Coagulation factor VIII (antihemophilic factor): general information. Association of plasma factor VIII levels with the severity of the bleeding disorder

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Blood is one of essential parts human body. This liquid substance nourishes all the organs and tissues of our body. Normally, in an adult in the body from 3500 to 5000 ml of blood. And in order to maintain this amount, nature provides for the process of stopping blood during injuries. Consider the clotting factors. and what significance it has for human life.

What is hemostasis

In our body, blood must be maintained in a liquid state in order to provide all organs and tissues with the necessary nutrients and oxygen. At the same time, if necessary, the liquid substance must turn into a jelly-like substance so that the person does not die from blood loss. And after the jelly-like thrombus has fulfilled its mission, it must again take liquid state. This process of regulating the state of the blood is called hemostasis.

Hemostasis is very complex mechanism, which involves dozens of substances. If this process fails, a person may face many diseases that are life-threatening. Hemostasis is influenced by clotting factors in the blood.

Coagulation

Coagulation or is defense mechanism body from massive blood loss. Today, about half of humanity has problems with coagulation. It is because of them that such terrible diseases like thrombosis, heart attack, stroke, major bleeding. Every tenth person dies as a result untimely treatment these blood pathologies, and every second person does not suspect the presence of a coagulation disorder at all.

Coagulation is a sequential series of processes, each of which triggers the next. In case of failure at any stage of clotting, a pathology occurs that prevents normal blood clotting. Today, scientists have identified the main phases of blood coagulation, these are:

• The appearance of prothrombin.
• The occurrence of thrombin.
• fibrin activation.

The last phase of bleeding arrest is the narrowing and dissolution of the thrombus, which goes into the original liquid state.

Factors affecting coagulation

Two main categories of molecules are responsible for blood clotting in our body - plasma and platelet. Plasma hemostasis occurs with the participation of proteins that are involved in the formation of a blood clot. How many factors affect hemostasis? The table of plasma factors consists of 13 elements, which are indicated in medicine by Roman numerals.

Each of these components plays a role in the formation of fibrin.

In addition to the numbered coagulation factors, there are several other auxiliary plasma substances that are responsible for the reaction of all components.

Platelet coagulation factors are components of platelets that are related to the components that are responsible for the clotting of red blood cells. There are 10 of them in medicine. With a lack or excess of one of the components, coagulation fails and the blood coagulates more slowly than normal.

13 plasma factors

Also, additional plasma coagulation factors take part in coagulation.

Coagulation factors in the blood include components: Willebrand, Fletcher, Fitzgerald. These components are involved in the activation of other factors, and if they are deficient, the coagulation chain may be disrupted.

Deficiency of one or more clotting factors leads to the development of a pathology called coagulopathy, which is a violation of blood clotting. Coagulopathy can be caused by both hereditary and acquired causes. Hereditary factors in the development of the disease include:

• Deficiency of components 8 and 9, 10 factors.
• Deficiency of components 5, 7, 10 and 11 factors.
• Deficiency of components of other factors.

Acquired Factors:

• ICE syndrome.
• Acquired inhibitors.
• Deficiency of prothrombin factors.
• Heparin preparations, etc.

Platelet factors

Platelet coagulation factors in the blood are found directly in platelets - red blood cells. Today, scientists say that their number exceeds 10, but exact number is still in question. Medical textbooks today list 12 blood clotting molecules:

• thrombin protein.
• Trigger fibrin accelerator.
• Phospholipoprotein.
• Heparin inhibitor.
• Agglutinabelin.
• fibrin breakdown inhibitor.
• Inhibitor of the breakdown of prothrombin.
• Retractosin.
• Serotonin.
• Cotromboplastin.
• fibrin activator.
• ADP is responsible for the adhesion of platelets.

Factors affecting blood clotting

In order to maintain their health in order, each person must know the factors that accelerate and slow down blood clotting. This knowledge will help to avoid the development of life-threatening conditions and to establish a coagulation system in a timely manner. Violation of hemostasis at any stage can lead either to extensive bleeding or to the formation of blood clots. Both are life threatening.

Low blood clotting. This condition is dangerous with the occurrence of fatal internal bleeding. The reasons for the development of pathology can be:

• Genetic disorders.
• Oncological diseases at a late stage.
• Blood thinners.
• Vitamin K deficiency.
• Lack of calcium.
• Liver diseases.

