Composition, form of production and packaging
Lyophilizate for the preparation of a solution for intravenous administration as an amorphous white mass.
1 f.
Eptacog alpha (activated) 1.2 mg (60 cfu / 60 thousand ME)
Excipients: sodium chloride, calcium chloride dihydrate, glycylglycine, polysorbate, mannitol.
Solvent: water d / and (5 ml).
Glass vials (1) complete with a solvent (1 pc.), A syringe, a dilution needle, a catheter for peripheral veins, an injectable filter and napkins alcohol (2 pcs.) - packs of cardboard.
Lyophilizate for the preparation of a solution for intravenous administration in the form of amorphous white mass.
1 f.
eptactog alpha (activated) 2.4 mg (120 cfu / 120 thousand ME)
Excipients: sodium chloride, calcium chloride dihydrate, glycylglycine, polysorbate 80, mannitol.
Solvent: water d / and (5 ml).
Glass vials (1) complete with a solvent (1 pc.), A syringe, a dilution needle, a catheter for peripheral veins, an injectable filter and napkins alcohol (2 pcs.) - packs of cardboard.
Lyophilizate for the preparation of a solution for intravenous administration as an amorphous white mass.
1 f.
eptactog alpha (activated) 4.8 mg (240 cfu / 240 thousand ME)
Excipients: sodium chloride, calcium chloride dihydrate, glycylglycine, polysorbate 80, mannitol.
Solvent: water d / and (10 ml).
Glass vials (1) complete with a solvent (2 pcs.), A syringe, a dilution needle, a catheter for peripheral veins, a filter with injection and napkins alcohol (2 pcs.) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2011.
PHARMACHOLOGIC EFFECT
Recombinant clotting factor VIIa, obtained by genetic engineering from hamster kidney cells (BHK cells). The molecular weight is approximately 50,000 daltons.
The mechanism of action is to bind the clotting factor VIIa to the released tissue factor in the injury zone. The resulting complex stimulates the transition of coagulation factors IX and X into the active form IXa and Xa. The blood coagulation factor Xa then starts the initial processes of the transformation of prothrombin (II) into thrombin. Thrombin by converting fibrinogen to fibrin provides the formation of a hemostatic plug, and also promotes the activation of platelets and coagulation factors V and VIII in the area of ​​injury.
In pharmacological doses, eptacog alpha (activated) directly transfers the clotting factor X to the active form Xa on the surface of activated platelets in the injury zone without the involvement of the tissue factor, which leads to the formation of large amounts of thrombin from the prothrombin. Thus, the pharmacodynamic effect of the recombinant coagulation factor VIIa is the enhanced local formation of the coagulation factor Xa and subsequent acceleration of synthesis in the cascade of enzymatic reactions of the blood coagulation system of thrombin and fibrin.
With the use of eptactagogue alpha (activated), the risk of systemic activation of blood coagulation in patients suffering from diseases predisposing to the development of DIC syndrome can not be completely ruled out.
PHARMACOKINETICS
According to the literature, T 1/2 recombinant coagulation factor VIIa in adults is 2-2.5 hours, in children T 1/2 is shorter. The average clearance of recombinant coagulation factor VIIa is 31.8 ml / h / kg, the clearance in children is twice as high on average.
INDICATIONS
To stop bleeding and prevent their development during surgical interventions and invasive procedures:
- in patients with hemophilia (hereditary or acquired) with a high titer of the inhibitor to coagulation factors VIII or IX;
- in patients with congenital deficiency of the clotting factor VII;
- in patients with Glanzman thrombasthenia in the presence of antibodies to glycoproteins IIb-IIIa and refractoriness (in the present or in the past) to transfusions of platelet mass.
DOSING MODE
Inhibitory haemophilia A or B or acquired hemophilia
With the development of bleeding, it is necessary to introduce Coagil-VII as early as possible. The dose is selected individually. The drug is administered iv bolus for 2-5 minutes. Typically, the initial dose is 90 Ојg / kg. After the first injection, the drug can be repeated every 2-3 hours until reaching hemostasis. If there are indications for continuing treatment, the intervals between drug administration can be consistently increased to 4, 6, 8 or 12 hours for the entire treatment period. The duration of treatment and the interval between drug administration are determined by the severity of the bleeding, as well as by the nature of the invasive interventions or surgical operation.
