Active substanceCoagulation factor VIIICoagulation factor VIII
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  • Dosage form: & nbspsolution for intravenous administration [frozen]
    Composition:In 1 dose - 15 ± 5 ml, not less than 100 units of factor VIII.
    Description:

    In the frozen state - dense solidified mass of yellowish color.

    After thawing - a clear solution of a yellowish color, without flakes.

    Pharmacotherapeutic group:Hemostatic agent
    ATX: & nbsp

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

    Pharmacodynamics:

    Cryoprecipitate has antihemorrhagic effect with increased bleeding, associated with a decrease in the activity of the anti-hemophilic factor (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 the blood plasma.

    Contraindications:

    Increased individual sensitivity.

    Contraindications to the use of cryoprecipitate solution in patients with hemophilia have not been established.

    Carefully:

    Pregnancy, lactation.

    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 with a syringe or 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 activity VIII.

    To ensure effective hemostasis in the most frequent complications of hemophilia (hemarthrosis, kidney,gingival and nasal bleeding), as well as when removing teeth, the content of factor VIII in the plasma should be not less than 20%, with intermuscular hematomas, gastrointestinal bleeding, fractures, trauma - no less than 40%, with most surgical interventions not less than 70% .

    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 drug is administered in the amount of 1 unit per kg of body weight, the patient increases the factor VIII content in the blood by an average of 1%, according to the formula:

    X = Y x Z / 100, where

    X - 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 stopping of bleeding, the administration of the drug to patients with hemophilia is carried out at intervals 12-24 hour and in a dose providing an increase in the content of factor VIII by at least 20%. 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 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 subsequent postoperative period, to maintain hemostasis, it is sufficient to increase the content of factor VIII to 20%.

    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 introduction of the drug in some patients there is paresthesia of the oral mucosa, which passes 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 a solution 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).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 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 intravenous administration [frozen], 100 units.
    Packaging:

    In plastic bags of domestic or imported production with a capacity of 300 ml in a volume of 15 ml (1 dose). A plastic bag with the drug is put in a transparent polyethylene bag together with instructions for use.

    Storage conditions:

    At a temperature not higher than -25 ° ะก.

    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-000474/09
    Date of registration:27.01.2009
    Expiration Date:Unlimited
    The owner of the registration certificate:SAMARA REGION OF TRANSFUSION OF BLOOD SAMARA REGION OF TRANSFUSION OF BLOOD Russia
    Manufacturer: & nbsp
    Information update date: & nbsp23.01.2018
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