Treatment of this pathology depends on the causes of its development. The drugs are prescribed by a hematologist. If the cause of poor clotting was drug treatment, you need to limit the intake of drugs or replace them with more gentle drugs.

This pathology is dangerous by the formation of blood clots in blood vessels, veins and arteries. When the arteries are clogged, the organs that it nourishes die off. Also, the danger lies in the possibility of a blood clot breaking off, which can clog the vital arteries of the lungs and heart, this leads to lethal outcome. The main reasons for the development of this disorder are:

• Infectious diseases.
• Low physical activity.
• Atherosclerosis.
• Dehydration.
• hereditary factors.
• Diabetes.
• Excess weight.
• Pregnancy.
• Autoimmune diseases.
• Stress.
• Oncological diseases.

In the treatment of this pathology main goal doctors is to reduce blood clotting to normal level. For these purposes, special preparations are used - anticoagulants. Their reception should take place under the strict supervision of the attending physician. First, the patient is prescribed a course of heparin, and then aspirin therapy is performed.

In hereditary thrombophelia, aspirin is prescribed in small doses as early as infancy.

A blood clotting function test should be performed before any surgical intervention to rule out possible complications. Also, this study is prescribed for pregnant women and for certain complaints of patients. Usually increased clotting observed in elderly patients.

If you are diagnosed with a bleeding disorder, there is no need to panic. This means that you need to take better care of your health. Any medicine should be taken only after consulting a doctor. It is also necessary to take all the tests to find out the cause of the violation. If you do not delay treatment and follow all the doctor's recommendations, the disease will quickly subside and your life will return to a healthy course.

In contact with

Coagulation factor VIII ( Coagulation Factor VIII)

Clinical and pharmacological group

A drug factor VIII blood clotting

pharmachologic effect

hemostatic drug. Promotes the transition of prothrombin to thrombin and the formation of a fibrin clot.

Pharmacokinetics

In patients with hemophilia, A T 1/2 is 12 hours. The activity of blood coagulation factor VIII decreases by 15% within 12 hours. Blood coagulation factor VIII is thermolabile and is rapidly destroyed when the temperature rises, which leads to a decrease in T 1/2.

Dosage

Octanate is administered intravenously after dilution with water for injection, which is included in the package. Octanate dose and duration replacement therapy depend on the degree of deficiency of blood coagulation factor VIII, the location and duration of bleeding, clinical condition patient.

The dose of the drug is expressed in International Units (IU) in accordance with the accepted WHO standards for blood coagulation factor VIII. The activity of blood coagulation factor VIII in plasma is expressed either as a percentage (relative to the normal content of the factor in human plasma), or in IU (relative to International Standard for coagulation factor VIII).

1 IU of coagulation factor VIII is equivalent to 1 ml of normal human plasma. The calculation of the required dose is based on empirical results, according to which 1 IU / kg of blood coagulation factor VIII increases the level plasma factor 1.5-2% of the normal content. To calculate the dose required for the patient, the initial level of activity of blood coagulation factor VIII is determined and it is estimated by how much this activity needs to be increased.

Required dose = body weight (kg) × desired increase in clotting factor VIII (%) (IU/dl) × 0.5.

The amount and frequency of use of the drug should always correspond to the clinical effectiveness in each individual case.

In the event of subsequent bleeding, the level of blood coagulation factor VIII activity should not decrease below the initial plasma level (% of normal content) in the appropriate period of time. The following table can be used as a guideline for choosing the dose of coagulation factor VIII for various bleeding and surgical interventions.

Patients respond to the administration of the drug individually, while there is different level recovery in vivo, T 1/2 coagulation factor VIII is characterized by variability. Therefore, during treatment, to regulate the dose and frequency of administration, its level should be monitored. The activity of blood coagulation factor VIII should be monitored during replacement therapy, especially during major surgical interventions.

The doses indicated in the table are indicative. The doctor sets the required dose and frequency of use of the drug individually.

With the aim of long-term prevention bleeding in severe hemophilia A the drug is prescribed at a dose of 20-40 IU / kg of body weight every 2-3 days. In some cases, especially in young patients, it may be necessary to reduce the interval between injections or increase the dose.

