Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: Swedish Orphan Biovitrum AB (publ), SE-112 76 Stockholm, Sweden
ALTUVOCT 250 IU powder and solvent for solution for injection.
ALTUVOCT 500 IU powder and solvent for solution for injection.
ALTUVOCT 750 IU powder and solvent for solution for injection.
ALTUVOCT 1 000 IU powder and solvent for solution for injection.
ALTUVOCT 2 000 IU powder and solvent for solution for injection.
ALTUVOCT 3 000 IU powder and solvent for solution for injection.
ALTUVOCT 4 000 IU powder and solvent for solution for injection.
| Pharmaceutical Form |
|---|
|
Powder and solvent for solution for injection. Powder: lyophilized, white to off-white powder or cake. Solvent: clear, colourless solution. pH: 6.5 to 7.2. Osmolality: 586 to 688 mOsm/kg. |
ALTUVOCT 250 IU powder and solvent for solution for injection: Each vial contains nominally 250 IU efanesoctocog alfa. ALTUVOCT contains approximately 83 IU/mL of human coagulation factor VIII efanesoctocog alfa after reconstitution.
ALTUVOCT 500 IU powder and solvent for solution for injection: Each vial contains nominally 500 IU efanesoctocog alfa. ALTUVOCT contains approximately 167 IU/mL of human coagulation factor VIII efanesoctocog alfa after reconstitution.
ALTUVOCT 750 IU powder and solvent for solution for injection: Each vial contains nominally 750 IU efanesoctocog alfa. ALTUVOCT contains approximately 250 IU/mL of human coagulation factor VIII efanesoctocog alfa after reconstitution.
ALTUVOCT 1 000 IU powder and solvent for solution for injection: Each vial contains nominally 1 000 IU efanesoctocog alfa. ALTUVOCT contains approximately 333 IU/mL of human coagulation factor VIII efanesoctocog alfa after reconstitution.
ALTUVOCT 2 000 IU powder and solvent for solution for injection: Each vial contains nominally 2 000 IU efanesoctocog alfa. ALTUVOCT contains approximately 667 IU/mL of human coagulation factor VIII efanesoctocog alfa after reconstitution.
ALTUVOCT 3 000 IU powder and solvent for solution for injection: Each vial contains nominally 3 000 IU efanesoctocog alfa. ALTUVOCT contains approximately 1 000 IU/mL of human coagulation factor VIII efanesoctocog alfa after reconstitution.
ALTUVOCT 4 000 IU powder and solvent for solution for injection: Each vial contains nominally 4 000 IU efanesoctocog alfa. ALTUVOCT contains approximately 1 333 IU/mL of human coagulation factor VIII efanesoctocog alfa after reconstitution.
Potency is determined using an activated partial thromboplastin time (aPTT)-based one-stage clotting assay with Actin-FSL reagent.
Efanesoctocog alfa [human coagulation factor VIII (rDNA)] is a protein that has 2 829 amino acids.
Efanesoctocog alfa is produced by recombinant DNA technology in a human embryonic kidney (HEK) cell line. No raw materials of human or animal origin are used in the manufacturing process.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Efanesoctocog alfa |
Efanesoctocog alfa or recombinant coagulation Factor VIII Fc-Von Willebrand Factor-XTEN is a recombinant fusion protein that temporarily replaces the missing coagulation Factor VIII needed for effective haemostasis. |
| List of Excipients |
|---|
|
Powder: Sucrose Solvent: Water for injections |
Each pack of ALTUVOCT 250 IU, 500 IU, 750 IU 1 000 IU, 2 000 IU, 3 000 IU and 4 000 IU powder and solvent for solution for injection contains:
Swedish Orphan Biovitrum AB (publ), SE-112 76 Stockholm, Sweden
EU/1/24/1824/001
EU/1/24/1824/002
EU/1/24/1824/003
EU/1/24/1824/004
EU/1/24/1824/005
EU/1/24/1824/006
EU/1/24/1824/007
© 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.
