Universal reference book for medicines
Name of the preparation: IMMUNATE

Active substance: human coagulation factor VIII

Type: Coagulation factor VIII drug

Manufacturer: BAXTER (Austria)
Composition, form of production and packaging
Lyophilizate for the preparation of a solution for intravenous administration of white or white with a yellowish hue, without foreign particles.
1 f.
clotting factor VIII 1000 IU *
von Willebrand Factor? 500 IU **
Excipients: human albumin, glycine, lysine hydrochloride, sodium chloride, sodium citrate dihydrate, calcium chloride dihydrate.
Solvent: water d / u - 10 ml.
* - Factor VIII activity was determined in accordance with the International Standard (WHO) for factor VIII concentrates.
** - collagen-binding activity of von Willebrand factor was determined in accordance with the Standard of Plasma of the International Standards Committee on Thrombosis and Hemostasis.
Vials (1) complete with a solvent (1 pc.), Kit for dissolving and administering the preparation (needle-filter for transfer, disposable syringe, needle-butterfly for transfusion, sterile needle for injections) - packs cardboard.
Lyophilizate for the preparation of a solution for intravenous administration of white or white with a yellowish hue, without foreign particles.
1 f.
clotting factor VIII 250 IU *
von Willebrand Factor? 125 IU **
Excipients: human albumin, glycine, lysine hydrochloride, sodium chloride, sodium citrate dihydrate, calcium chloride dihydrate.
Solvent: water d / u - 5 ml.
* - Factor VIII activity was determined in accordance with the International Standard (WHO) for factor VIII concentrates.
** - collagen-binding activity of von Willebrand factor was determined in accordance with the Standard of Plasma of the International Standards Committee on Thrombosis and Hemostasis.
Vials (1) complete with a solvent (1 pc.), Kit for dissolving and administering the preparation (needle-filter for transfer, disposable syringe, needle-butterfly for transfusion, sterile needle for injections) - packs cardboard.
Lyophilizate for the preparation of a solution for intravenous administration of white or white with a yellowish hue, without foreign particles.
1 f.
clotting factor VIII 500 IU *
Willebrand Factor? 250 IU **
Excipients: human albumin, glycine, lysine hydrochloride, sodium chloride, sodium citrate dihydrate, calcium chloride dihydrate.
Solvent: water d / u - 5 ml.
* - Factor VIII activity was determined in accordance with the International Standard (WHO) for factor VIII concentrates.
** - collagen-binding activity of von Willebrand factor was determined in accordance with the Standard of Plasma of the International Standards Committee on Thrombosis and Hemostasis.
Vials (1) complete with a solvent (1 pc.), Kit for dissolving and administering the preparation (needle-filter for transfer, disposable syringe, needle-butterfly for transfusion, sterile needle for injections) - packs cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2010.
PHARMACHOLOGIC EFFECT
Immunate is a highly purified lyophilized concentrate of a complex of coagulation factors VIII and Willebrand, prepared from human plasma, twice virusinactivated (treatment with hot steam and solvent-detergent treatment).
The factor VIII complex / vWF consists of 2 molecules, factor VIII (fVIII) and vWF (vWF), with different physiological functions. Activated Factor VIII is a cofactor for the activation of factor IX, which accelerates the transfer of factor X to the activated factor X. Activated factor X is necessary for the conversion of prothrombin to thrombin. Thrombin, in turn, turns fibrinogen into fibrin, and a clot forms. Hemophilia A is a hereditary sex-linked disorder of the blood coagulation system caused by a deficiency of FVIII, which results in profuse bleeding or hemorrhages in the joints, muscles or internal organs as a result of injuries and surgical interventions, and spontaneously. Substitution therapy increases the plasma content of FVIII and thereby temporarily corrects the deficiency of the factor and reduces the tendency to bleeding.
PV, in addition to the function of the protein stabilizing fVIII in plasma, promotes the adhesion of platelets to the site of vascular injury, participates in platelet aggregation and is necessary for replacement therapy in patients with von Willebrand disease.