Some patients may develop after treatment inhibitory antibodies to coagulation factor VIII, which may affect the effectiveness further treatment. If, against the background of ongoing therapy, the expected increase in factor VIII activity is not noted or the required hemostatic effect is absent, consultation with a specialist is recommended. treatment center using the Bethesda test. Immune tolerance induction therapy can be used to eliminate an inhibitor to coagulation factor VIII. Its basis is the daily administration of blood coagulation factor VIII at a concentration exceeding the blocking ability of the inhibitor (100-200 IU/kg/day, depending on the inhibitor titer). Blood coagulation factor VIII, acting as an antigen, provokes an increase in the inhibitor titer until tolerance develops, i.e. until the decrease and subsequent disappearance of the inhibitor. Therapy is continuous and lasts an average of 10 to 18 months. Such treatment should only be carried out by specialists in the field of antihemophilic therapy.

Dissolution of the lyophilisate

1. The solvent (water for injection) and lyophilizate in closed vials are recommended to be brought to room temperature. If before warming the solvent is used water bath, care should be taken to ensure that water does not come into contact with rubber stoppers or vial caps. The temperature of the water bath should not exceed 37°C.

2. Remove the protective caps from the bottles with lyophilisate and water, disinfect the rubber stoppers of both bottles with one of the disinfectant wipes.

3. Release the short end of the double-ended needle from the plastic packaging, pierce the stopper of the water bottle with it and push it down until it stops.

4. Turn the bottle of water over with the needle, release the long end of the double-ended needle, pierce the stopper of the vial with lyophilisate with it and press down until it stops. The vacuum in the lyophilisate vial will draw in the water.

5. Separate the bottle with water together with the needle from the bottle with lyophilisate. The drug will dissolve quickly; to do this, the bottle must be slightly shaken. Only a colorless, transparent or slightly opalescent solution without sediment is allowed for use.

Rules for the preparation and administration of the solution

As a precautionary measure, heart rate should be monitored before and during the administration of Octanate. In the case of a pronounced acceleration of the pulse, slow down or stop the administration of the drug.

After dissolving the concentrate according to the instructions, remove the protective coating from the filter needle and insert it into the bottle with the concentrate. Remove the cap from the filter needle and attach the syringe. Turn the vial with the syringe upside down and draw the solution into the syringe. Injections should be carried out in accordance with the rules of asepsis and antisepsis. Disconnect the filter needle from the syringe and attach the butterfly needle instead.

The solution should be administered intravenously slowly at a rate of 2-3 ml / min.

If more than one bottle of Octanate is used, the syringe and butterfly needle can be reused.

The filter needle is for single use only. Always use a needle with a filter to draw the prepared solution into the syringe.

Any unused solution of the drug should be disposed of in accordance with existing regulations.

Overdose

Despite the fact that symptoms of an overdose of factor VIII were not observed, it is recommended not to exceed the prescribed dose.

drug interaction

Data on the interaction of Octanate with others medicines missing.

Pregnancy and lactation

The use of the drug during pregnancy and lactation is possible in cases where the expected benefit of therapy for the mother exceeds potential risk for a fetus or an infant.

Side effects

Allergic reactions: rarely - angioedema, burning sensation in the injection area, chills, hot flashes, urticaria (including generalized), headache, decrease in blood pressure, lethargy, nausea, vomiting, anxiety, tachycardia, feeling of pressure chest, shortness of breath, fever, feeling of shivering. Very rarely (<1/10 000) эти симптомы могут прогрессировать до развития тяжелой анафилактической реакции, включая шок.

Patients with hemophilia A may develop antibodies (inhibitors) to blood coagulation factor VIII (<1/1000). Наличие ингибиторов приводит к неудовлетворительному клиническому ответу на введение препарата. В таких случаях рекомендуется обращаться в специализированные гематологические/гемофильные центры. Неоходимо обследовать пациента на наличие антител с помощью соответствующих методов (тест Бетезда).

Terms and conditions of storage

The drug should be stored in a place protected from light and out of the reach of children at a temperature of 2 ° to 25 ° C; do not freeze. Shelf life - 3 years.

special instructions

When using the drug, the development of hypersensitivity reactions is possible, as with the use of other injectable drugs of protein origin.

In addition to blood coagulation factor VIII, the drug also contains trace amounts of other blood proteins. Early signs of hypersensitivity reactions are hives, chest tightness, shortness of breath, low blood pressure, and anaphylaxis (a severe allergic reaction). If these symptoms occur, the administration of the drug should be stopped immediately. In case of shock development, modern methods of anti-shock therapy should be used.

