Cryoprecipitate

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Cryoprecipitate: instructions for use and reviews

1. Release form and composition
2. Pharmacological properties
3. Indications for use
4. Contraindications
5. Method of application and dosage
6. Side effects
7. Overdose
8. Special instructions
9. Application during pregnancy and lactation
10. Drug interactions
11. Analogs
12. Terms and conditions of storage
13. Terms of dispensing from pharmacies
14. Reviews
15. Price in pharmacies

Latin name: Cryoprecipitate

ATX code: B02BD02

Active ingredient: blood coagulation factor VIII (Coagulation Factor VIII)

Manufacturer: Astrakhan Regional Blood Transfusion Station (Russia); Blood transfusion station GUZ DZ Krasnodar Territory (Russia); Voronezh regional blood transfusion station GUZ (Russia); Belgorod Regional Blood Transfusion Station (Russia); Mordovian Republican Blood Transfusion Station GUZ (Russia)

Description and photo update: 2019-01-07

Lyophilisate for preparation of solution for infusion Cryoprecipitate

Cryoprecipitate is a hemostatic agent.

Release form and composition

lyophilisate for preparation of solution for infusion: porous dry mass from pale yellow to white, odorless; after dilution of the drug in water for injection in an amount of 50 ml at a temperature of 36 ± 1 ° C, an opalescent transparent liquid of pale yellow color is formed [200 units of action (U) of factor VIII in a glass bottle for blood, infusion and transfusion preparations with a volume of 250 ml, a hermetically sealed rubber stopper, sealed with an aluminum cap and filled with Unna paste; in a cardboard box 1 bottle or in a cardboard box with gaskets and grids 28 bottles];
solution for infusion (frozen): in frozen state - hardened dense mass of pale yellow or yellow color; after thawing and complete dissolution (at a temperature of 35–37 ° C for no more than 7 minutes in a water bath) - a transparent or slightly opalescent (depending on the manufacturer) solution of a pale yellow color, free of flakes [1 dose (100 U / 15 ± 5 ml) in a plastic bag from a container for collecting donor blood (compoplast) of domestic production with a volume of 300 ml or in a polymer container with a volume of 300 ml. There is 1 container in a thermocontainer or 10 containers in a box].

The preparation is accompanied by instructions for the use of Cryoprecipitate.

1 bottle with a lyophilisate for the preparation of a solution for infusion contains at least 200 IU of coagulation factor VIII with the addition of a glucose stabilizer.

1 plastic bag or polymeric container with solution for infusion (frozen) contains at least 100 units of coagulation factor VIII (15 ± 5 ml - 1 dose).

Pharmacological properties

Pharmacodynamics

Cryoprecipitate is a protein preparation of isogenic human blood plasma, which mainly includes blood coagulation factor VIII. The preparation also contains fibrinogen and a minor admixture of other proteins, including fibrin-stabilizing factor (factor XIII).

The drug demonstrates a hemostatic effect against the background of increased bleeding caused by a weakening of the activity of fibrin-stabilizing factor, von Willebrand factor and antihemophilic globulin (factor VIII).

Indications for use

The indication for Cryoprecipitate is the therapy and prevention of bleeding in patients with von Willebrand disease and hemophilia A. Also, the drug is used against the background of bleeding of a different etiology, which is characterized by a sharp decrease in the concentration of factor VIII in plasma.

Contraindications

The use of Cryoprecipitate is contraindicated in the presence of increased individual sensitivity to this drug.

Cryoprecipitate, instructions for use: method and dosage

The infusion solution of Cryoprecipitate is carried out taking into account the compatibility of the AB0 blood groups.

The lyophilisate for the preparation of a solution for infusion should be dissolved in 50 ml of water for injection at a temperature of 35–37 ° C before administration. For thawing, the bag with the frozen solution for infusion must be placed in a water bath also at a temperature of 35–37 ° C. Both dosage forms of Cryoprecipitate at the indicated temperature completely dissolve within 7 minutes. The clear, pale yellow solution obtained after dilution, free from inclusions in the form of flakes, must be used immediately.

It is necessary to inject Cryoprecipitate intravenously (intravenously) slowly using a syringe or a system for transfusing infusion solutions with a disposable filter. The dose of Cryoprecipitate is set depending on the location and nature of bleeding, the initial level of factor VIII in the blood, the presence of a specific inhibitor in the blood, which can significantly weaken the activity of factor VIII, as well as the degree of risk of surgery. The dose of the drug is expressed in units of factor VIII activity.

With hemarthrosis, renal, nose, gingival bleeding, and other frequent complications of hemophilia, as well as with tooth extraction, in order to ensure normal hemostasis, the plasma level of factor VIII should be at least 20% of the activity, with gastrointestinal bleeding, intermuscular hematomas, injuries, fractures - not less than 40%, with the overwhelming majority of surgical interventions - not less than 70%.

