Composition, form of production and packaging
Lyophilizate for the preparation of a solution for intravenous administration is white or slightly colored, in the form of a powder or a loose solid mass.
clotting factor VII (in the form of protein contained in plasma 50-200 mg / fl.) 600 IU
Excipients: sodium citrate dihydrate, sodium chloride, heparin.
Solvent: water d / u - 10 ml.
Vials (1) complete with solvent (fl.), Disposable syringe, disposable needle, transfer needle, filter needle, aerating needle and transfusion system - cardboard packs.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2010.
Factor VII is one of the vitamin-K-dependent factors of normal human plasma, a component of the external pathway of the blood coagulation system. It is the zymogen of serine protease factor VIla, which triggers the external pathway of the blood coagulation system. The introduction of the human factor VII concentrate increases the concentration of factor VII in plasma and provides a temporary correction of the defect of the clotting system in patients with factor VII deficiency.
With the / in the introduction of Factor VII, an increase in its concentration in the blood plasma of the patient is 60-100%; T 1/2 is an average of 3-5 hours.
Treatment and prevention of blood clotting disorders caused by hereditary or acquired deficiency of factor VII;
- Acute bleeding and prevention of bleeding during surgical interventions in patients with congenital deficiency of factor VII (hypo- or aproconvertinemia);
- Acute bleeding and prevention of bleeding during surgery with acquired factor VII deficiency due to taking oral anticoagulants;
- Vitamin K deficiency (for example, if there is a violation of its absorption in the gastrointestinal tract, with prolonged parenteral nutrition);
- hepatic insufficiency (for example, with hepatitis, liver cirrhosis, severe toxic liver damage).
The duration of replacement therapy and dose depend on the severity of factor VII deficiency, the location and extent of bleeding or hemorrhage, as well as the clinical condition of the patient. The administered dose of factor VII is calculated in international units (IU) according to existing WHO standards for preparations containing factor VII. The activity of factor VII in plasma can be calculated as a percentage of the norm and in international units.
One international unit of factor VII activity is equivalent to the activity of factor VII in 1 ml of normal human plasma.
The calculation of the dose required is based on an empirical observation that 1 International Factor VII (ME) per kilogram of body weight increases the activity of factor VII in the blood plasma by about 1.9% (0.019 IU / ml) relative to the normal level of activity.
The required dose is determined using the following formula:
Necessary dose (ME) = body weight (kg) x desired increase in Factor VII activity (IU / ml) x 53 * (unit divided by observed recovery (ml / kg)}
* (since 1: 0.019 = 52.6)
In determining the dose and frequency of administration of the drug in each case, the clinical effect should be considered.
Type of bleeding Therapeutically necessary activity of factor VII in plasma Duration of maintenance of the therapeutically necessary activity of factor VII in plasma
Small bleeding and minor surgical interventions. 10-20% Single dose (with slight bleeding) or until the wound is fully healed (with minor surgery).
Severe bleeding and extensive surgery 20-25% For 8-10 days or until the wound is fully healed.
When choosing the interval of administration, it should be taken into account that T 1/2 of factor VII is very short - about 3-5 hours.
If it is necessary to maintain a high level of factor VII in the plasma for a long time, the drug should be administered at an interval of 8-12 hours.
Correction of the dose for liver diseases is not required.
Method of administration
The preparation for intravenous administration of the factor VII lyophilizate should be prepared immediately prior to administration. Use only the supplied insertion kit. The solution should be clear or slightly opalescent. Do not use the solution if it is cloudy or there are mechanical inclusions in it. All used materials and unused solution must be disposed of in accordance with established rules.
Preparation of a solution of lyophilized concentrate
1. Closed vial with solvent to heat to room temperature (not above 37 В° C).
2. Remove the protective caps from the bottles with the concentrate of factor VII and the solvent, disinfect the rubber stoppers on both bottles.
3. Rotate and then remove the protective packaging from one end of the supplied needle. Pierce this end of the needle with a rubber stopper bottle with a solvent.
4. Carefully remove the protective packaging from the other end of the adapter needle, without touching the needle itself.
5. Turn the vial with solvent and pierce the rubber cap of the vial with a concentrate of factor VII with the free end of the needle-adapter. Due to the vacuum, the solvent will flow into the vial with a factor VII concentrate.
6. Disconnect the vials by removing the needle-adapter from the vial of Factor VII concentrate. For faster dissolution of the concentrate, the vial is gently rotated and shaken.
7. To deposit the foam after completely dissolving the concentrate, insert the supplied airway needle into the vial. Remove the airway needle after the foam settles.
1. Rotate and then remove the protective package from the filter needle and install it on a sterile disposable syringe. Draw the solution into the syringe.