In the case of medicinal products derived from human blood or plasma, the possibility of transmission of infectious agents cannot be completely excluded. This also applies to pathogens of unknown diseases. However, the risk of transmission of infectious agents is reduced through the following measures:

- selection of donors through medical interviews and examinations, as well as screening of plasma pools for the presence of hepatitis B virus (HBV) antigens, antibodies to HIV and hepatitis C virus (HCV);

— analysis of plasma pools for the presence of HCV genetic material;

— inactivation/removal procedures included in the manufacturing process that have been validated in a viral model. These procedures are effective for HIV, hepatitis A virus (HAV), HBV, and HCV. Inactivation/removal procedures may be of limited effectiveness against non-enveloped viruses, one of which is parvovirus B19. Parvovirus B19 can cause serious reactions in seronegative pregnant women (intrauterine infection) and in people who are immunocompromised or have an increased production of red blood cells (for example, with hemolytic anemia).

When administering plasma-derived coagulation factor VIII concentrate, vaccination against hepatitis A and hepatitis B is recommended.

In the event of allergic reactions, the patient should be examined for the presence of an inhibitor. Patients with inhibitors of blood coagulation factor VIII may increase the risk of anaphylactic reactions during subsequent treatment with Octanate. Therefore, the first use of the specified drug according to the prescription of the attending physician should be carried out under medical supervision in conditions that ensure the provision of qualified medical care in case of allergic reactions.

Do not use other drugs during the administration of Octanate.

For the introduction of Octanate, only the injection devices included in the package should be used. On the inner surface of some injectable devices, adsorption of blood coagulation factor VIII is possible, which leads to a decrease in the effectiveness of treatment.

Application in childhood

Application is possible according to the dosing regimen.

Introduced for the first time

PHARMACOPIES AUTHORIZATION

This Pharmacopoeia Monograph covers preparations of human blood coagulation factor VIII obtained from human blood plasma for fractionation.

Human blood coagulation factor VIII is a preparation of a protein fraction of human blood containing the glycoprotein complex of blood coagulation factor VIII and, depending on the method of preparation, various amounts of von Willebrand factor.

The activity of the drug after reconstitution under the conditions indicated on the label must be at least 20 IU of factor VIII in 1 ml.

PRODUCTION

For the production of human blood coagulation factor VIII preparations, the blood plasma of healthy donors is used that meets the requirements of the FS “Human Plasma for Fractionation”. The production technology includes the stages of removal or inactivation of infectious agents. If chemical compounds are used in production to inactivate viruses, their concentration should be reduced to a level that does not affect the safety of the drug for patients. No antimicrobial preservatives are used in the manufacturing process. The drug may contain stabilizers (albumin, polysorbate, sodium chloride, sodium citrate, calcium chloride, glycine, lysine, etc.). The drug solution is aseptically packaged into primary packaging by sterilizing filtration, lyophilized and sealed under vacuum or in an inert gas atmosphere.

TESTS

Description

White or pale yellow powder or fluffy solid. The determination is carried out visually.

Authenticity

species specificity

Confirm by the presence of only human serum proteins. The test is carried out by gel immunoelectrophoresis using sera against human, bovine, equine and porcine serum proteins in accordance with. It is permissible to conduct a gel immunodiffusion test in accordance with. As a result of the test, precipitation lines with only serum against human serum proteins should be detected.

FactorVIII

Confirm by the presence of factor VIII activity. The test is carried out by the chromogenic or coagulometric method. The determination is carried out in accordance with.

Time to receive reconstituted drug

No more than 10 minutes (if there are no other indications in the regulatory documentation). A description of the procedure is given, indicating the solvent used, its volume and dissolution conditions (solvent temperature, need for mixing, etc.).

Water

No more than 2%. The determination is carried out by the method of K. Fisher in accordance with (if there are no other instructions in the regulatory documentation). The method of determination and the amount of sample required for testing are indicated in the regulatory documentation.

Mechanical inclusions

Visible mechanical inclusions should be absent. The determination is carried out in accordance with. The regulatory documentation indicates the name of the solvent, describes the method of recovery and (if necessary) preparation of the drug.

pH

From 6.5 to 7.5. The determination is carried out by the potentiometric method in accordance with.

Osmolality

Not less than 240 mOsm/kg. The determination is carried out in accordance with.

Protein

The quantitative content of protein per vial or ml of the reconstituted solution is indicated in the regulatory documentation. The determination is carried out in accordance with.

coagulation factor activityVIII

The activity of blood coagulation factor VIII per vial or ml of the reconstituted solution is indicated in the regulatory documentation. The determination is carried out by the coagulometric method in accordance with.

