Cryoprecipitate - instructions for use, dose, side effects, contraindications

After dissolution in water for injection in an amount of 50 ml at a temperature of 36 ± 1 ° C - a transparent opalescent liquid of light yellow color.

Pharmacotherapeutic group:Hemostatic agent

ATX: & nbsp

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

Pharmacodynamics:

Cryoprecipitate is a protein preparation of human isogenic plasma, which contains mainly coagulation factor VIII. The composition of cryoprecipitate also includes fibrinogen and a small admixture of other proteins, including fibrin-stabilizing factor.

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:

Prevention and treatment of bleeding in patients with hemophilia A, von Willebrand disease, also with bleeding of another etiology, in which there is a sharp decrease in the concentration of factor VIII in plasma.

Contraindications:

Increased individual intolerance.

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:

When introducing cryoprecipitate, compatibility with ABO blood groups should be considered. Preparation before use dissolve in 50 ml of water for injection, at a temperature of 35-37 ° C. The drug dissolves completely within 7 minutes. The obtained solution of light yellow color should not contain flakes and is applied immediately after dissolution.

Intravenously injected, slowly using 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,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 be not less than 20% of activity, with intermuscular hematomas, gastrointestinal bleeding, fractures, injury is not less than 40% of the activity, with most surgical interventions not less than 70% of the 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 kg of body weight of the patient, the blood factor VIII is increased by an average of 1% according to the formula:

X = YxZ / 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 patient's blood, 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 of 12-24 hours 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 produce replenishment of blood loss. 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 blood of the patient within the limits 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 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 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, chest compressions, AD, anaphylaxis), the formation of antibodies to the coagulation factor VIII.

Special instructions:

This drug is made from human plasma, which can be a source of hepatitis and other viral diseases. All the diseases detected by the doctor and, possibly, caused by this drug must be reported to the manufacturer of the drug.

The heart rate (heart rate) should be determined before and after the administration of the drug. With a significant increase in heart rate, it is necessary to reduce the rate of administration or to suspend the administration of the drug, which usually allows you to quickly eliminate these symptoms.

During the treatment period it is recommended to conduct appropriate laboratory studies of the patient's plasma (at convenient intervals for him) to control the achievement and maintenance of an adequate level of anti-hemophilic factor (AGF).If the concentration of AGP in the plasma of the patient does not reach the desired level or the bleeding can not be controlled against the background of an adequate dose, consideration should be given to the presence of inhibitors that are quantitatively determined in neutralized antihemophilic units in 1 ml of plasma or in the total volume of plasma. If the concentration of the inhibitor does not exceed 10 U / ml, then after the administration of a sufficient amount of AGP, an additional amount of AGP may be added to neutralize the inhibitor.

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

Form release / dosage:

Lyophilizate for solution for infusion, 200 units.

Packaging:

By 200 units of factor VIII in bottles of glass for blood, transfusion and infusion preparations with a capacity of 250 ml hermetically sealed with stoppers made of rubber, rolled with aluminum caps and filled with Unna paste. Labels are put on bottles.

Each bottle is placed in a pack of cardboard, put the instruction or put in a box of cardboard with gaskets and grills of 28 bottles with a capacity of 250 ml, without bundles with 10 instructions for use

Storage conditions:

At a temperature of 5 to 20 ° C in a dry, protected from light and out of reach of children.

Shelf life:

1 year.

Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:LSR-009032/10

Date of registration:31.08.2010

Expiration Date:Unlimited

The owner of the registration certificate:STATION TRANSFUSION OF BLOOD DZ KRASNODAR TERRITORY, GOOSE STATION TRANSFUSION OF BLOOD DZ KRASNODAR TERRITORY, GOOSE Russia

Manufacturer: & nbsp

STATION OF BLOOD TRANSFUSION OF GUS DZ OF KRASNODAR TERRITORY Russia

Information update date: & nbsp22.01.2018

Illustrated instructions

Instructions

Cryoprecipitate (Cryoprecipitate)