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| Primary information |
|---|
| ID | 10837 |
| Therapeutic ID | Th1200 |
| Protein Name | Prothrombin complex concentrate |
| Sequence | NA
|
| Molecular Weight | NA |
| Chemical Formula | NA |
| Isoelectric Point | NA |
| Hydrophobicity | NA |
| Melting point | NA |
| Half-life | Factor II - 48-60 hrs; factor VII - 1.5-6 hrs; factor IX - 20-24 hrs and factor X - 24 - 48 hrs. |
| Description | Anti-inhibitor coagulant complex, also known as activated prothrombin complex concentrate (APCC) is a preparation containing precursor and activated forms of blood coagulation factors II, VII, IX, and X derived from pooled human venous plasma. |
| Indication/Disease | For use in hemophilia A and B patients with inhibitors for: 1) control and prevention of bleeding episodes; 2) perioperative management; and 3) Routine prophylaxis to prevent or reduce the frequency of bleeding episodes. |
| Pharmacodynamics | The administration of human prothrombin complex provides an increase in plasma levels of the vitamin K dependent coagulation factors, and can temporarily correct the coagulation defect of patients with deficiency of one or several of these factors. |
| Mechanism of Action | They act by reversal of anticoagulants |
| Toxicity | NA |
| Metabolism | NA |
| Absorption | NA |
| NA |
| Clearance | NA |
| Categories | NA |
| Patents Number | NA |
| Date of Issue | NA |
| Date of Expiry | NA |
| Drug Interaction | NA |
| Target | NA |
| Brand Name | Octaplex |
| Company | Octapharma |
| Brand Description | Octapharma |
| Prescribed For | Treatment of bleeding and perioperative prophylaxis of bleeding in acquired deficiency of the prothrombin complex coagulation factors, such as deficiency caused by treatment with vitamin K antagonists, or in case of overdose of vitamin K antagonists, when rapid correction of the deficiency is required. Treatment of bleeding and perioperative prophylaxis in congenital deficiency of the vitamin K dependent coagulation factors II and X when purified specific coagulation factor product is not available. |
| Chemical Name | NA |
| Formulation | NA |
| Physical Appearance | Powder and solvent for solution |
| Route of Administration | Intravenous |
| Recommended Dosage | The dose will depend on the INR before treatment and the targeted INR. In the following table approximate doses (ml/kg body weight of the reconstituted product) required for normalisation of INR (≤ 1.2 within 1 hour) at different initial INR levels are given |
| Contraindication | In patients with acquired deficiency of the vitamin K dependent coagulation factors (e.g. as induced by treatment with vitamin K antagonists), Octaplex should only be used when rapid correction of prothrombin complex levels is necessary, such as major bleeding or emergency surgery. In other cases, reduction of the dose of the vitamin K antagonist and/or administration of vitamin K is usually sufficient. Patients receiving a vitamin K antagonist may have an underlying hypercoaguable state and infusion of prothrombin complex concentrate may exacerbate this. In congenital deficiency of any of the vitamin K dependent factors, specific coagulation factor product should be used when available. If allergic or anaphylactic-type reactions occur, the infusion should be stopped immediately. In case of shock, standard medical treatment for shock should be implemented. |
| Side Effects | Immune system disorders; General disorders and administration site conditions; Vascular disorders; Nervous system disorders; |
| Useful Link 1 | Link |
| Useful Link 2 | NA |
| Remarks | NA |