Cibor 2500 solution for injection 2500IU 0.2ml syringes, 10pcs

Composition

Solution for injection in ready-made syringes of 0.2 ml,2 syringes packed in a blister,1,5,15,20 or 50 blisters placed in a cardboard box.

1 ml of Cibor 2500 injection solution contains:

Bemiparin sodium (equivalent to antifactor-Xa) – 12500 IU;

Additional substances.

Pharmacological action

Cibor is an anticoagulant drug for parenteral use. The drug contains an active component-bemiparin sodium-low molecular weight heparin, which is obtained by depolymerization of sodium heparin, secreted from the mucous membrane of the pig intestine.

The average molecular weight of bemiparin is 3600 Da. The content of molecular chains with a molar mass of less than 2000 Da is less than 35%, with a molar mass of 2000-6000 Da-50-75%, with a molar mass of more than 6000 Da-less than 15%. Bemiparin sodium has an anti-Xa-factor activity of about 80-120 IU of anti-factor-Xa per 1 mg of dry matter. Anti-IIa-factor activity – 5-20 IU of anti-factor-IIa per 1 mg of dry bemiparin sodium. The ratio of anti-Xa-factor and anti-IIa-factor activity is about 8.

Cibor has a pronounced anticoagulant effect, and when used in therapeutic doses, it practically does not increase blood clotting time. When administered subcutaneously, the bioavailability is 96%. Maximum activity is observed 2-4 hours after the injection. When therapeutic doses are administered, anti-IIa-factor activity is practically not manifested.

The half-life of a dose of 2500 to 12500 IU is 5-6 hours. To achieve a therapeutic effect, it is enough to administer the drug 1 time a day.

Indications

The drug Cibor is intended for the prevention of blood clotting in the extracorporeal circulation system during a hemodialysis session.

In addition, the drug Cibor 2500 is used to prevent thromboembolism during general surgical procedures. The drug Cibor 3500 is also used for the prevention of thromboembolism during surgical interventions in orthopedic practice.

Use during pregnancy and lactation

Cibor during pregnancy is prescribed after careful assessment of the risk / benefit ratio. In animal studies, the drug Cibor did not have a teratogenic effect, there are no data on the penetration of bemiparin through the hematoplacental barrier.

If it is necessary to use bemiparin during lactation, you should stop breastfeeding, after consulting your doctor first.

Contraindications

Cibor should not be prescribed to patients with hypersensitivity to bemiparin and heparin, as well as to patients with thrombocytopenia, immunologically caused by heparin (including in the anamnesis or if such a condition is suspected).

The drug should not be prescribed to people suffering from disorders of the blood coagulation system with a risk of bleeding, severe disorders of the pancreas and liver, as well as people with active bleeding.

Bemiparin is not prescribed for acute bacterial endocarditis, chronic endocarditis, injuries or surgical interventions in the field of vision, hearing and central nervous system, patients with disseminated intravascular coagulation syndrome.

It is not recommended to use the drug for people with a high risk of bleeding, in particular for active peptic ulcer, cerebral vascular aneurysm, hemorrhagic stroke and brain neoplasms. Cibor is not used in pediatrics. With caution, bemiparin is prescribed to patients suffering from impaired liver and kidney function, thrombocytopenia, circulatory disorders of the iris and retina of the eye of vascular origin, uncontrolled arterial hypertension, urolithiasis, as well as persons with a history of ulcerative lesions of the gastric and duodenal mucosa.

Due to the increased risk of hyperkalemia, Cibor should be used with caution in patients with diabetes mellitus, metabolic acidosis, chronic renal failure, and elevated plasma potassium levels, as well as in patients receiving potassium-sparing diuretics (such patients should have their potassium levels determined before starting bemiparin therapy and monitored throughout the course of treatment).

Special care should be taken when performing lumbar puncture, epidural or spinal anesthesia in patients receiving bemiparin, due to the risk of developing a spinal or epidural hematoma, the consequences of which may be permanent paralysis. The interval between taking bemiparin and performing these manipulations is determined by the attending physician. If symptoms of an epidural or spinal hematoma appear, a diagnosis should be made immediately and appropriate therapy should be prescribed.

Side effects

It is possible to develop such undesirable effects when using the drug Cibor:

Liver moans: transient increase in the activity of liver enzymes.

