Composition, form of production and packaging
Lyophilizate for the preparation of a solution for infusions of white or pale yellow color; the prepared solution is clear or slightly opalescent, colorless or light yellow in color.
1 f.
coagulation factor IX human 200 IU *
Excipients: sodium chloride, sodium citrate, glycine, heparin, antithrombin III.
Solvent: water d / u - 5 ml.
Glass vials (1) complete with a solvent (1 pc.) And sterile pyrogen-free system (10 ml syringe, needle - "butterfly" with catheter, needle-adapter, needle-filter, aseptic adhesive plaster) - cardboard boxes.
Lyophilizate for the preparation of solution for infusions of white or pale yellow color; the prepared solution is clear or slightly opalescent, colorless or light yellow in color.
1 f.
coagulation factor IX human 500 IU *
Excipients: sodium chloride, sodium citrate, glycine, heparin, antithrombin III.
Solvent: water d / u - 10 ml.
Glass vials (1) complete with a solvent (1 pc.) And a sterile pyrogen-free system (10 ml syringe, "butterfly" needle with catheter, needle-adapter, needle-filter, aseptic adhesive plaster) - cardboard boxes.
Lyophilizate for the preparation of solution for infusions of white or pale yellow color; the prepared solution is clear or slightly opalescent, colorless or light yellow in color.
1 f.
coagulation factor IX human 1000 IU *
Excipients: sodium chloride, sodium citrate, glycine, heparin, antithrombin III.
Solvent: water d / u - 10 ml.
Glass vials (1) complete with a solvent (1 pc.) And a sterile pyrogen-free system (10 ml syringe, "butterfly" needle with catheter, needle-adapter, needle-filter, aseptic adhesive plaster) - cardboard boxes.
* - activity is determined in accordance with WHO standards 84/681; specific activity of at least 80 IU / mg protein in the final product.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2011.
PHARMACHOLOGIC EFFECT
Coagulation factor IX, obtained from human blood plasma. It is a single chain of a glycoprotein with a molecular weight of about 68,000 Da.
The blood coagulation factor IX human is a vitamin K-dependent clotting factor, which is synthesized in the liver. The blood coagulation factor IX of the human is activated by the factor IX by the internal coagulation mechanism and by the clotting factor complex VII + tissue factor by an external coagulation mechanism. The activated blood coagulation factor IX in combination with activated blood clotting factor VIII activates the blood coagulation factor X. As a result, prothrombin converts to thrombin. Thrombin then converts fibrinogen into fibrin and thus forms a clot. The activity of the coagulation factor IX was significantly reduced in patients with hemophilia B, and therefore, substitution therapy is necessary.
The introduction of the human coagulation factor IX concentrate, obtained from human blood plasma, in patients with hemophilia B leads to a reduction of 30-60% of the coagulation factor IX activity in the blood.
The blood coagulation factor IX, derived from human blood plasma, is a common constituent of human plasma and acts as an endogenous coagulation factor IX.
PHARMACOKINETICS
T 1/2 factor of blood coagulation IX human lasts from 16 to 30 hours, on average - 24 hours.
INDICATIONS
- Treatment and prevention of hereditary bleeding (hemophilia B) and acquired coagulation factor deficiency IX.
DOSING MODE
The dose and duration of substitution therapy depend on the severity of the disorder of the hemostatic function, the localization and intensity of bleeding, and the clinical manifestations of the disease.
The activity of one unit of the blood coagulation factor IX of the human corresponds to the amount of coagulation factor IX in one ml of normal human blood plasma.
Calculation of the dose of the blood coagulation factor IX of human is based on data obtained empirically: 1 ME of the blood coagulation factor IX of human per kg of body weight increases the activity of the coagulation factor IX in the patient's plasma by 0.8% of the norm.
The initial dose is determined by the following formula:
Required number of units = body weight (kg)? the desired increase in factor IX (%)? 1.2
It is important to take into account that the amount of the drug administered and the frequency of application should always be oriented toward clinical effectiveness in each specific case.
In the following cases of bleeding, the concentration of the coagulation factor IX should not fall below the indicated level of activity in blood plasma (in% of the norm) in the corresponding period:
Type of bleeding Therapeutically necessary level of blood coagulation factor IX in the plasma Period of time during which it is necessary to maintain the therapeutic level of the coagulation factor IX in plasma
Minor bleeding: joint hemorrhages 30% At least 1 day, depending on the strength of the bleeding
Significant bleeding: intramuscular hemorrhage; removal of a tooth; slight head injury; operations of medium gravity; bleeding in the oral cavity 30-50% 3-4 days or until the wound is fully healed
Hemorrhages threatening life: severe surgical interventions; gastrointestinal bleeding; intracranial, intra-abdominal or pleural bleeding; Fractures 50-70% Within 7 days, then therapy for at least the next 7 days
In certain circumstances, especially when determining the initial dose, a more significant dose of the drug may be required than the one calculated above. In particular, in cases of severe surgical interventions, it is necessary to monitor accurately the monitored replacement therapy by means of coagulation analysis (activity of the blood coagulation factor IX in the patient's blood plasma).
