Clinical and pharmacological group: & nbsp

Coagulants (including clotting factors), hemostatics

Included in the formulation
  • Coaplex
    lyophilizate in / in 
    CESEL Behring GmbH     Germany
  • OCTAPLEX®
    lyophilizate in / in 
  • Prothromplex 600
    lyophilizate in / in 
    Baxter AG     Austria
  • Included in the list (Order of the Government of the Russian Federation No. 2782-r of 30.12.2014):

    VED

    АТХ:

    B.02.B.D.01   Factors of blood coagulation IX, II, VII and X in combination

    B.02.B.D   Coagulation factors

    Pharmacodynamics:In the human body is converted into activated factor IX and in combination with factor VIII promotes platelet adhesion. In the zone of vascular damage, platelet aggregation activates, which causes the prothrombin to pass into thrombin and promotes the formation of a fibrin clot. Increases in blood plasma levels of vitamin K-dependent factors of blood coagulation (II, VII, IX, X). By replenishing the deficiency of clotting factors reduces the risk of bleeding.

    Pharmacokinetics:After intravenous administration of the drug in the blood serum, about 30-40% of the coagulation factors are determined, then the haemostatic activity gradually decreases.

    Half-life for factors II, VII, IX, X is 40-60 minutes, 3-5 hours, 16-30 hours, 30-60 hours respectively.

    Indications:It is used for the treatment and prevention of bleeding with congenital deficiency of one or several factors: factor II, factor IX, factor X. It is used to treat and prevent bleeding in patients with vitamin K deficiency and liver diseases. Used to treat bleeding when syndrome of disseminated intravascular coagulation, as well as hemophilia A and B.

    III.D65-D69.D65   Disseminated intravascular coagulation [defibrillation syndrome]

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

    III.D65-D69   Blood clotting disorders, purpura and other hemorrhagic conditions

    III.D65-D69.D68   Other coagulation disorders

    IV.E50-E64.E56.1   Insufficiency of vitamin K

    III.D65-D69.D69.9   Hemorrhagic condition, unspecified

    III.D65-D69.D69.8   Other specified hemorrhagic conditions

    XXI.Z100.Z100 *   CLASS XXII Surgical Practice

    Contraindications:High risk of thrombosis, individual intolerance.

    Carefully:Pregnancy and lactation, the period of newborns, the postoperative period, ischemic heart disease, myocardial infarction in the anamnesis, 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, for the purpose of replacement therapy, depending on the severity of the clinical picture, the laboratory parameters of blood, volume and localization of bleeding.

    For patients taking oral anticoagulants - for 35-50 IU / kg.

    When syndrome of disseminated intravascular coagulation and liver diseases, the initial dose is 50 IU / kg, if necessary, repeated administration after 6-12 hours.

    With inhibitory forms of hemophilia A and B, 75 IU / kg every 8-12 hours.

    Side effects:Local Reactions: burning sensation at the injection site.

    General reactions: hyperthermia.

    Allergic reactions.

    Overdose:

    Myocardial infarction, vein thrombosis, pulmonary embolism.

    Treatment is symptomatic.

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

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

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