Active substanceCoagulation factor VIIICoagulation factor VIII
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  • Dosage form: & nbsplyophilizate for solution for infusion
    Composition:

    One bottle contains 250 ME factor VIII.

    Excipients: sodium chloride, sodium citrate, glycine, lysine, calcium chloride, human albumin.

    Description:

    Lyophilizate white color.

    Dissolved drug: clear or slightly opalescent liquid, colorless or slightly yellowish-colored.

    Pharmacotherapeutic group:Hemostatic agent
    ATX: & nbsp

    B.02.B.D.02   Coagulation factor VIII

    Pharmacodynamics:

    Agamphil A contains purified concentrate of the VIII coagulation factor, which is obtained from a pool of freshly frozen blood plasma from 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.

    Introduction Agamphil A provides an increase in the content of a specific plasma protein - factor VIII of blood clotting and temporarily eliminates the hemocoagulation defect in patients with hemophilia A (hereditary bleeding due to a reduced or absent VIII factor in the blood plasma).

    Indications:

    Treatment and prevention of bleeding, in patients with classical hemophilia (hemophilia A), including during emergency or planned surgical intervention.

    Agamphil A has not been studied in terms of the effectiveness of treatment for Willebrand-Jurgens disease and, therefore, can not be recommended for the treatment of this disease.

    Contraindications:

    There are no known contraindications, except for the rarely encountered individual intolerance of the drug.

    Pregnancy and lactation:

    Studies of the influence of Agemphil A on the reproductive capacity of animals have not been conducted. It is not known whether Agamphil A can cause fetal damage or affect reproductive capacity when administered to a pregnant woman. Agamphil A should be given to pregnant women only on absolute indications.

    Dosing and Administration:

    The drug is used only for intravenous administration after complete dissolution in 20 ml of water for injections. The recommended rate of administration is 100 units of activity per minute.

    Preparation of the solution

    Agamphil A should be diluted only in sterile water for injection. Prior to dilution, the vial with the preparation and sterile water for injection 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 Agymphil A. For complete dissolution, gently shake the bottle, not shaking. Across 10-15 minutes should be a clear or slightly opalescent solution. The diluted drug should be used no later than 1 hour after preparation.

    In education gel or clot of the bottle can not be used.

    The dose of Agymphil A to restore hemostasis is selected individually, depending on the degree of bleeding, the presence of inhibitors and the required level of factor VIII.

    The introduction of one unit (ME) of factor VIII per kg of body weight increases the level of factor VIII in blood plasma by an average of 1% and the following formula can be recommended for calculating the dose:

    Required dose = required increase in factor VIII activity (%) x 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 VIII in the patient's blood plasma.

    If the bleeding can not be controlled with the calculated dose and the expected concentration of factor VIII in the blood plasma is reached, the patient should be suspected of the presence of a circulating inhibitor to factor VIII. Its presence and quantity (titer) should be confirmed by appropriate laboratory tests. Some patients with a low inhibitor titer (10 Bethesda units) can be successfully treated with Agymphil A. Patients with higher inhibitor titers may require the use of such drugs as: concentrate of Factor IX Complex, Antigemophilic Factor (Porcine) or Anti-Inhibitor Coagulation Complex .

    The necessary number of units of Aghemfil A activity for a single administration and the duration of treatment depends on the severity of Factor VIII 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, enter such therapeuticallythe necessary dose of Aghemfil A, which allows you to maintain the concentration of Factor VIII in the blood plasma at 30%.

    Moderate bleeding: For the treatment of moderate bleeding (eg, single hemarthrosis, limited trauma), Factor VIII level should be raised to 30-50% by administration of Agemphil A for 3-4 days at intervals of 12-14 hours.

    Severe bleeding: In patients with life-threatening bleeding or bleeding to vital organs (central nervous system, zagochoroteca or retroperitoneal space, iliac-lumbar muscle), the level of Factor VIII in the blood plasma should be increased to 80-100% by administration of Agymphil A within 10-14 days from intervals of 12-14 hours.

    Surgery: The intensity of the replacement therapy with Agymphil A depends on the type of surgery and the subsequent postoperative regimen. In large surgical interventions, the level of Factor VIII should be maintained at values ​​not less than 50%. For this purpose, transfusions of Agymphil A can be repeated every 6-12 hours for 10-14 days.

    Prevention: The scheme of preventive treatment should be adjusted in accordance with the individual needs of the patient.Typically, for maintenance therapy in patients with severe hemophilia, the dose of 20-30 IU / kg of Agymphil A administered 3 times a week is effective to maintain a 3-5% level of Factor VIII 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 Agymphil A are unknown.

    Interaction:

    Unknown. Agamphil A should not be administered in the same syringe with any other medications.

    Special instructions:

    Agamphil A has not been studied in terms of the effectiveness of treatment for Willebrand-Jurgens disease and, therefore, can not be recommended for the treatment of this disease.

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

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

    Form release / dosage:

    Lyophilizate for solution for infusion, 250 IU.

    Packaging:

    250 each ME factor VIII in glass bottles with a capacity of 30 ml. The vial is placed in a cardboard box together with instructions for use.

    Packing for hospitals: 40 vials with instructions for use in a cardboard box.

    Storage conditions:At a temperature of 2-6 ° C.

    In a place inaccessible to 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:LS-001796
    Date of registration:18.05.2012/29.05.2014
    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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