Active substanceCoagulation factor IXCoagulation factor IX
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  • Dosage form: & nbsplyophilizate for solution for infusion
    Composition:

    One bottle contains:

    factor IX - 250 ME;

    Excipients: sodium chloride - 100 mmol / l; sodium citrate - 60 mmol / l; glycine - 80 mmol / l.

    Description:Amorphous powder of white color. After dissolution, a clear or slightly opalescent liquid, colorless or slightly yellowish in color.
    Pharmacotherapeutic group:Hemostatic agent
    ATX: & nbsp

    B.02.B.D.04   Coagulation factor IX

    Pharmacodynamics:

    Aghemfil B contains the purified concentrate of the factor EX of blood coagulation, which is obtained from the pool of freshly frozen blood plasma of donors. Control for the absence of a surface antigen of the hepatitis B virus (HBsAg), antibodies to the hepatitis C virus (anti-HCV) and to the human immunodeficiency virus HIV-1 / HIV-2 is carried out by means of an enzyme immunoassay. Coagulation factor IX in plasma restores hemostasis in patients with deficiency. Active form factor IX - factor IXa - in combination with factor VIII activates factor X, which promotes the transition of prothrombin into thrombin and the formation of a fibrin clot. Increases plasma levels of vitamin K-dependent coagulation factors (II, VII, IX, and X). With a decrease in the plasma level of factor IX below 5% of the norm, the risk of spontaneous hemorrhages increases sharply, and a content above 20% of the norm ensures satisfactory hemostasis.

    Pharmacokinetics:About 40% of factor IX is detected in the blood immediately after intravenous infusion; then the haemostatic activity gradually decreases. T1/2 - 20 hours.
    Indications:

    Treatment and prevention of bleeding in patients with hemophilia B, including during an emergency or planned surgical intervention.

    Contraindications:

    Individual hypersensitivity to the drug, DIC-syndrome, acute thrombosis, acute myocardial infarction, deficiency of factor VII, acute hepatic insufficiency.

    Pregnancy and lactation:

    Studies of the influence of Agemphil B on the reproductive capacity of animals have not been conducted. It is not known whether Aghemfil B can cause fetal damage or affect reproductive capacity when administered to a pregnant woman.Aghemfil B should be given to women only if the expected benefit exceeds the possible risk for both the woman and the fetus / child.

    Dosing and Administration:

    The drug is used only intravenously aftere complete dissolution in 20 ml of water for injection.

    The recommended rate of administration is -100 IU / min.

    Preparation of the solution: Aghemil B must be diluted only in sterile water for injection. Before breeding vial with drug and sterile water for injections should be brought to a temperature of 20-30 ° C. Sterile disposable needle and syringe to collect the required volume of sterile water for injection (20 ml) and insert it into the vial with the drug. For complete dissolution, gently shake the bottle, not shaking. After 3-5 minutes, a clear or slightly opalescent solution should be obtained. Dilute the drug for 1 hour after preparation. In education gel or clot in a vial the resulting solution can not be used.

    The dose of Agamphil B to restore hemostasis is selected individually, depending on the degree of bleeding and the required level of factor IX in blood plasma.The following formula can be recommended for dose calculation:

    Required dose = necessary increase in activity. IX (%) × body weight (kg) / 1 (% / IU / kg)

    To achieve a satisfactory clinical result, it is necessary to correlate the therapeutic effect with the data of measurements of the level of factor IX in the patient's blood plasma. The required dose of the drug for a single administration and the duration of treatment depends on the severity of factor IX deficiency, as well as the location and volume of bleeding and the clinical condition of the patient.

    Light bleeding. For treatment of superficial or beginning bleeding within 2-3 days, a dose of Aghemfil B is introduced, which allows maintaining the concentration of factor IX in blood plasma at 30%.

    Moderate bleeding. For the treatment of moderate bleeding, the level of factor IX should be raised to 30-50% by administration of Aghemil B within 3-4 days at intervals of 12-14 hours.

    Severe haemorrhage. In patients with life-threatening bleeding or bleeding to vital organs (central nervous system, zygopharyngeal or retroperitoneal space, ilio-lumbar muscle), the level of factor IX in blood plasma should be increased to 80-100% by administration of Aghemil B within 10-14 days with intervals of 12-14 hours.

    Surgery. The intensity of the replacement therapy with Agymphil B depends on the type of surgical operation and the subsequent postoperative regimen. With extensive surgical interventions, the level of factor IX should be maintained at a level of at least 50%. For this purpose, transfusions of Agymphil B can be repeated every 6-12 hours for 10-14 days.

    Prevention. The scheme preventive treatment should be adjusted in accordance with the individual needs of the patient. Usually, for maintenance therapy in patients with severe hemophilia is a dose of 20-30 IU / kg of Agymphil B, administered 3 times a week in order to maintain 3-5% of the level of factor IX in blood plasma.

    Side effects:

    Too fast administration of the drug can sometimes cause a brief increase in body temperature, chills, headache. In some cases, nausea, tachycardia, tingling sensations in the body, back pain, postoperative thrombosis, allergic reactions (urticaria, anaphylactic reaction), a decrease in resistance to infectious diseases can occur.

    Overdose:Symptoms of an overdose of Agymphyl B are unknown.
    Interaction:

    Unknown.

    Agyfil B should not be injected into any syringe with any other medications.

    Effect on the ability to drive transp. cf. and fur:

    Indications that Agamphil B can reduce the ability to drive a car or work with machines, no.

    Form release / dosage:

    Lyophilizate for solution for infusion, 250 ME.

    Packaging:

    By 250 ME factor IX in glass bottles with a capacity of 30 ml.

    Storage conditions:

    Store at a temperature of 2 to +8 ° C.

    Keep out of the reach of children.

    Shelf life:

    2 years.

    Do not use the product after the expiration date printed on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:P N002032 / 01
    Date of registration:14.04.2009/14.05.2014
    Expiration Date:Unlimited
    The owner of the registration certificate:Hematology Research Center, FGBU of the Ministry of Health of the Russian FederationHematology Research Center, FGBU of the Ministry of Health of the Russian Federation Russia
    Manufacturer: & nbsp
    Information update date: & nbsp21.01.2017
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