Clinical and pharmacological group: & nbsp

Coagulants (including clotting factors), hemostatics

Included in the formulation
  • Agemphil A
    lyophilizate d / infusion 
  • Beriaute®
    lyophilizate in / in 
    CESEL Behring GmbH     Germany
  • Hemoctin
    lyophilizate in / in 
    Biotest Pharma GmbH     Germany
  • Hemofil M
    lyophilizate in / in 
    Baxter Khelskea SA     Ireland
  • Immunate
    lyophilizate in / in 
    Baxter AG     Austria
  • Coate-DWI
    lyophilizate in / in 
  • Cryoprecipitate
    lyophilizate d / infusion 
  • Cryoprecipitate
    solution d / infusion 
  • Cryoprecipitate
    solution d / infusion 
  • Cryoprecipitate
    solution in / in 
  • Cryoprecipitate
    solution in / in 
  • Cryoprecipitate
    solution d / infusion 
  • Cryoprecipitate
    solution d / infusion 
  • Cryoprecipitate
    solution d / infusion 
  • LongAyt
    lyophilizate in / in 
    Recoli N.V.     Netherlands
  • Nuwick
    lyophilizate in / in 
    Octapharma AB     Sweden
  • Octanate
    lyophilizate in / in 
  • Fundy®
    lyophilizate d / infusion 
  • Emoklot D.I.
    lyophilizate d / infusion 
    Kedrion SpA     Italy
  • Included in the list (Order of the Government of the Russian Federation No. 2782-r of 30.12.2014):

    VED

    7 nosologies

    АТХ:

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

    Pharmacodynamics:Compensates the defect of blood coagulation in patients with hemophilia A. It is combined with the protein C factor VIII and von Willebrand factor. Strengthens the process of blood clotting, promoting the transition of prothrombin in thrombin, and also accelerates the formation time of the fibrin clot.

    Pharmacokinetics:After intravenous administration, the maximum concentration in the blood plasma is reached after 10-120 minutes.

    The half-life period is 8-19 hours, it is shortened by hyperthermia.

    Indications:It is used to treat and prevent bleeding in patients with Willebrand's disease, congenital hemophilia A, or acquired bleeding factor deficiency VIII. Used to prevent and treat acute bleeding in patients with vitamin K deficiency and liver failure.

    III.D65-D69.D67   Hereditary deficiency of factor IX

    III.D65-D69.D66   Hereditary deficiency of factor VIII

    XVIII.R50-R69.R58   Bleeding, not elsewhere classified

    III.D65-D69.D68.4   Acquired Coagulation Factor Deficiency

    Contraindications:Syndrome of disseminated intravascular coagulation, hyperfibrinolysis, heparin-induced thrombocytopenia in history, children under 6 years of age, individual intolerance.

    Carefully:Ischemic heart disease, pregnancy and lactation, hypersensitivity.

    Pregnancy and lactation:

    Recommendations for FDA - Category C. It is used with caution during pregnancy and lactation in cases where the intended benefit exceeds the risk to the fetus and newborn.

    Dosing and Administration:

    Intravenous, with mild bleeding: 10 IU / kg body weight.

    For bleeding dangerous to life: 40-50 IU / kg followed by a maintenance dose of 20-25 IU / kg every 8-12 hours.

    With moderate bleeding: 15-25 IU / kg, then 10-15 IU / kg every 12-24 hours.

    In order to prevent bleeding:

    - at small surgical interventions: 30-60 IU / kg 30 minutes prior to surgery followed by a maintenance dose of 20-25 IU / kg every 8-12 hours in 12-24 hours after surgery (including tooth extraction) ;

    - for large surgical interventions: 40-50 IU / kg 1 hour before the operation and 20-25 IU / kg 1 hour after the first administration and every 8-24 hours.

    For prolonged prevention of bleeding in severe haemophilia A - 12-25 IU / kg every 2-3 days.

    The highest daily dose: 200 IU / kg.

    The highest single dose: 100 IU / kg.

    Side effects:General reactions: hyperthermia, anxiety, headache, apathy, drowsiness.

    Respiratory system: shortness of breath.

    The cardiovascular system: arterial hypotension, feeling of compression in the chest.

    Digestive system: transient paresthesia of the oral mucosa, nausea, vomiting.

    Local Reactions: burning sensation at the injection site.

    Allergic reactions.

    Overdose:Cases of overdose are not described.

    Treatment is symptomatic.

    Interaction:It is forbidden to mix the drug with other medicines in the same syringe, infusion solution.

    Danazol increases the activity of coagulation factor VIII.

    Special instructions:

    Control of coagulation factor VIII concentration in order to avoid thrombosis during long-term treatment.

    In the treatment it is not recommended to drive vehicles and work with moving mechanisms.

    Instructions
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