Description of the dosage form
Lyophilizate for the preparation of a solution for intravenous administration; in the form of a powder or loose solid mass of white or white with a yellowish tint, without foreign inclusions.
Pharmacotherapeutic group
hemostatic drug.
Coagulation factors II, VII, IX and X together form the prothrombin complex. The synthesis of these factors depends on vitamin K and is carried out in the liver.
Factor VII is the zymogen of the active serine-protease factor VIIa, through which the endogenous pathway of blood coagulation is initiated. The complex tissue factor – factor VIIa activates coagulation factors X and IX, as a result of which factors Xa and IXa are formed. With further activation of the coagulation cascade, prothrombin (factor II) is activated and converted to thrombin. Under the action of thrombin, fibrinogen is converted to fibrin, which leads to the formation of a clot. Normal thrombin synthesis is also a necessary condition for the participation of platelets in primary hemostasis.
Deficiency of these blood coagulation factors is manifested by increased bleeding, hemorrhages, and in severe cases – bleeding of various localization, incl. retroperitoneal, cerebral, gastrointestinal. Acquired deficiency of coagulation factors is a consequence of vitamin K deficiency, which, in turn, can develop as a result of violations of its synthesis or absorption. In this case, there is a deficiency of all four clotting factors, as well as the natural anticoagulant protein C.
Congenital deficiency is hereditary in nature and usually has an isolated character, i.e. manifested by a deficiency of any one coagulation factor. Congenital isolated deficiency of factor IX is one of the classic types of hemophilia (hemophilia B). Isolated deficiency of factor VII leads to a decrease in thrombin formation and causes increased bleeding due to a decrease in fibrin formation and impaired primary hemostasis. Isolated deficiency of factor II or factor X is very rare; in severe forms, it is accompanied by increased bleeding, as in cases of classical hemophilia.
The use of the human prothrombin complex preparation provides an increase in the levels of vitamin K-dependent coagulation factors in plasma and temporarily eliminates coagulation disorders in patients with acquired or congenital deficiency of all or one blood coagulation factor.
Pharmacokinetics
With the on / in the introduction of the drug, an increase in plasma concentration of all four coagulation factors occurs, depending on the size of the administered dose. During subsequent consumption, plasma concentrations of factors gradually decrease.
The shortest T1 / 2; has factor II – 40-60 hours, T1 / 2; factor VII – 3-5 hours, factor IX – 16-30 hours, factor X – 30-60 hours.
Clinical pharmacology
Preparation of plasma factors (II, VII, IX, X) of blood coagulation.
Indications for use
Treatment and prevention of bleeding during surgery in patients with acquired deficiency of prothrombin complex factors, for example, in deficiency caused by treatment with vitamin K antagonists or an overdose of vitamin K antagonists, in cases where rapid correction of the deficiency is required; treatment and prevention of bleeding during surgical interventions in patients with congenital deficiency of one of the vitamin K-dependent coagulation factors, in cases where a monocomponent preparation of a deficient coagulation factor is not available.
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