2. Disconnect the needle filter from the syringe, insert a butterfly needle or disposable needle for injection and inject the solution iv slowly (at a rate of no more than 2 ml / min).
3. When administered at home, the patient should fold all used materials into the package from the drug and take it to a medical facility where it is observed for monitoring.
For IV injection, a disposable transfusion system with a filter should be used.
Rarely , allergic reactions (such as urticaria, nausea, vomiting, bronchospasm, lowering blood pressure) are observed, in some cases - severe anaphylaxis (including shock).
In rare cases, fever was noted. When treating with prothrombin complex factors, one of which is factor VII, thromboembolic complications are possible, especially in cases where high doses of the drug and / or patients having risk factors for thromboembolism are prescribed.
- a syndrome of disseminated intravascular coagulation (ICD) and / or hyperfibrinolysis until the causes underlying it are eliminated;
- history of heparin-induced thrombocytopenia;
- age up to 6 years;
- Hypersensitivity to the drug or to any of its components.
Due to the risk of developing thromboembolic complications, the drug with extreme caution should be used in patients with a history of coronary heart disease, myocardial infarction, liver disease, as well as in post-operative patients, newborns and people at high risk of thromboembolism or DIC. In these cases, it is necessary to correlate the possible benefits of using Factor VII with the risk of developing these complications.
PREGNANCY AND LACTATION
The safety of Factor VII in pregnancy was not supported by controlled clinical trials. Therefore, Factor VII can be administered during pregnancy and lactation only according to strict indications
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
With caution should prescribe the drug for liver disease.
APPLICATION FOR CHILDREN
Contraindicated in children younger than 6 years.
Since Factor VII is a protein preparation, allergic reactions are possible. Patients should be informed of early symptoms of allergy, such as urticaria (including generalized), chest tightness, wheezing, falling AD and anaphylaxis. When these symptoms appear, patients should immediately stop treatment and contact their doctor.
With the development of shock should act in accordance with the currently established rules for the treatment of shock.
Based on the experience of using the human plasma prothrombin complex, we can speak of an increased risk of thromboembolic complications and DIC syndrome in patients receiving human plasma factor VII.
Theoretically, factor VII substitution therapy can lead to the development of factor VII inhibitors in a patient. However, until now no such case has been described in clinical practice.
The amount of sodium in the maximum daily dose can exceed 200 mg, which should be taken into account when used in patients on a diet with a lower sodium content.
Factor VII is produced from human plasma. With the introduction of drugs made from human blood or plasma, the possibility of transmission of viruses can not be completely ruled out. This also applies to pathogens, the nature of which is currently unknown.
The risk of virus transmission is minimized as a result of a number of security measures, namely:
- selection of donors based on medical examination and screening of blood and plasma from each donor, as well as plasma pools for HBsAg and antibodies to HIV and hepatitis C viruses;
- testing of plasma pools for the presence of genomic material of hepatitis A, B and C viruses, HIV-1 and HIV-2, and parvovirus B19;
- use in the production process methods of inactivation / removal of viruses. Viruses-pathogens and / or virus models have been shown to be effective against hepatitis A, B and C viruses, HIV-1 and HIV-2.
However, the effectiveness of in vitro inactivation / removal methods may not be sufficient for some non-enveloped viruses, for example, parvovirus B19, and also for currently unknown viruses. Infection with parvovirus B19 can be dangerous for pregnant women (infection of the fetus), as well as for individuals with immunodeficiency or increased production of red blood cells (eg, hemolytic anemia).
Patients receiving human plasma factor VII are recommended to vaccinate against hepatitis A and B.
Currently, there is insufficient data to recommend the appointment of Factor VII to children under 6 years of age.
In the interests of the patient, it is recommended that, with each addition of Factor VII, the series and number of the administered preparation be monitored.
Impact on the ability to drive vehicles and manage mechanisms
There was no impact on the ability to drive and move vehicles.
When using large doses of preparations containing factor VII, there were cases of myocardial infarction, disseminated intravascular coagulation syndrome, venous thrombosis and pulmonary embolism. Therefore, in case of overdose in patients with risk factors for thromboembolic complications or disseminated intravascular coagulation syndrome, the likelihood of these complications increases.
INTERACTION WITH OTHER PREPARATIONS
No interactions of human plasma Factor VII with other drugs were noted.
Before the introduction of Factor VII should not be mixed with other drugs. When using a venous catheter, it is recommended to wash it with an isotonic saline solution before and after the introduction of Factor VII.
Influence on laboratory indicators:
In patients receiving large doses of Factor VII, the presence of heparin in the preparation should be taken into account when conducting coagulologic tests sensitive to heparin. If necessary, the action of heparin can be neutralized by adding protamine to the test sample.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored out of reach of children at a temperature of 2 В° to 8 В° C. Shelf life - 3 years.