- 450 ME human coagulation factor VIII;
- 400 ME von Willebrand factor;
- 7.5 mg protein;
- additional ingredients (glycine, sucrose, sodium chloride, calcium chloride, sodium citrate, polysorbate 80, water).
Also, the drug is produced in a dosage:
- 900 IU of human coagulation factor;
- 800 ME von Willebrand factor;
- 15 mg protein;
The product is released in powder form or amorphous mass white or yellow. In conjunction with lyophilisate there is a solvent and a kit for intravenous administration, one bottle in a cardboard bundle.
Pharmacodynamics and pharmacokinetics
The drug is intended for the regulation of blood coagulation processes. In particular, when von Willebrand disease and hemophilia A. Von Willebrand factor allows you to adjust hemostatic disorders that are found in patients with deficiency of von Willebrand factor.
The mechanism of action of the factor is made at two levels:
- is recovering platelet adhesion to vascular subendothelium in the place of damage to the vessel, primary hemostasis, bleeding time is quickly reduced;
- there is also a delayed deficit correction associated with factor 7by binding to endogenous factor 7and stabilization of its structure.
Also optional von Willebrand factor able to amplify and accelerate platelet adhesion generally.
The effect of the drug on the patient suffering hemophilia A occurs due to the joint work of two factors. They communicate with each other. Activated factor 7 is an cofactor for 9 (9a), which accelerates the conversion of the 10th to 10a factor. The last link in this chain turns prothrombin at thrombin. Thrombin, in turn, is involved in transition reactions fibrinogen fibrin thrombus.
Thus, the tool significantly reduces the risk of development bleeding, restoring optimal levels of factors that are involved in the process of blood coagulation.
The active ingredients of Vilate are the natural components of the blood of a healthy person. After administration, they remain in the body for some time, maintaining their activity.
Indications for use
The drug is prescribed:
- for the prevention and treatment of bleeding, including during surgical operations with von Willebrand diseaseif application desmopressin contraindicated or not effective enough;
- for the treatment or prevention of bleeding in congenital deficiency factor 7(hemophilia A).
Due to the fact that there is insufficient data on the use of the drug in children under 6 years of age, it is not recommended to use the drug on this group of patients.
The drug is contraindicated in the presence of reactions hypersensitivity to its components.
Among the side effects, the most likely allergic reactions:
- tingling at the injection site, chills, hyperemiaskin rashes, headache, angioedema;
- lethargy and strong decline HELL, tachycardianausea, tinnitus, wheezing;
rarely observed fever and very rarely anaphylactic shock.
There is a risk of thrombosis. It is necessary to carry out monitoring in the early stages and to start prevention on time thromboembolism in accordance with the recommendations.
In patients suffering von Willebrand diseasevery rarely can be produced antibodiesneutralizing specific von Willebrand factor. In this case, an inadequate reaction to the administration of the drug is possible, up to anaphylactic shock. As a therapy, it is recommended to contact a special research center hemophilia.
Instructions for use Vilate (method and dosage)
Treatment and administration of the drug is carried out under the supervision of a doctor who has experience in this field.
The medicine is intended for single use. If the agent was not fully administered, its residues should be disposed of.
A suitable dosage should be selected depending on the weight of the patient and the type of bleeding.
Vilate injected intravenously after preparing the solution.
As a rule, to achieve the necessary activity of blood proteins, it is enough to enter from 20 to 50 ME per kilogram of patient’s body weight.
The initial dose is about 65 ME per 1 kg of weight. It should be remembered that for certain types of diseases, for example von Willebrand disease type 3 or with bleeding in Gastrointestinal tracthigher dosages are required.
Instructions for use in surgical interventions, injuries, for the prevention of bleeding
About half an hour before the start of the operation, a medicine should be administered. If the surgery was planned earlier, then the time interval should be increased to 12 hours or one day (additionally enter one hour before the operation). The optimal level to be achieved is FV: RK≥60 ME/ dl, for FVIII - C ≥50 ME/ dl.
To maintain the condition, such a dose is administered every 12 hours or one day if necessary. Two days later to prevent thrombosis, the dosage must be reduced or the interval between injections should be increased.
The use of Vilate in hemophilia A
Dosage and duration of treatment depends on the condition of the patient, the degree of anemia, the duration of bleeding. The right amount is measured in ME (international unit). One ME is the amount of factor 7 in 1 ml of healthy human plasma.
