol, corresponding to a concentration of 400 IU/ml after reconstitution with 5 ml solvent.
The potency (International Units) is determined using the chromogenic assay. The specific activity of ADYNOVI is approximately 4000-6500 IU/mg protein.
The active substance rurioctocog alfa pegol is a covalent conjugate of the protein octocog alfa* with a 20 kDa polyethylene glycol (PEG).
* Human factor VIII produced by recombinant DNA technology in a Chinese Hamster Ovary (CHO) cell line.
Excipient(s) with known effect: Each powder vial contains 0.45 mmol (10 mg) sodium, see section 4.4.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Rurioctocog alfa pegol |
Rurioctocog alfa pegol, is a pegylated recombinant human factor VIII with an extended half-life. Rurioctocog alfa pegol is a covalent conjugate of octocog alfa consisting of 2,332 amino acids with polyethylene glycol (PEG) reagent (MW 20 kDa). The therapeutic activity of rurioctocog alfa pegol is derived from octocog alfa, which is produced by recombinant DNA technology from a Chinese hamster ovary cell line. Octocog alfa is then covalently conjugated with the PEG reagent. The PEG moiety is conjugated to octocog alfa to increase the plasma half-life. |
| List of Excipients |
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Powder: Mannitol Solvent: Sterilised water for injections |
Type I glass vial, closed with a chlorobutyl rubber stopper, containing 250 IU, 500 IU, 1000 IU or 2000 IU of powder.
Type I glass vial, closed with a chlorobutyl rubber stopper, containing 5 ml of sterilised water for injections.
The medicinal product is provided in one of the following configurations:
Baxalta Innovations GmbH, Industriestrasse 67, A-1221, Vienna, Austria
EU/1/17/1247/003
EU/1/17/1247/004
EU/1/17/1247/007
EU/1/17/1247/008
EU/1/17/1247/011
EU/1/17/1247/012
EU/1/17/1247/013
EU/1/17/1247/014
Date of first authorisation: 08 January 2018
| Drug | Countries | |
|---|---|---|
| ADYNOVI | Austria, Cyprus, Estonia, Spain, Finland, France, Croatia, Ireland, Lithuania, Netherlands, Poland, Romania, United Kingdom |
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