From the hematopoietic system: thrombocytopenia of varying severity of type I or II. If type I thrombocytopenia develops, discontinuation of the drug is not required. If, with the development of type II thrombocytopenia (usually noted on days 5-21 of bemiparin therapy), the platelet count decreases by 30-50% (compared to the level before the start of therapy), bemiparin should be discontinued and alternative therapy should be prescribed.

Allergic reactions: urticaria, pruritus, anaphylactoid reactions. In isolated cases, the development of skin necrosis was noted, which was preceded by erythema and erythematous painful spots, with the development of such side effects, immediate withdrawal of bemiparin is required. Local reactions: ecchymosis, necrosis, pain and hematoma at the injection site.

Others: bleeding, including from the skin, wounds, digestive and genitourinary tracts, and mucous membranes. Osteoporosis.

Epidural and spinal hematoma during lumbar puncture, spinal or epidural anesthesia.

Interaction

There are no data on pharmacological interactions of bemiparin, possible interactions should be considered based on data on other low-molecular-weight heparins, since:

Bemiparin should not be used in combination with other drugs that have anticoagulant properties and can inhibit platelet aggregation, as well as with systemic glucocorticosteroids and dextran, as these combinations increase the risk of bleeding. If it is impossible to avoid the combined use of these drugs, then blood clotting and the patient’s condition should be carefully monitored.

Bemiparin should also be used with caution in combination with medications that contribute to the development of hyperkalemia.

Concomitant use of Cibor with intravenous nitroglycerin may reduce the effectiveness of bemiparin sodium.

It is forbidden to mix the solution with other medicines for parenteral use.

How to take, course of use and dosage

Cibor is intended for parenteral use. Subcutaneous injection of the solution into the posterolateral lumbar region or anterolateral abdominal region is allowed, alternating the left and right sides. The needle of the syringe should be placed perpendicular to the skin fold. It is forbidden to rub the injection site. Intravenous use of Cibor is prohibited, and it is also not recommended to administer other drugs intramuscularly during bemiparin therapy due to the risk of developing a hematoma. The dose of bemiparin is determined by the doctor.

In general surgical procedures, it is recommended to administer 2500 IU (1 syringe of Cibor 2500) 2 hours before the start of surgery, and it is also allowed to conduct the first use of the drug 6 hours after the operation. On the next day after the first use of the drug, they switch to the use of 2500 IU of bemiparin with an interval of 24 hours. As a preventive measure, it is recommended to use it during the period of risk of developing thromboembolism or until the patient’s motor activity is restored.

The minimum recommended preventive course lasts 7-10 days. For operations with a high risk of venous thromboembolism, orthopedic practice usually recommends the introduction of 3500 IU (1 syringe of Cibor 3500) 2 hours before the start of surgery, and it is also allowed to conduct the first injection of the drug 6 hours after the operation. Then proceed to the introduction of 3500 IU with an interval of 24 hours. It is recommended to continue therapy with the drug until the patient’s motor activity is restored.

Therapy with the drug should be continued for at least 7-10 days.

To prevent blood clotting in the system during repeated hemodialysis lasting no more than 4 hours, it is recommended to prescribe 2500-3500 IU of the drug (depending on the patient’s weight, with a body weight of more than 60 kg,3500 IU is administered, less than 60 kg – 2500 IU) in the form of a bolus injection into the arterial bed at the beginning of the hemodialysis session.

Overdose

When using excessive doses of the drug Cibor in patients, the development of bleeding was noted.

Treatment is prescribed depending on the severity of hemorrhage, as well as the risk of thrombosis. With minor bleeding, therapy is rarely required. For more serious hemorrhages, use of protamine sulfate is prescribed, which slightly reduces the anti-X-factor activity of the drug Cibor for 2 hours.

For intravenous use, the dose of protamine sulfate is calculated individually depending on the dose of bemiparin (1.4 mg of protamine sulfate per 100 IU of anti-factor-Xa).

Storage conditions

At a temperature not exceeding 30 °C (do not freeze)

Shelf life

2 years

Active ingredient

Bemiparin sodium

Conditions of release from pharmacies

By prescription

Dosage form

solution for injection

Indications

Thrombosis prevention, Thromboembolism prevention