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Instruction for use: Aimafix
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Dosage form: Lyophilizate for the preparation of a solution for infusions
Active substance: Antihemophilic factor IX
ATX
B02BD04 Antihemophilic factor IX
Pharmacological group:
Hemostatic agent [Coagulants (including factors of blood coagulation), hemostatics]
Composition and release form
Lyophilizate for solution for infusion 1 fl.
Normal human coagulation factor IX (highly purified double viral inactivation) 200 IU
Auxiliary substances: sodium chloride - 38 mg; Sodium citrate - 14.7 mg; Glycerol 46.3 mg; Heparin - 20 IU; Antithrombin III - less than 0.125 IU / ml
Specific activity of at least 40 IU / mg protein. Does not contain heterogeneous proteins, no thrombogenic activity
In bottles of 5 ml complete with a solvent (water for injection); In vials of 5 ml and sterile apyrogenic equipment for intravenous infusion; In the box 1 set.
Lyophilizate for solution for infusion 1 fl.
Normal human coagulation factor IX (highly purified double viral inactivation) 500 IU; 1000 IU
Auxiliary substances: sodium chloride - 76 mg; Sodium citrate - 29.4 mg; Glycerol 92.6 mg; Heparin - 50 IU; Antithrombin III - less than 0.125 IU / ml
Specific activity of at least 40 IU / mg protein. Does not contain heterogeneous proteins, no thrombogenic activity
In bottles of 10 ml, complete with a solvent (water for injection); In vials of 10 ml and sterile apyrogenic equipment for intravenous infusion; In the box 1 set.
Pharmachologic effect
Mode of action - hemostatic.
Dosing and Administration
- IV, slowly. 1 IU of factor IX / kg of body weight increases the activity of factor IX in plasma by 0.8%.
- Calculation of the required dose of the drug is made by the formula:
- Initial dose: the required dose (IU factor IX) = body weight (kg) × necessary increase in factor IX activity (%) × 1.2. The total dose and frequency of drug administration should be correlated with clinical efficacy in each case.
- Cases of bleeding when the amount of factor IX should not fall below the indicated level of activity in blood plasma (in% of the norm in the corresponding period) is indicated in the table.
Table
| Bleeding | The therapeutically necessary level of factor IX in blood plasma | The period of time during which it is necessary to maintain a therapeutic level of factor IX activity in the blood | |
| Intensity | Type | ||
| Minor | Hemorrhages in the joints | 30% | At least 1 day, depending on the strength of the bleeding |
| Significant | Intramuscular hemorrhage Removal of a tooth Slight head injury Operation of medium gravity Hemorrhages in the oral cavity | 30–50% | 3-4 days or until the wound is fully healed |
| Life threatening | Severe Surgical Interventions Gastrointestinal bleeding Intracranial, intra-abdominal or pleural bleeding, Fractures | 50–75% | Within 7 days, then therapy for the next not less than 7 days |
In some cases (in determining the initial dose), a larger dose may be administered. In cases of prolonged bleeding prophylaxis in patients with severe hemophilia B, doses of 10-25 IU / kg body weight should be applied at intervals of 3-4 days. In the presence of antibodies to factor IX (inhibitors), special therapy is required. Immune tolerance can be achieved by treatment with a factor IX concentrate. It is recommended to enter no more than 100 IU / kg of body weight per day.
- In cases of severe surgical interventions, replacement therapy should be monitored by coagulation analysis (factor IX activity in the patient's blood plasma).
Manufacturer
Kedrion S.p.A., Italy.
A comment
Representation in Russia: Pharma Riace Ltd.
Storage conditions of the drug Aimafix
In the dark place at a temperature of 2-8 ° C.
Keep out of the reach of children.
Shelf life of Aimafix
2 years.
Do not use after the expiry date printed on the package.