PHARMACOKINETICS
After the administration of the drug, the increase in the activity of fVIII in plasma is 80-120% of the expected. In pharmacokinetic studies, recovery of FVIII in vivo (recovery) after administration of Immunate averaged about 100%.
The activity of FVIII in blood plasma is reduced by a two-phase exponential curve. In the initial phase, it is distributed between the intravascular bed and extravascular tissue fluids with T 1/2 from the plasma for 3-6 hours; approximately from 2/3 to 3/4 IV of the administered FVIII remains in the vascular bed. The subsequent slow phase may reflect the decay of FVIII. In this phase, T 1/2 is between 8-20 hours, an average of 12 hours. This reflects the true biological T 1/2 FVIII. In the above-mentioned pharmacokinetic studies of Immunate, using the methods of dependent and independent models, the mean value of T 1/2 FVIII was 11 hours.
INDICATIONS
- Treatment and prevention of bleeding in hereditary (haemophilia A) and acquired deficiencies FVIII;
- Willebrand disease with a deficiency of FVIII.
DOSING MODE
The drug after the preparation of the solution is administered iv in slowly. Therapy should begin under the supervision of a doctor with experience in the treatment of hemophilia. Doses and duration of substitution therapy depend on the degree of FVIII deficiency, localization, bleeding intensity and severity of the clinical condition of the patient. The amount of FVIII administered is expressed in International Units (ME), which corresponds to the generally accepted WHO standard for preparations containing FVIII. Plasma FVIII activity is expressed either as a percentage (corresponds to normal human plasma), or in International Units (corresponds to the International Standard for FVIII in plasma).
One International Unit (ME) of FVIII activity is equivalent to the same amount of FVIII in 1 ml of normal human plasma.
A. Dose Calculation for Haemophilia A
The calculation of the required dose of FVIII is based on the empirically established fact that when 1 ME FVIII per kg body weight is administered, the activity of FVIII in plasma increases by 1.5-2% of normal activity. The dose of the drug is calculated by the following formula:
Necessary dose of Immunate (ME FVIII) = body weight (kg) x desired increase in FVIII (in%) x 0.5.
In each specific case, the amount of drug administered and the frequency of administration should be correlated with clinical efficacy.
Bleeding and surgical interventions
In the case of the hemorrhagic episodes listed below, the activity of factor VIII in plasma should not be lower than the recommended level.
Severity of bleeding / volume of surgery Required level of factor VIII in plasma (%) (IU / dL) Multiplicity of administration / duration of therapy
Initial signs of hemarthrosis, hemorrhage in the muscles or bleeding in the mouth 20-40 Repeated IV slow injection every 12-24 hours Not less than 1 day; before the relief of bleeding (as indicated by the absence of pain) or healing.
Pronounced hemarthrosis, muscle hemorrhage or hematoma 30-60 Slow repeated iv injection every 12-24 hours for 3-4 days or more until pain relief and recovery of motor activity are complete.
Life-threatening hemorrhages 60-100 Repeated slow IV injection every 8-24 hours until life threatened.
Small surgical interventions, including extraction of teeth 30-60 Every 24 hours, at least 1 day, until healing.
Large surgical interventions 80-100 (before and after surgery) Repeated slow iv injection every 8-24 h until adequate wound healing, then therapy for at least 7 days to maintain factor VIII activity at 30-60% (IU / dL)
In some cases, especially at the beginning of therapy, it may be necessary to administer the drug at doses higher than calculated.
During the course of treatment it is recommended to determine the activity of FVIII in plasma for the purpose of dose adjustment and frequency of drug administration. Accurate monitoring of substitution therapy based on coagulation data (fVIII activity in plasma) is especially necessary for large surgical interventions. Among patients, individual features of the response to the introduction of FVIII are possible, which is manifested in differences in the rates of in vivo and T 1/2 recovery.
