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

    In 1 dose - 15 ± 5 ml, not less than 100 units of factor VIII.

    Description:

    In the frozen state, the solid solidified mass is yellowish in color.

    After thawing and complete dissolution (in a water bath at a temperature of + 35-37 ° C for no more than 7 minutes) a transparent yellowish color, a flaked solution, is formed.

    Pharmacotherapeutic group:Hemostatic agent
    ATX: & nbsp

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

    Pharmacodynamics:

    Cryoprecipitate is a protein preparation of human isogenous plasma, containing in one dose not less than 100 U / 15 ml of the coagulation factor 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 used taking into account the compatibility of ABO blood groups. A bag of frozen cryoprecipitate solution for thawing is placed in a water bath at a temperature of 35-37 ° C. The drug dissolves completely at this temperature for 7 minutes. The resulting yellowish solution should not contain flakes and should be used immediately after dissolution. The drug is injected intravenously slowly using a transfusion system with a disposable filter.

    The dose of cryoprecipitate depends on the initial content of factor VIII in the patient's blood, the nature 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 be not less than 20% of activity, with intermuscular hematomas, gastrointestinal bleeding, fractures, trauma - not less than 40% of activity, with most 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 when the preparation is administered in the amount of 1 unit per 1 kg of the body weight of the patient, the content of the factor VIII in the blood on average by 1%, according to the formula:

    X = Y x Z / 100, where

    X is the dose of cryoprecipitate, Y - body weight of the patient in kg, Z - the necessary content of factor VIII in the blood of the patient, 100 - the minimum content of factor VIII in units of activity in a single dose.

    After complete stoppage of bleeding, the administration of the drug to patients with hemophilia is carried out at intervals of 12-24 hours and in a dose providing an increase in the content of factor VIII by not less than 20% of activity.Such treatment is continued for several days until the complete relief of inflammatory changes or a visible decrease in the size of the hematoma.

    In surgical interventions, the haemostatic dose of the drug is administered 30 minutes before the operation. 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 the activity of the factor VIII.

    The duration of hemostatic therapy is in most cases 7-14 days and depends on the nature of the surgical intervention, the localization of bleeding, and reparative tissue features.

    Side effects:

    During the administration of the drug in some patients, paresthesia of the oral mucosa is noted, passing immediately after the end of the transfusion (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.The reaction is stopped by the administration of calcium preparations and antihistamines.

    Allergic reactions (urticaria, rash, a feeling of compression in the chest, stridoroznoe breath, lowering blood pressure, anaphylaxis).

    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 done before and during therapy, with a significant increase in heart rate - slow the rate of infusion or stop the drug.

    Cryoprecipitate is used taking into account group compatibility according to the ABO system.

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

    Form release / dosage:

    Solution for infusions [frozen], 100 units.

    Packaging:

    For 100 units / 15 ± 5 ml of the preparation in plastic bags from containers for collection of donor blood (composters) of domestic production with a capacity of 300 ml.

    Storage conditions:

    At a temperature not higher than -25 ° C in a place inaccessible to children.

    Shelf life:

    6 months.

    Do not use after the expiration date.

    Terms of leave from pharmacies:For hospitals
    Registration number:LSR-000867/10
    Date of registration:10.02.2010
    Expiration Date:Unlimited
    The owner of the registration certificate:Voronezh Regional Blood Transfusion Station Voronezh Regional Blood Transfusion Station Russia
    Manufacturer: & nbsp
    Information update date: & nbsp22.01.2018
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