In cases of prolonged bleeding prophylaxis in patients with severe hemophilia B, a dose of 10-25 IU / kg body weight should be used at intervals of 3-4 days.
Patients with antibodies to the coagulation factor IX (inhibitors) require special therapy. Immune tolerance can be achieved by treatment with a factor IX coagulation factor of the human.
The drug is recommended to be administered at a dose of not more than 100 ME / kg body weight / day. Dissolved drug is injected / in slowly.
Preparation of solution for intravenous administration
In the vial with lyophilizate, add the solvent through a double needle and rotate the vial until the lyophilizate is completely dissolved.
The lyophilizate can be dissolved more quickly by heating the solvent in a water bath (at a temperature of no higher than 37 В° C).
If the lyophilisate does not dissolve completely, filtration through the filter needle will be difficult.
The formation of foam can be avoided by slowly pouring the solvent onto the walls of the vial with the lyophilizate.
Once the solution is ready, you should dial it into the syringe, then replace the filter needle with the other and inject the solution iv slowly, using sterile injecting equipment from the kit.
The time of preparation of the solution should not exceed 3 minutes. After preparation, it must be used immediately. The contents of the vial should be used completely in one introduction. The solution remaining unused, is subject to destruction in the established order.
The prepared solution should be used immediately.
SIDE EFFECT
Rarely: allergic or anaphylactic reactions, an increase in body temperature, the appearance of antibodies to the coagulation factor IX human.
CONTRAINDICATIONS
- high risk of thrombosis, thromboembolism;
- a high risk of developing DIC syndrome;
- high risk of myocardial infarction;
- Hypersensitivity to the components of the drug.
PREGNANCY AND LACTATION
When using the coagulation factor concentrate IX in pregnant women during the clinical trials, complications are not established.
Experimental animal studies are not sufficient to assess the safety of the drug's effect on reproductive function, the development of an embryo or fetus, the course of pregnancy, and the peri- and postnatal development of a child.
Therefore, the concentrate (or preparations) of the blood coagulation factor IX can be used during pregnancy and during breastfeeding in cases of acute need, when the expected benefit exceeds the possible risk for a woman and a child.
SPECIAL INSTRUCTIONS
In cases of allergic or anaphylactic reactions, the drug should be stopped immediately and anti-shock therapy initiated if necessary.
Based on the experience of using preparations with a low purity of the blood clotting factor IX (concentrate of the prothrombin complex), there is a potential risk of thrombosis or disseminated intravascular coagulation when the drug is treated with the coagulation factor IX from human blood plasma. Because of the possible risk of thrombotic complications, precautions should be taken when using the IX coagulation factor drug in patients with cardiovascular disease, liver disease, post-operative patients, neonates, or patients at risk for thromboembolism or DIC. In all these situations, the potential advantage of treatment with the drug of coagulation factor IX of the human should be weighed taking into account the possible mentioned complications. After repeated use of the coagulation factor IX of the human, the level of the inhibitor in the plasma should be determined. The use of the blood coagulation factor IX in high doses can be associated with the risk of myocardial infarction, DIC syndrome, venous thrombosis and pulmonary embolism.
When medical products made from human blood or plasma are used, the incidence of infectious diseases as a result of the transmission of known and as yet unknown infectious agents can not be completely ruled out. In order to reduce the risk of transmission of infectious agents, careful selection of donors and harvested plasma is carried out by special testing for the absence of HIV type 1 and type 2, HBsAg, antibodies to HCV. In addition, each plasma pool is tested for polymerase chain reaction to detect the genome of viral hepatitis C.
In the process of production of the preparation Aimafiks, a double virusinactivation is carried out (solvent detergent method and heat treatment at 100 В° C for 30 min).
The drug can be used within the time limits indicated on the package. Usually the solution is transparent or slightly opalescent. Do not use a turbid solution, or if there is a flaky residue or other mechanical particles.
Impact on the ability to drive vehicles and manage mechanisms
It has not been established that the use of Amaxifix can adversely affect the ability to drive.
OVERDOSE
In case of an overdose, there is a threat of thromboembolic complications or DIC syndrome in patients.
DRUG INTERACTION
It is not known the interaction of the coagulation factor IX of the human with other drugs.
Do not mix the solution of Aimafiks with other medicines. To administer the drug, you can only use proven injectable kits from the enclosed kit.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored in a place protected from light and inaccessible to children at a temperature of 2 В° to 8 В° C. Shelf life - 2 years (provided the integrity of the package is preserved and the storage conditions are fully observed).