Bleeding of mild to moderate severity (including outpatient treatment)
The initial dose is 90 mcg / kg. To ensure hemostasis, 1-3 doses of the drug are administered at 3-hour intervals until bleeding stops. To maintain the effect, another dose is administered. A single dose regimen is possible at a rate of 270 Ојg / kg of body weight. The duration of outpatient treatment should not exceed 24 hours. Early administration of the drug can effectively control bleeding of mild and moderate severity in the joints, muscles, skin and mucous membranes.
Heavy Bleeding
The dose is 90 Ојg / kg, the drug can be administered during the transport to the clinic. The further scheme of treatment depends on the type and severity of the bleeding. The drug is injected every 2 hours until the bleeding stops. If there are indications for the continuation of therapy, the intervals between the administrations can be increased to 3 hours for 1-2 days. In the future, the intervals between administration of the drug can be increased to 4, 6, 8 or 12 hours for the entire treatment period. Depending on the indications, the duration of treatment can be 2-3 weeks or more.
Invasive procedures / surgeries
Immediately before the intervention or operation, a dose of 90 Ојg / kg is administered. The second dose is administered after 2 hours, and then the drug is administered at a 2-3-hour interval during the first 24-48 hours. In large operations, treatment lasts 6-7 days with 2-4 hour intervals between doses. During treatment for the next 2 weeks, the intervals between drug administration can be increased to 6-8 hours. The total duration of the drug can be 2-3 weeks.
Factor VII deficiency
To stop bleeding and prevent their development during surgical operations or invasive interventions, recommended doses are 15-30 Ојg / kg of body weight. The drug is injected every 4-6 hours until reaching hemostasis.
Glanzmann's thrombia
The dose for monitoring bleeding and preventing bleeding during surgical operations or invasive interventions is 90 Ојg (80-120 Ојg) / kg body weight. The drug is administered every 2 hours. To ensure persistent hemostasis, at least three doses are required. The main method of treatment of patients with thrombastenia Glanzmann without refractoriness is the use of platelet mass.
Rules for the preparation of injection solution
1. Heat the vials with the preparation Coagil-VII (lyophilizate) and ampoules with water for injection to room temperature (but not above 37 В° C), for example, holding the vial and ampoule in the hands.
2. Remove the protective cap from the bottle.
3. To work out a rubber stopper of a vial or flask and a neck of an ampoule alcohol sponges. Allow them to dry before use.
4.Open the blister pack of the syringe by bending the paper coating to the middle.
5.Open the blister pack of the needle, bending the paper cover to the middle.
6. Place the sterile needle on the syringe without removing it from the protective cap. It must be ensured that the tip of the syringe does not come into contact with the hand or other surface. Place the syringe with the needle until the next manipulation.
7.Close the ampoule with water for injection.
8. Remove the protective cap from the needle.
9. Select the following quantity of water for injection into the syringe: for a vial with a dosage of 1.2 mg - 2 ml; for a bottle with a dosage of 2.4 mg - 4 ml; for a bottle with a dosage of 4.8 mg - 8 ml.
1 ml = division by syringe 1 cm 3
10.Input the required volume of water for injection through the same needle into the bottle with the required dosage of Coaghil-VII preparation, slowly pressing the piston rod. The syringe should be kept slightly tilted downward. A jet of water should not fall directly onto the lyophilizate, because this can cause the formation of foam.
11. Carefully rotate the vial until all of the substance has dissolved. Do not shake the bottle. Make sure that the powder is completely dissolved.
12. Holding the bottle in an inverted state (upside down), draw a solution from it into the syringe, slowly and slowly pulling the piston. It should be ensured that the entire contents of the vial are typed in a syringe.
13. Without changing the position of the piston, remove the needle from the syringe. Release air from the syringe.
14.Open a blister pack with an injection filter.