Prolonged prevention
For long-term prophylaxis in severe forms of hemophilia A, doses of 20-40 MB FVIII per kg of body weight are recommended every 2-3 days. In some cases, especially in young patients , it may be necessary to reduce intervals between administrations or increase doses of the drug to prevent hemorrhage.
B. Inhibitory forms of hemophilia A
If it is not possible to achieve the expected increase in factor activity in the patient's plasma or to stop bleeding by administering the calculated doses of the drug, a study should be conducted for the presence of inhibitors to FVIII. In patients with a titer of inhibitors below 10 Bethesda Units (BY) per 1 ml, the inhibitor can be neutralized by the additional administration of human FVIII. In patients with an inhibitor titer above 10 BTU / ml or with a high response in the history (high-responders), it is usually not possible to effectively control bleeding with the introduction of FVIII. In these cases, appropriate special anti -inhibitory therapy should be given. Such therapy should be carried out exclusively by physicians with experience in the treatment of patients with hemophilia.
C. Willebrand disease with factor VIII deficiency
Immunate is indicated as a substitution therapy for patients with von Willebrand disease with reduced factor VIII activity. Substitution therapy Immunomat for the purpose of stopping and preventing bleeding associated with surgical interventions is carried out in accordance with the recommendations for patients with hemophilia A.
Preparation of the drug solution
The Immunate solution is prepared immediately before the introduction. The prepared solution retains its chemical and physical stability for 3 hours at a temperature of 20-25 ° C; however, it should be used immediately after preparation, since it does not contain preservatives. The user is responsible for the conditions and duration of storage of the prepared solution. Do not use a turbid solution or solution with inclusions. Unused solution is to be disposed of properly.
1. Heat the vial with the solvent (sterile water for injection) to room temperature (no higher than 37 ° C).
2. Remove the protective caps from the flasks with concentrate and solvent and disinfect the rubber stoppers of both bottles.
3. Install and then press the wavy edge of the system onto the solvent bottle.
4. Remove the protective cap from the other end of the transfer system. Do not touch the bare end of the system.
5. Flip the solvent bottle over the flask with a dry concentrate and pierce the center of the vial with the free end of the needle. Due to the vacuum, the solvent will flow into the vial with the drug. Wait approximately 1 min.
6. Disconnect the vials by pulling the needle of the system to transfer from the vial of the vial to the drug. Because the drug dissolves easily, slightly - if necessary - shake the bottle. Do not shake the bottle with the drug. Do not turn over the vial of the drug until its contents are withdrawn.
7. Preparations for parenteral administration, such as Immunat, should be visually inspected for inclusions and discoloration after preparation and before administration. Even if the instructions for preparing the solution are carefully observed, small particles can occasionally be seen. They are removed by the supplied filter. The concentration of the pharmaceutically active ingredient indicated on the label is not reduced.
Introduction
1. When collecting the prepared solution in a syringe, use the supplied filter needle to avoid particles of the rubber plug (risk of microembolism). Install the filter needle on the supplied disposable syringe and pierce it with a rubber stopper.
2. Remove the syringe from the filter needle for a short time. The air will get inside the vial with the solution and will precipitate the formed foam. Then, draw the solution through the filter needle into the syringe.
3. Remove the syringe from the filter needle and inject the IV solution slowly (maximum injection rate is 2 mL / min) using the supplied system or the supplied disposable needle.
SIDE EFFECT
In response to the introduction of preparations of factor VIII, extremely sensitive reactions or allergic reactions (including angioedema, burning sensation at the injection site, skin hyperemia, urticaria, pruritus, chills, headache, arterial hypotension, drowsiness, nausea, vomiting, restlessness, tachycardia, a feeling of compression in the chest, breathy breathing) until the development of an allergic shock. In rare cases, an increase in body temperature is possible.
Patients with hemophilia A can develop antibodies to factor VIII (inhibitors), which is clinically manifested by the absence of haemostatic effect in response to ongoing therapy. In such cases, the patient should be counseled in a specialized hemophilic center.
