Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050, Bruxelles, Belgium
ReFacto AF 250 IU powder and solvent for solution for injection.
ReFacto AF 500 IU powder and solvent for solution for injection.
ReFacto AF 1000 IU powder and solvent for solution for injection.
ReFacto AF 2000 IU powder and solvent for solution for injection.
ReFacto AF 250 IU powder and solvent for solution for injection in pre-filled syringe.
ReFacto AF 500 IU powder and solvent for solution for injection in pre-filled syringe.
ReFacto AF 1000 IU powder and solvent for solution for injection in pre-filled syringe.
ReFacto AF 2000 IU powder and solvent for solution for injection in pre-filled syringe.
ReFacto AF 3000 IU powder and solvent for solution for injection in pre-filled syringe.
| Pharmaceutical Form |
|---|
|
ReFacto AF 250 IU, 500 IU, 1000 IU, 2000 IU powder and solvent for solution for injection: Powder and solvent for solution for injection. White to off-white cake/powder. Clear, colourless solvent. ReFacto AF 250 IU, 500 IU, 1000 IU, 2000 IU, 3000 IU powder and solvent for solution for injection in pre-filled syringe: Powder and solvent for solution for injection in pre-filled syringe. White to off-white cake/powder in top chamber of the pre-filled syringe. Clear, colourless solvent in bottom chamber of the pre-filled syringe. |
ReFacto AF 250 IU powder and solvent for solution for injection: Each vial contains nominally 250 IU* moroctocog alfa**. After reconstitution, each mL of solution contains approximately 62.5 IU moroctocog alfa.
ReFacto AF 500 IU powder and solvent for solution for injection: Each vial contains nominally 500 IU* moroctocog alfa**. After reconstitution, each mL of solution contains approximately 125 IU moroctocog alfa.
ReFacto AF 1000 IU powder and solvent for solution for injection: Each vial contains nominally 1000 IU* moroctocog alfa**. After reconstitution, each mL of solution contains approximately 250 IU moroctocog alfa.
ReFacto AF 2000 IU powder and solvent for solution for injection: Each vial contains nominally 2000 IU* moroctocog alfa**. After reconstitution, each mL of solution contains approximately 500 IU moroctocog alfa.
ReFacto AF 250 IU powder and solvent for solution for injection in pre-filled syringe: Each pre-filled syringe contains nominally 250 IU* moroctocog alfa**. After reconstitution, each mL of solution contains approximately 62.5 IU moroctocog alfa.
ReFacto AF 500 IU powder and solvent for solution for injection in pre-filled syringe: Each pre-filled syringe contains nominally 500 IU* moroctocog alfa**. After reconstitution, each mL of solution contains approximately 125 IU moroctocog alfa.
ReFacto AF 1000 IU powder and solvent for solution for injection in pre-filled syringe: Each pre-filled syringe contains nominally 1000 IU* moroctocog alfa**. After reconstitution, each mL of solution contains approximately 250 IU moroctocog alfa.
ReFacto AF 2000 IU powder and solvent for solution for injection in pre-filled syringe: Each pre-filled syringe contains nominally 2000 IU* moroctocog alfa**. After reconstitution, each mL of solution contains approximately 500 IU moroctocog alfa.
ReFacto AF 3000 IU powder and solvent for solution for injection in pre-filled syringe: Each pre-filled syringe contains nominally 3000 IU* moroctocog alfa**. After reconstitution, each mL of solution contains approximately 750 IU moroctocog alfa.
* The potency (International Units) is determined using the European Pharmacopoeia chromogenic assay. The specific activity of ReFacto AF is 7,600-13,800 IU/mg protein.
** Human coagulation factor VIII produced by recombinant DNA technology in Chinese hamster ovary (CHO) cells. Moroctocog alfa is a glycoprotein with 1438 amino acids with a sequence that is comparable to the 90 + 80 kDa form of factor VIII (i.e. B-domain deleted) and similar post-translational modifications to those of the plasma-derived molecule.
The manufacturing process for ReFacto was modified to eliminate any exogenous human- or animal-derived protein in the cell culture process, purification, or final formulation; and at the same time the invented name was changed to ReFacto AF.
Excipient with known effect: After reconstitution, 1.23 mmol (29 mg) sodium per vial or pre-filled syringe.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Moroctocog alfa |
Moroctocog alfa is a B-domain deleted recombinant coagulation factor VIII. Moroctocog alfa has functional characteristics comparable to those of endogenous factor VIII. Haemophilia A is a sex-linked hereditary disorder of blood coagulation due to decreased levels of factor VIII:C. By replacement therapy, the plasma levels of factor VIII are increased, thereby enabling a temporary correction of the factor deficiency and correction of the bleeding tendencies. |
| List of Excipients |
|---|
|
Powder: Sucrose Solvent: Sodium chloride |
ReFacto AF 250 IU, 500 IU, 1000 IU, 2000 IU powder and solvent for solution for injection: 250 IU, 500 IU, 1000 IU or 2000 IU powder in a 10 mL vial (type 1 glass) with a stopper (butyl) and a flip-off seal (aluminum) and 4 mL of solvent in a pre-filled syringe (type 1 glass) with a plunger stopper (butyl), a tip-cap (butyl) and a sterile vial adapter reconstitution device, a sterile infusion set, alcohol swabs, a plaster and a gauze pad.
ReFacto AF 250 IU, 500 IU, 1000 IU, 2000 IU, 3000 IU powder and solvent for solution for injection in pre-filled syringe: 250 IU, 500 IU, 1000 IU, 2000 IU or 3000 IU lyophilised powder in top chamber and 4 mL of solvent in bottom chamber of the pre-filled syringe (type 1 glass) with butyl rubber plungers and closure, one plunger rod for assembly, a polypropylene vented sterile cap, a sterile infusion set, alcohol swabs, a plaster and a gauze pad. Pack size of 1.
Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050, Bruxelles, Belgium
EU/1/99/103/001
EU/1/99/103/002
EU/1/99/103/003
EU/1/99/103/004
EU/1/99/103/009
EU/1/99/103/006
EU/1/99/103/007
EU/1/99/103/008
EU/1/99/103/005
Date of first authorisation: 13 April 1999
Date of latest renewal: 15 April 2014
| Drug | Countries | |
|---|---|---|
| REFACTO | Austria, Cyprus, Estonia, Spain, Finland, France, Croatia, Ireland, Italy, Lithuania, Netherlands, New Zealand, Poland, Romania, Tunisia, Turkey, United Kingdom, South Africa |
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
