Buy Coagil VII lyophilisate 4.8 mg vial 1 pc. packaging
  • Buy Coagil VII lyophilisate 4.8 mg vial 1 pc. packaging

Eptacog alfa activated

Generium
707 Items
2019-09-19
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$5,268.31
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Clinical Pharmacology

The mechanism of action is the binding of coagulation factor VIIa to the released tissue factor in the damage zone. The resulting complex stimulates the transition of coagulation factors IX and X to the active form IXa and Xa. Then, the coagulation factor Xa triggers the initial processes of converting prothrombin (II) into thrombin. Thrombin, by converting fibrinogen to fibrin, ensures the formation of a hemostatic plug, and also contributes to the activation of platelets and coagulation factors V and VIII in the damaged area. In pharmacological doses, eptacog alpha [activated] directly without tissue factor translates coagulation factor X into active form Xa on the surface of activated platelets in the damaged area, which leads to the formation of large amounts of thrombin from prothrombin.

Thus, the pharmacodynamic effect of the recombinant coagulation factor VIIa consists in the enhanced local formation of the coagulation factor Xa with the subsequent acceleration of the synthesis in the cascade of the enzymatic reactions of the coagulation system of blood thrombin and fibrin.

The use of eptacog alpha [activated] cannot completely exclude the risk of systemic activation of blood coagulation in patients suffering from diseases predisposing to the development of DIC.

Indications

To stop bleeding and prevent their development during surgery and invasive procedures:

- in patients with hemophilia (hereditary or acquired) with a high inhibitor titer to coagulation factors VIII or IX;

- in patients with congenital coagulation factor VII deficiency;

- in patients with Glantsman's thrombastenia in the presence of antibodies to glycoproteins IIb-IIIa and refractoriness (present or past) to platelet transfusions.

Composition

  • eptakog alpha [activated] 4.8 mg (240 KED / 240 thousand IU);
  • sodium chloride 23.36 mg;
  • calcium chloride dihydrate 11.76 mg;
  • glycylglycine 10.56 mg;
  • Polysorbate 80 0.56 mg;
  • mannitol 240.0 mg.

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Eptacog alfa activated

Inhibitor hemophilia A or B or acquired hemophilia

With the development of bleeding, it is necessary to introduce Coagil-VII as early as possible. Dose picked individually. The drug is introduced into / into the bolus for 2-5 minutes. Typically, the initial dose is 90 mcg / kg. After the first injection, the drug can be repeated every 2-3 hours until hemostasis is achieved. If there are indications to continue treatment, the intervals between doses of the drug can be consistently increased to 4, 6, 8 or 12 hours for the entire period of treatment. The duration of treatment and the interval between doses of the drug are determined by the severity of the bleeding, as well as the nature of the invasive interventions or surgery.

Mild to moderate bleeding (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 the bleeding stops. Another dose is administered to maintain the effect. A single dose can be given at the rate of 270 mcg / kg body weight. The duration of outpatient treatment should not exceed 24 hours. Early administration of the drug allows you to effectively control the bleeding of mild to moderate joints, muscles, skin and mucous membranes.

Severe bleeding

The dose is 90 mcg / kg, the drug can be entered at the stage of transportation to the clinic. Further treatment regimen depends on the type and severity of the bleeding. The drug is administered every 2 hours until the bleeding stops. If there are indications to continue therapy, the intervals between injections can be extended to 3 hours within 1-2 days. Subsequently, the intervals between administrations of the drug can be increased to 4, 6, 8 or 12 hours for the entire period of treatment. Depending on the indications, the duration of treatment may be 2-3 weeks or more.

Invasive Intervention / Surgery

Immediately before the intervention or operation, a dose of 90 mcg / 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. For large surgeries, treatment continues for 6–7 days with 2–4 hours intervals between doses. When treatment is carried out over the next 2 weeks, the intervals between injections of the drug can be increased to 6-8 hours. The total duration of the drug can be 2-3 weeks.

Factor VII Deficiency

For stopping bleeding and preventing their development during surgical operations or invasive interventions, the recommended doses are 15-30 mcg / kg body weight. The drug is administered every 4-6 hours to achieve hemostasis.

Glantsman Thrombasthenia

The dose for monitoring bleeding and preventing bleeding during surgical operations or invasive interventions is 90 mcg (80-120 mcg) / kg of body weight. The drug is administered every 2 hours. To ensure stable hemostasis requires at least three doses. The main method of treating patients with Glantsman thrombasthenia without refractoriness is the use of platelet mass.

Rules of preparation of injection solution

1. To heat the vials with the drug Koagil-VII (lyophilized) and ampoules with water for injection to room temperature (but not above 37 ° C), for example, holding the bottle and ampoule in your hands.

