Clinical and pharmacological group: & nbsp

Coagulants (including clotting factors), hemostatics

Included in the formulation
  • Hemate® P
    lyophilizate in / in 
    CESEL Behring GmbH     Germany
  • 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.06   Factors of blood coagulation von Willebrand and VIII in combination

    Pharmacodynamics:

    Activates the clotting factor X, which leads to an acceleration of the prothrombin transition in thrombin, as a result of which a thrombus is formed (due to the transition of fibrinogen to fibrin). At the site of damage, the vessel is attached to the vascular subendothelium and to the platelet membrane, providing primary hemostasis. As a result, coagulation time decreases in patients with Willebrand disease. Promotes the adhesion of platelets in the area of ​​vascular damage and activates platelet aggregation. Reduces the risk of bleeding due to correction of the deficiency of clotting factors.

    Pharmacokinetics:

    In patients with hemophilia A, the elimination half-life is 12 hours.

    The coagulation factor VIII activity is reduced by 15% within 12 hours.

    With increasing temperature, the half-life of coagulation factor VIII may decrease.

    Indications:

    It is used to treat and prevent bleeding in patients with Willebrand's disease, congenital hemophilia A, or acquired bleeding factor deficiency VIII.

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

    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:

    Intravenously, the initial dose is 20-50 IU / kg body weight. In von Willebrand disease, the dose depends on the severity of the condition, the type of bleeding, the level of the clotting factor VIII.

    For bleeding dangerous to life: 60-100 IU / kg every 8-12 hours.

    With moderate bleeding: 20-40 IU / kg every 12-24 hours.

    In order to prevent bleeding:

    - with small surgical interventions: 30-60 IU / kg 30 minutes prior to surgery and within 12-24 hours after surgical treatment (including tooth extraction);

    - for large surgical interventions: 80-100 IU / kg 30 minutes prior to surgery and within 12-24 hours after surgical treatment.

    The highest daily dose: 200 IU / kg.

    The highest single dose: 100 IU / kg.

    Side effects:

    Central and peripheral nervous system: 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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