Active substanceCoagulation factor VIIICoagulation factor VIII
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  • Dosage form: & nbspsolution for infusions [frozen]
    Composition:

    In 1 dose - not less than 100 units of coagulation factor VIII.

    Description:

    In the frozen state is a dense solidified mass of light yellow color.

    After thawing and complete dissolution (in a water bath at a temperature of 35 ° C to 37 ° C for no more than 7 minutes) - a clear, light yellow color, a flaked solution.

    Pharmacotherapeutic group:Hemostatic agent
    ATX: & nbsp

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

    Pharmacodynamics:

    Cryoprecipitate, frozen solution for infusion 100 ED - Protein preparation of human isogenic plasma, containing in one dose at least 100 units of factor of blood coagulation VIII. The composition of cryoprecipitate also includes fibrinogen and a small admixture of other proteins, including fibrin-stabilizing factor (factor XIII).

    Cryoprecipitate has a hemostatic effect with increased bleeding associated with a decrease in the activity of antihemophilic globulin (factor VIII),von Willebrand factor and fibrin-stabilizing factor.

    Indications:

    Treatment and prevention of bleeding in patients with hemophilia A and von Willebrand disease, as well as bleeding of another etiology, in which there is a sharp decrease in the content of factor VIII in plasma.

    Contraindications:

    Increased individual sensitivity.

    Pregnancy and lactation:

    Cryoprecipitate may be used during pregnancy and lactation, provided that the expected benefit to the mother exceeds the possible risk to the fetus and the baby.

    Dosing and Administration:

    The solution of cryoprecipitate is applied taking into account compatibility by blood groups of ABO. The container with the frozen cryoprecipitate is placed for thawing in a water bath at a temperature of 35-37 ° C. The drug dissolves completely at this temperature for 7 minutes. The resulting light yellow solution should not contain flakes and is used immediately after dissolution. The drug is administered intravenously, strontaneously, slowly using a syringe or a transfusion system with a disposable filter.

    The dose of cryoprecipitate depends on the initial content of coagulation factor VIII in the blood of a patient with hemophilia,character and localization of bleeding, the degree of risk of surgical intervention, the presence of a specific inhibitor in the patient's blood that can neutralize the activity of factor VIII. The dose of cryoprecipitate is expressed in units of factor VIII activity.

    To ensure effective hemostasis in the most frequent complications of hemophilia (hemarthrosis, renal, gingival and nasal bleeding), as well as when removing teeth, the content of factor VIII in plasma should not be less than 20% of activity; with intermuscular hematomas, gastrointestinal bleeding, fractures, trauma - not less than 40% of activity; at the majority of surgical interventions - not less than 70% of activity.

    The number of doses of cryoprecipitate necessary to increase the concentration of factor VIII in the blood to a predetermined level is calculated taking into account that the administration of the preparation in an amount of 1 unit per kg of body weight of the patient increases the content of factor VIII in the blood by an average of 1%

    X = Y x Z / 100, where

    X - dose of cryoprecipitate;

    U - body weight of the patient in kg;

    Z- the necessary content of factor VIII in the patient's blood;

    100 - the minimum content of factor VIII in units of activity in a single dose.

    After complete hemostasis administering the drug to patients with hemophilia is performed at intervals of 12-24 hours and at a dose providing an increase factor VIII content of not less than 20% activity. Such treatment is continued for several days - until complete relief of inflammatory changes or visible reduction in the size of the hematoma.

    In surgical interventions, the haemostatic dose of the drug is administered 30 minutes prior to surgery. With massive bleeding, the blood loss is compensated. The cryoprecipitate solution is reintroduced at the end of the operation at a dose equal to half the original dose. Within 3-5 days after the operation it is necessary to maintain the concentration of factor VIII in the patient's blood in the same range as during the operation. In the further postoperative period to maintain hemostasis, it is sufficient to increase the content of factor VIII to 20% of activity. The duration of the haemostatic therapy is, in most cases 7-14 days and depends on the nature of the surgery, bleeding localization features of reparative tissue.

    Side effects:

    During the introduction of the drug, paresthesia of the oral cavity can be noted, which passes immediately after the infusion (no treatment is required).

    In patients who have a history of reactions to transfusion of blood components, the introduction of cryoprecipitate may sometimes cause a slight chill and an increase in body temperature.

    Allergic reactions (urticaria, rashes, chest compressions, short-winded breathing, decreased blood pressure, anaphylaxis) are stopped by the administration of calcium preparations and antihistamines. Possible formation of antibodies to the coagulation factor VIII.

    Special instructions:

    Treatment of a patient with hemophilia with a solution of cryoprecipitate should be combined with the simultaneous administration of antifibrinolytic agents and glucocorticosteroid preparations in preventive and average therapeutic doses.

    Control of heart rate (HR) should be performed before and during therapy, with a significant increase in heart rate - slow down the rate or stop the drug.

    Cryoprecipitate is used taking into account compatibility by blood groups of ABO.

    When using cryoprecipitate there is a high risk of thrombosis, thromboembolism, myocardial infarction, and DIC syndrome.

    Repeated freezing of the drug is prohibited.

    Form release / dosage:Solution for infusions [frozen], 100 units.
    Packaging:

    For 100 units of factor VIII (15 ± 5 ml), in polymer containers with a capacity of 300 ml. Polymeric containers are placed in thermal containers together with instructions for use.

    Storage conditions:At a temperature of no higher than minus 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    6 months.

    Do not use after the expiration date.

    Terms of leave from pharmacies:On prescription
    Registration number:LSR-005898/08
    Date of registration:23.07.2008
    Expiration Date:Unlimited
    The owner of the registration certificate:REPUBLICAN STATION OF BLOOD TRANSFUSION (UFA), GOOSE REPUBLICAN STATION OF BLOOD TRANSFUSION (UFA), GOOSE Russia
    Manufacturer: & nbsp
    Information update date: & nbsp23.01.2018
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