Willebrand factor

The activity of the von Willebrand coagulation factor per vial or ml of the reconstituted solution is indicated in the regulatory documentation. The determination is carried out by the agglutination method or the enzyme immunoassay method in accordance with.

Stabilizer(s)

Quantitative determination of the stabilizer(s) introduced into the preparation is carried out in accordance with and / or, if there are no other indications in the regulatory documentation.

The permissible limit of the content of the stabilizer(s) must be specified in the regulatory documentation.

Virusinactivating agents

Carry out a quantitative determination of the residual content of the virus-inactivating agent(s) in the preparation in accordance with and / or, if there are no other indications in the regulatory documentation. The permissible limit for the content of the virus-inactivating agent(s) should be specified in the regulatory documentation.

Sterility

The drug must be sterile. The test is carried out in accordance with.

Pyrogenicity or bacterial endotoxins

Must be pyrogen-free or contain bacterial endotoxins in an amount not exceeding 0.03 EU per 1 IU of blood coagulation factor VIII activity.

The test is carried out in accordance with (test dose - not less than 50 IU of blood coagulation factor VIII per 1 kg of animal weight) or in accordance with the method specified in the regulatory documentation.

Virus safety

Hepatitis B surface antigen (HBsAg)

The drug should not contain the surface antigen of the hepatitis B virus. The determination is carried out by the enzyme immunoassay using test systems approved for use in Russian healthcare practice and having a sensitivity of at least 0.1 IU/ml in accordance with the instructions for use.

Antibodies to hepatitis C virus

Antibodies to the hepatitis C virus should be absent. The determination is carried out by enzyme immunoassay using test systems approved for use in Russian healthcare practice and having 100% sensitivity and specificity in accordance with the instructions for use.

Antibodies to human immunodeficiency virus (HIV-1 and HIV-2)and HIV-1 p24 antigen

The drug should not contain antibodies to the human immunodeficiency virus (HIV-1 and HIV-2) and HIV-1 p24 antigen. The determination is carried out by enzyme immunoassay using test systems approved for use in Russian healthcare practice and having 100% sensitivity and specificity in accordance with the instructions for use.

Packageand labeling

X wound

Store in a place protected from light at a temperature of 2 to 8 ° C, unless otherwise indicated in the regulatory documentation.

Chromatographically purified lyophilized human plasma fraction containing factor VIII coagulation blood. Antihemophilic globulin, compensates for the deficiency of coagulation factor VIII, temporarily compensates for the coagulation defect in patients with hemophilia A. It is found in natural combination with protein C of factor VIII, von Willebrand factor. It is involved in the processes of blood coagulation, promotes the transition of prothrombin to thrombin and the formation of a fibrin clot. Immediately after administration, it increases the coagulation potential of the blood. The decrease in the activity of the antihemophilic factor has a two-phase character: the early phase is a rapid decrease in activity, characterizes the time of equilibration with the extravascular space, the second phase is slow, reflects the biological half-life of the administered antihemophilic factor and is 9-14 hours. Specific activity (after the addition of human albumin) - 9-22 IU of protein. 1 IU (as defined by the WHO blood coagulation factor VIII standard) is approximately equal to the level of antihemophilic factor present in 1 ml of fresh human donor plasma.
The time to reach the maximum plasma concentration after intravenous administration is from 10 minutes to 2 hours. The half-life is 8.4-19.3 hours. The activity of coagulation factor VIII decreases gradually - by 15% within 12 hours. With hyperthermia, the period the half-life of coagulation factor VIII may decrease.

Indications for use of the drug Coagulation Factor VIII

Hemophilia A, von Willebrand's disease (treatment and prevention of bleeding, including during surgical interventions); acquired deficiency of factor VIII, diseases accompanied by the formation of antibodies to factor VIII.