To calculate the required dosage of the drug, you need to multiply the patient’s mass by the desired level increase F7(%) and 0.5 ME/ kg
Depending on the strength of the bleeding and its type, there is a certain frequency of administration of the drug and the necessary F7.
- With moderate blood loss (early hemarthrosis, nasal, intramuscular, bleeding in the mouth and throat) F7 ranges from 20 to 40, frequency - every 12-24 hours, during the day;
- with more common bleeding (intramuscular, hematomas etc.) F7 - from 30 to 60, the drug is administered every 12-24 hours, 3-4 days;
- with life-threatening bleeding (on the neck, without a specific source, craniocerebral, with injuries with blunt objects) F7 - from 60 to 100, multiplicity - every 8 or 24 hours, until the threat to life disappears.
When removing teeth and other minor surgical interventions F7 from 30 to 60, the drug is administered once a day, until a blood clot forms.
For large operations F7 equals 80 or 100, the medicine is administered 8-24 hours before healing, then another week to maintain activity F7 40-60%.
During treatment, it is recommended to periodically find out the level of factors in blood plasma, do coagulogram.
In severe forms of the disease, it is sometimes recommended to enter 20-40 MEper kg of patient weight, especially at a young age.
Instructions for preparing a solution for intravenous administration
1. Heat to room temperature lyophilisate and the solution, without opening them and preventing liquid from entering the inside and the cork. If a water bath is used for heating, then the water temperature should be no more than 37 degrees.
2. Unscrew the protective caps of the bottles. Wipe the rubber plugs with one of the disinfectant wipes included in the kit.
3. Remove the double-ended needle. Insert its short end into the cork of the solvent bottle, then insert the long end into the lyophilisate.
4. Separate the solvent bottle together with the needle from the second (lyophilisate) Wait until the drug is completely dissolved, you can slightly shake the bottle.
5. The resulting preparation should be transparent, uniform, slightly opalescent.
I / O introduction Vilate
Before the procedure and during it is recommended to control heart rate (pulse). If the pulse is greatly increased, the process must be paused or stopped.
1. Pierce the solution plug with a filter needle.
2. Insert the second end of the filter needle into the tip of the disposable syringe.
3. Turn the bottle over and inject the medicine into the syringe.
4. Disinfect at the injection site.
5. Remove the filter needle from the syringe. Attach a butterfly needle to a disposable syringe.
6. The optimal rate of administration of the drug into the vein is 2-3 milliliters per minute.
The medicine remaining after the procedure must be disposed of.
There are no reported cases of drug overdose.
The drug does not interact with other means.
It is not recommended to mix the medicine in one syringe with other drugs or to use one infusion set twice.
Terms of sale
Need a recipe.
Keep away from children in a dark, cool place (2 to 8 degrees). Do not allow crystallization at temperatures below zero.
In order to avoid the occurrence of severe allergic reactions, you need to accurately calculate the dosage and monitor the patient's condition during infusion.
It is necessary to explain to the patient which adverse reactions may occur, which should be feared, and immediately inform the doctor.
If during treatment Vilate shock, standard measures should be applied to remove the patient from this condition.
The most dangerous complications during therapy with the drug - education blood clots and inhibitory antibodies.
Upon receipt of drugs from human blood, all necessary studies and measures are taken to prevent the penetration of dangerous virusesdifferent antigens and antibodies into finished products. However, it is likely that envelope viruses (parlovirus B19) will survive. Viruses of this kind can cause serious diseases in pregnant women, people with immunodeficiencyat hemolytic anemia.
As a prophylaxis, it is recommended to vaccinate against hepatitis A and AT before taking medications prepared from human blood.
During treatment may develop antibodiesinhibitory to factor F7. This process should be monitored, it may be necessary to conduct Bethesda test.
For intravenous administration and preparation of the drug can only be used with the tools supplied with the medicine.
AnalogsMatches for ATX Level 4 code:NovoSevenThrombinTannin
Immunate, Bioclot A, Adveit, Octanate, Benefix, Recombinant, Novoseven, Beriate.
During pregnancy and lactation
The use of the drug during pregnancy and lactation is possible only after consultation with a specialist.
There are very few reviews about the drug. Of those that are, no negative was found.
The cost of Vilate is approximately 19-25 thousand rubles per set, depending on the dosage.