The number of doses of Cryoprecipitate required to increase the concentration of factor VIII in the blood to the required level is set taking into account the fact that when the drug is injected in an amount of 1 U per 1 kg of body weight in the blood, the level of factor VIII rises by about 1% according to the formula:

X = (Y × Z) ÷ 100

where X is the dose of Cryoprecipitate, Y is the body weight in kg, Z is the required level of factor VIII in the blood, 100 is the lowest content of factor VIII (in units of activity) in 1 dose.

After complete relief of bleeding in patients with hemophilia, the solution is administered at intervals of 12-24 hours at a dose that allows an increase in the concentration of factor VIII by at least 20% of activity. Such therapy is carried out for several days until the inflammatory changes are completely eliminated or until the hematoma is visually reduced in size.

In the case of surgical interventions, the hemostatic dose of the solution is recommended to be administered 30 minutes before the operation. Against the background of massive bleeding, blood loss is replenished; at the end of the operation, the drug solution is re-injected at a dose corresponding to ½ of the initial one. After the operation, it is required to maintain the factor VIII content within the same limits as during the operation for 3-5 days. In the subsequent postoperative period, to maintain hemostasis, the level of factor VIII can be increased to 20% of activity. The course of hemostatic therapy, as a rule, is 7-14 days and depends on the localization of bleeding, the nature of the surgical intervention, and the reparative characteristics of the tissue.

Side effects

During the administration of Cryoprecipitate, in some cases, paresthesia of the oral mucosa was recorded, which did not require treatment and passed on its own immediately after the completion of the transfusion.

If there is a history of a reaction to transfusion of blood components, the use of the drug can sometimes lead to the appearance of the following undesirable effects: allergic reactions - rash, urticaria, stridor breathing, feeling of squeezing in the chest, lowering blood pressure (BP), anaphylaxis; an increase in body temperature and a slight chill (eliminated by the introduction of antihistamines and calcium preparations); the formation of antibodies to blood coagulation factor VIII.

Overdose

There is no data.

special instructions

Cryoprecipitate is produced from human blood plasma, and therefore, when the drug is administered, there is a risk of infection with hepatitis and other viruses. Any medical condition identified by a physician that is believed to be a source of this drug must be reported to the manufacturer.

It is recommended to monitor the heart rate (HR) before and during the administration of Cryoprecipitate. If a significant increase in heart rate is recorded, the infusion rate should be reduced or the administration of the solution should be suspended / stopped, which usually allows for a quick relief of these symptoms.

During drug therapy, to control the achievement and maintenance of an appropriate concentration of antihemophilic factor (AGF), laboratory studies of the patient's plasma should be carried out at regular intervals. If the required plasma level of AGF is not achieved or bleeding cannot be controlled against the background of an adequate dose, the possibility of the presence of inhibitors detected quantitatively in neutralized antihemophilic units in the total plasma volume or in each ml should be considered. If the content of the inhibitor does not exceed 10 U / ml, if a sufficient dose of AGF is used to neutralize the inhibitor, it is allowed to introduce an additional amount of AGF.

When treating with Cryoprecipitate of hemophilia, it is advisable to combine it with glucocorticosteroid drugs and antifibrinolytics in prophylactic and moderate therapeutic doses.

Against the background of the use of Cryoprecipitate, the threat of thromboembolism, thrombosis, disseminated intravascular coagulation syndrome (DIC), and myocardial infarction increases significantly.

Application during pregnancy and lactation

During pregnancy and lactation, the use of Cryoprecipitate according to indications is allowed only if the intended benefit of treatment for the mother outweighs the possible threat to the fetus / child.

Drug interactions

There is no data.

Analogs

Cryoprecipitate analogs are Hemoktin, Octanate, Beriate, LongEyt, Coate-DVI, Fundy, Immunat, Emoclot D. I., Hemophil M.

Terms and conditions of storage

Keep out of the reach of children. Store the lyophilisate for solution preparation in a place protected from light and moisture, at a temperature of 5–20 ° C, solution for infusion - at a temperature not exceeding −25 ° C.

The shelf life of the lyophilisate is 1 year, the solution is 6 months.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Cryoprecipitate

According to the few reviews of Cryoprecipitate found on medical sites, it is a fairly effective tool used to treat and prevent bleeding in patients with hemophilia, von Willebrand disease, or bleeding of another etiology with a sharp decrease in the plasma level of factor VIII. Experts note that Cryoprecipitate infusions are rarely complicated by any undesirable effects. Some patients indicate the appearance of a burning sensation of the oral mucosa, which disappears after the end of the administration of the solution and does not require treatment.

Price for Cryoprecipitate in pharmacies

There is no reliable information about the price of Cryoprecipitate, since the drug is currently not available in the pharmacy network.

The cost of one of the analogues of the drug - Beriate, a lyophilisate for preparing a solution for intravenous administration, can be 4000 rubles. for 1 bottle containing 500 international units (IU).

Maria Kulkes Medical journalist About the author

Education: First Moscow State Medical University named after I. M. Sechenov, specialty "General Medicine".

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!