There are currently no confirmed clinical data on the use of Immunate in previously untreated patients (PUPs), so these patients should be carefully screened for the presence of inhibitors by appropriate methods (Bethesda test).
In response to the introduction of high doses in patients with blood groups A (II), B (III) or AB (IV), hemolysis may occur.
CONTRAINDICATIONS
- Hypersensitivity to the components of the drug.
PREGNANCY AND LACTATION
Controlled studies confirming the safety of the use of coagulation factor VIII concentrates in pregnancy and lactation were not conducted. Therefore, during pregnancy and lactation, the drug should be administered only on strict indications.
APPLICATION FOR CHILDREN
It should be used with caution in children under 6 years of age who are rarely treated with fVIII.
SPECIAL INSTRUCTIONS
The development of allergic reactions is possible, as well as on / in the administration of any protein preparations. In these cases, the drug should be discontinued immediately and treated depending on the reaction and its severity. In light reactions, anti-shock drugs are prescribed, in severe cases, anti-shock therapy is administered.
Immunate is produced from human plasma. When using plasma or products made from human plasma, the risk of transmission of infectious agents can not be completely excluded, including. not yet known. However, the risk of transmission of infectious agents is maximally reduced, thanks to the following measures:
- a thorough medical examination and selection of donors and screening of individual doses and pools of plasma for HbsAg and antibodies to HIV and hepatitis C;
- research of plasma pools on the genomic sequences of the hepatitis C virus;
- inclusion in the process of production of treatment with hot steam and solvent-detergent treatment for the purpose of removing / inactivating viruses, the effectiveness of which has been proved on virus-models. The effectiveness of these methods with respect to HIV-1, HIV-2, hepatitis C, A and B was confirmed.
The virus removal / inactivation methods used in the manufacturing process can be partially effective for some non-enveloped viruses, such as parvovirus B19. Infection caused by parvovirus B19 can lead to a serious illness in pregnant women (fetal infection) and in patients with immunodeficiency or increased disintegration of erythrocytes (eg, in hemolytic anemia).
When treating with plasma concentrates FVIII recommended appropriate vaccination of patients (against hepatitis A and B).
In the treatment of patients with hemophilia A, it is possible to develop such complications as the appearance of neutralizing antibodies (inhibitors) to factor VIII. These inhibitors belong to the class of immunoglobulins G. They are directed against procoagulant activity of factor VIII and are measured in Bethesda Units (BY) per 1 ml of plasma (modified Bethesda method). The risk of developing inhibitors correlates with the use of human fVIII preparations, the greatest risk of development of inhibitors is the first 20 days of drug administration. Rarely, inhibitors can be formed after the first 100 days of treatment. For timely detection of inhibitors, careful clinical observation and laboratory examination of patients treated with human fVIII concentrates should be performed.
It should be used with caution in children under 6 years of age who are rarely treated with fVIII.
The sodium content in the maximum daily dose of the drug is 200 mg, which should be taken into account in individuals on a hypo-and salt-free diet.
Impact on the ability to drive vehicles and manage mechanisms
Immunate has no effect on the ability to drive and perform work that requires increased concentration of attention and motor reaction.
OVERDOSE
Symptoms of an overdose of preparations of the coagulation factor VIII of man are unknown.
DRUG INTERACTION
The interaction of drugs with human v3III with other drugs is unknown.
Before administration Immunat should not be mixed with other drugs, which can worsen the effectiveness and safety of the drug.
It is desirable to wash the common venous access with an isotonic (physiological) solution of sodium chloride before and after administration of the Immunate.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
List B. The drug should be stored out of reach of children at a temperature of 2 ° to 8 ° C. Shelf life - 2 years.
The chemical and physical stability of the finished solution for the on / in the persists for 3 hours at a temperature of 20-25 ° C.
From a microbiological point of view, the formulation may include the risk of microbial contamination, the drug should therefore be used immediately after reconstitution.
If the finished product solution is not used immediately, the responsibility for the time and conditions of storage of the user.
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