How to use Coagulation Factor VIII

In / in. For the prevention of spontaneous bleeding or with light bleeding - 10 IU / kg (the content of factor VIII, necessary to prevent spontaneous bleeding - 5% of the normal level); with moderate bleeding and a small surgical intervention (for example, tooth extraction) - 15-25 IU / kg (factor VIII content - 30-80% of the norm) followed by a maintenance dose of 10-15 IU / kg every 12-24 hours for 3 days or until a sufficient clinical effect is obtained; in acute life-threatening bleeding - 40-50 IU / kg (factor VIII content - 60-100% of the norm) followed by a maintenance dose of 20-25 IU / kg every 8-24 hours; with extensive surgical interventions - 40-50 IU / kg 1 hour before the procedure and 20-25 IU / kg - 5 hours after the first dose (that is, 80-100% of the norm before and after surgery), then repeat every 8-24 h until a sufficient clinical effect is obtained. For long-term prevention of bleeding in severe hemophilia A - 12-25 IU / kg every 2-3 days.
Cryoprecipitate is used taking into account compatibility for AB0 blood groups. A container with frozen cryoprecipitate is placed for thawing and complete dissolution in a water bath at a temperature not exceeding 35-37 ° C and incubated for no more than 7 minutes. The resulting transparent yellowish solution, which should not contain flakes, is used immediately after preparation. Administered intravenously with a syringe or transfusion system with a disposable filter. The dose depends on the initial content of factor VIII in the blood of a patient with hemophilia, the nature and localization of bleeding, the degree of risk of surgical intervention, the presence in the patient's blood of a specific inhibitor that can neutralize the activity of factor VIII (expressed in units of factor VIII activity). To ensure effective hemostasis in the most common complications of hemophilia (hemarthrosis, renal, gingival and nasal bleeding), as well as tooth extraction, the content of factor VIII in plasma should be at least 20%; with intermuscular hematomas, gastrointestinal bleeding, fractures and other injuries - not less than 40%; in most surgical interventions - at least 70%. With the introduction of factor VIII at the rate of 1 unit per 1 kg of body weight, its content in the blood increases by an average of 1%. Based on this, the number of doses required to increase the concentration of factor VIII in the blood to a given level is calculated by the formula: the patient's body weight (in kg) multiplied by the required content of factor VIII in the patient's blood and divided by 200 (the minimum content of factor VIII in units of activity in 1 dose of cryoprecipitate). After a complete stop of bleeding, the introduction of factor VIII to patients with hemophilia is carried out at intervals of 12-24 hours at a dose that provides an increase in the content of factor VIII by at least 20%. Treatment is continued for several days - until a visible decrease in the size of the hematoma. In surgical interventions, a hemostatic dose is administered 30 minutes before surgery. In case of massive bleeding, blood loss is replenished, at the end of the operation, cryoprecipitate is re-introduced (1/2 dose from the original). 3-5 days after the operation, it is necessary to maintain the concentration of factor VIII in the patient's blood within the same limits as during the operation. In the postoperative period in the future, to maintain hemostasis, it is enough to increase the content of factor VIII to 20%. The duration of hemostatic therapy is 7-14 days and depends on the nature, location of bleeding, reparative tissue characteristics. It is advisable to combine the treatment of a patient with hemophilia with cryoprecipitate with the simultaneous administration of antifibrinolytic agents and corticosteroids in prophylactic and medium therapeutic doses.

Contraindications to the use of the drug Coagulation Factor VIII

Increased sensitivity.

Side effects of clotting factor VIII

Allergic and transfusion reactions (urticaria, rash, stridor breathing, decreased blood pressure, chills, hyperthermia, anaphylaxis), transient paresthesia of the oral mucosa, nausea, vomiting, headache.

Special instructions for the use of the drug Coagulation Factor VIII

Use with caution during pregnancy and lactation.
It is necessary to control the heart rate before and during therapy: with a significant increase in heart rate, the infusion rate is slowed down or the administration is stopped. During and after the end of the course of therapy, it is necessary to control the content of factor VIII in the blood. To identify signs of progressive hemolytic anemia, it is necessary to monitor hematocrit and direct Coombs reaction. Changes in the immune status in patients with asymptomatic hemophilia are due to repeated exposure to viral pathogens and / or the possible presence of impurities in factor VIII preparations (for example, IgG). In order to achieve satisfactory clinical results, an additional dose may be administered in addition to the initially calculated dose. In the absence of a clinical effect, it is necessary to conduct a test to identify the inhibitor and determine its amount in neutralized antihemophilic units per 1 ml or total plasma volume. To reduce the risk of side effects, it is recommended to use no later than 1 hour after dilution, administer only intravenously, for at least 3 hours (at a rate of 10 ml / min), do not freeze the solution and do not reuse. It is possible to develop antibodies to coagulation factor VIII, in such cases the effectiveness of therapy is usually reduced, which may require an increase in the dose of coagulation factor VIII. It is possible to increase the rate of decline in CD4 cell counts in HIV-seropositive patients with hemophilia.