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Therapeutic Octocog alfa recombinant protein from the original Advate® commercial drug.
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ProductBatch | Antigen | Molecular Class | Drug Brand | Product Concentration | CoA | Quantity per vial | Storage Temperature | Expiry Date | Price from | |
|---|---|---|---|---|---|---|---|---|---|---|
Clotting Factor VIII |
Recombinant protein |
Advate® |
125 IU/mL |
– |
25 IU |
-80°C |
2022.09 |
414,90 € |
| Drug name | Advate® |
| INN | Octocog Alffa |
| API type | Octocog alfa (human coagulation factor VIII (rDNA)) is a purified protein that has 2332 amino acids. It is produced by recombinant DNA technology in Chinese hamster ovary (CHO) cells. Prepared without the addition of any (exogenous) human- or animal-derived protein in the cell culture process, purification or final formulation. |
| Pharmacotherapeutic group | Antihemorrhagics, blood coagulation factor VIII |
| ATC code | B02BD02 |
| Target of antibody | TNF alpha |
| General function | Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency). Octocog Alfa is indicated in all age groups. |
| Short description | |
| Pharmacodynamic properties (Mechanism of action; Source EMA document) | When infused into a haemophilia patient, octocog alfa binds to endogenous von Willebrand Factor in the patient’s circulation. Activated factor VIII acts as a Cofactor for activated Factor IX, accelerating the conversion of Factor X to activated Factor X. Activated Factor X converts prothrombin to thrombin. Thrombin then converts fibrinogen into fibrin and a clot can be formed. Haemophilia A is a sex-linked hereditary disorder of blood coagulation due to decreased levels of factor VIII activity and results in profuse bleeding into joints, muscles or internal organs, either spontaneously or as a result of accidental or surgical trauma. The plasma levels of factor VIII are increased by replacement therapy, thereby enabling a temporary correction of the factor VIII deficiency and correction of the bleeding tendency. |
| Pharmacodynamic properties (Pharmacodynamic effects; Source EMA document) | |
| Original license holder | Takeda Manufacturing Austria AG Industriestrasse 67 A-1221 Vienna Austria |
| Marketing authorisation numbers | EU/1/03/271/001 |
| Marketing authorisation holder | Takeda Manufacturing Austria AG Industriestrasse 67 A-1221 Vienna Austria |
| Name of the manufacturer of the biological active substance | Baxalta Manufacturing Sàrl Route de Pierre-à-Bot 111 CH-2000 Neuchâtel Switzerland Baxalta Manufacturing SARL Singapore Branch 2A Woodlands Industrial Park D Street 2 Singapore 737779 Singapore |
| Name and address of the manufacturer(s) responsible for batch release | Baxalta Belgium Manufacturing SA Boulevard René Branquart 80 B-7860 Lessines Belgium |
| Max shelf life | 2 years |
| Storage conditions | 2°C – 8°C |
| List of excipients | Powder: Mannitol, Sodium chloride, Histidine, Trehalose, Calcium chloride, Trometamol, Polysorbate 80, Glutathione (reduced) Solvent: Sterilised water for injections |
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