2. Remove the protective cap from the bottle.

3. Process the rubber stopper of the bottle and the neck of the ampoule with an alcohol swab. Let them dry before use.

4. Open the syringe blister pack, bending the paper cover to the middle.

5.Open the needle blister pack, bending the paper cover to the middle.

6. Put a sterile needle on the syringe without removing it from the protective cap. You must ensure that the tip of the syringe does not come into contact with your hand or other surface. Delay the syringe with the needle until the next manipulation.

7. Open the ampoule with water for injection.

8. Remove the protective cap from the needle.

9. Draw in the syringe the following amount of water for injection: 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 on the syringe 1 cm3

10. Enter the required volume of water for injection through the same needle into the vial with the required dosage of the drug Koagil-VII, slowly pressing the piston rod. The syringe should be kept slightly tilted downwards. The stream of water should not fall directly on the lyophilisate, as this may cause foam formation.

11. Carefully rotate the vial until all the substance has dissolved. Do not shake the vial. Ensure that the powder is completely dissolved.

12. Holding the vial upside down (upside down), draw the solution from it into the syringe, slowly and smoothly pulling the plunger out. You must make sure that the entire contents of the vial is in a syringe.

13. Without changing the position of the piston, remove the needle from the syringe. Release the air from the syringe.

14.Open blister packaging with injection filter.

15. Put the injection filter on the syringe. Care should be taken to ensure that there is no contact between the arm or other surface with the parts of the injection filter into which the syringe and IV injection system is inserted.

16. Attach the syringe to the attached IV injection system by turning the injection filter clockwise until it stops. Vent the air from the syringe with the injection filter attached and the IV injection system. Introduce the solution IV the jet (bolus) for 2-5 minutes.

If more than one vial is required, then the solution in each vial should be prepared using the attached solvent (water, for injection), and then the solutions should be combined in a larger syringe (not supplied) and the preparation should be administered in the usual manner.

A solution of the drug Koagil-VII is recommended to be used immediately after preparation.

Adverse reactions

On the part of the blood 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.

Since the cardiovascular system: in some cases (mainly at increased risk) arterial thrombosis develops - cerebrovascular circulation disorders (cerebral infarction and brain ischemia), angina pectoris, myocardial infarction, intestinal infarction; venous thrombosis - thrombophlebitis, deep vein thrombosis and their complications, pulmonary thromboembolism.

On the part of the digestive system: rarely - nausea, vomiting, rarely - increased levels of ALT, alkaline phosphatase, 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. Individual cases of the appearance of antibodies to factor VII after eptacog alpha (activated) have been described in patients with factor VII deficiency have been described. These patients had previously been 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 crush wounds, widespread atherosclerosis, thrombotic complications, sepsis, recent surgery due to the potential risk of thrombotic complications or DIC.

Drug interactions

Concentrates of the prothrombin complex (activated or non-activated) and Coagil-VII should not be administered simultaneously.

Antifibrinolytic agents reduce intraoperative blood loss in patients with hemophilia, especially during orthopedic operations and operations on tissues with high fibrinolytic activity, for example, in the oral cavity. However, the possibility of the combined use of antifibrinolytics and the drug Koagil-VII has not been studied.

Pharmaceutical Interaction

Do not enter Koagil-VII in the same syringe with any other drugs.

Pregnancy and Lactation

The use of the drug Koagil-VII during pregnancy and lactation (breastfeeding) should be limited to strict indications.

Special instructions

Patients with an increased risk of developing DIC are subject to strict monitoring of the clinical condition and indicators of coagulogram.

When using the drug Koagil-VII at home, patients or persons caring for them should inform the attending physician or clinic about each use case. If the bleeding cannot be stopped, hospitalization is required. The duration of outpatient therapy should not exceed 24 hours.

In patients with a deficiency of coagulation factor VII, the prothrombin time and activity of coagulation factor VII should be monitored before and after administration of Coagil-VII. If the activity of coagulation factor VIIa does not reach the expected level or the bleeding continues, despite the use of the drug in the recommended doses, the formation of antibodies can be assumed. In this case, an antibody test should be performed.

Patients who are at risk of developing venous thrombosis due to concomitant diseases, history of thrombosis, postoperative immobilization, or vein catheterization need careful observation.

Before use, check the solution for transparency and presence of inclusions. In the presence of inclusions solution can not be used.

Overdosage

If the recommended dose is exceeded, the risk of arterial and / or venous thrombosis increases by 10–20 times. In this regard, careful dynamic monitoring of the clinical condition and coagulogram indices is necessary.

Studies and clinical trials of Eptacog alfa activated (Click to expand)

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