15. Place the injection filter on the syringe. Care should be taken to avoid touching the hand or other surface with the parts of the injection filter into which a syringe and an IV infusion system are inserted.
16.Connect the syringe to the attached IV infusion system by turning the injection filter clockwise until it stops. Discharge air from the syringe with an attached injection filter and an IV infusion system. Inoculate the solution intravenously (bolus) for 2-5 minutes.
If more than one vial is required, the solution in each vial should be prepared with the supplied solvent (water, for injection), and then the solutions are combined in a larger syringe (not supplied) and the drug is administered in the usual manner.
A solution of the preparation Coagil-VII is recommended to be used immediately after preparation.
SIDE EFFECT
From the coagulation system: rarely - a decrease in the number of platelets and a decrease in the level of fibrinogen, an increase in the level of prothrombin, D-dimer.
From the side of the cardiovascular system: in some cases (mainly at an increased risk) arterial thrombosis develops - disorders of cerebrovascular circulation (cerebral infarction and cerebral ischemia), angina pectoris, myocardial infarction, intestinal infarction; venous thrombosis - thrombophlebitis, deep vein thrombosis and their complications, thromboembolism of the pulmonary artery.
On the part of the digestive system: rarely - nausea, vomiting, rarely - increased levels of ALT, APP, LDH.
Allergic reactions: rarely - skin rash, itching, redness of the skin.
Other: rarely - chills, fever, pain (including at the injection site), headache, weakness, increased sweating. Separate cases of the appearance of antibodies to factor VII after the use of eptactagogue alpha (activated) in patients with factor VII deficiency are described. These patients were previously transfused with human plasma and / or plasma factor VII.
CONTRAINDICATIONS
- hypersensitivity to proteins of mice, hamsters or cows;
- Hypersensitivity to the active component of the drug and excipients.
It should be used with caution in case of crushed wounds, widespread atherosclerosis, thrombotic complications, sepsis, recent surgical operations due to the potential risk of thrombotic complications or DIC.
PREGNANCY AND LACTATION
The use of Coagil-VII during pregnancy and lactation (breastfeeding) should be limited to strict indications.
SPECIAL INSTRUCTIONS
Patients with an increased risk of developing DIC syndrome are subject to strict monitoring of the clinical condition and coagulogram indices.
When using Coagil-VII at home, patients or caregivers should inform the attending physician or the clinic of each use. If bleeding can not be stopped, hospitalization is mandatory. The duration of outpatient therapy should not exceed 24 hours.
In patients with a deficiency of the blood clotting factor VII, prothrombin time and the activity of the blood coagulation factor VII should be monitored before and after administration of the Coagil-VII preparation. If the activity of the blood coagulation factor VIIa does not reach the expected level or the bleeding continues, despite the use of the drug in the recommended doses, it is possible to assume the formation of antibodies. In this case, an antibody test should be performed.
Patients who have a risk of developing venous thrombosis due to concomitant diseases, history of thrombosis, immobilization in the postoperative period, or catheterization of the veins need careful monitoring.
Before use, check the solution for clarity and presence of inclusions. If there are inclusions, the solution can not be used.
OVERDOSE
If the recommended dose is exceeded, the risk of developing arterial and / or venous thrombosis increases 10-20 times. In this regard, careful dynamic monitoring of the clinical status and coagulogram indices is necessary.
DRUG INTERACTION
Do not concomitantly administer prothrombin complex concentrates (activated or non-activated) and Coagil-VII.
Antifibrinolytic drugs reduce intraoperative blood loss in patients with hemophilia, especially in orthopedic operations and operations on tissues with high fibrinolytic activity, for example, in the oral cavity. However, the possibility of combined use of antifibrinolytic drugs and Coagil-VII preparation has not been studied.
Pharmaceutical interaction
Do not inject Coagil VII in one syringe with any other medicines.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
At a temperature of 2 В° to 8 В° C; Do not freeze. The drug should be stored out of the reach of children.
Shelf life of the drug -2 years, solvent - 4 years.
