Epobiocrin solution for injections 1000 IU №5 syringe

Description

Epobiocrin 1000 IU Composition
active substance: Epoetin alfa;

1 ml of solution contains recombinant human erythropoietin 1000 IU or 2000 IU, or 4000 IU, or 10000 IU;

Epobiocrin 1000 IU excipients: human albumin; sodium citrate; sodium chloride; citric acid monohydrate; water for injections.

Epobiocrin 1000 IU Dosage form
Injection.

Basic physical and chemical properties: transparent colorless solution.

Pharmacological group
Antianemic medicines. Erythropoietin.

ATX code B03X A01.

Pharmacological properties

Pharmacodynamics.

In terms of biological and immunological activity, recombinant human erythropoietin corresponds to human erythropoietin, a natural glycoprotein hormone that plays the role of a factor that stimulates mitosis and is a hormone that stimulates erythropoiesis, the process of erythrocyte formation from stem cell precursors. Normally, in a healthy person, erythropoietin is synthesized by the kidneys (90%) and Kupffer’s cells of the liver (10%). The level of its synthesis is determined by the level of oxygen saturation in the blood. Erythropoietin stimulates the proliferation and differentiation of erythroid cells into mature erythrocytes. Its action is carried out in the early stages of erythropoiesis at the level of cluster-forming units-erythrocytes and colony-forming units-erythrocytes, then at the level of proerythroblast, erythroblast and reticulocyte (the sensitivity of these cells to erythropoietin is proportional to their degree of maturity). Erythropoietin normalizes hemoglobin and hematocrit levels and relieves symptoms associated with anemia.

Pharmacokinetics.

Intravenous administration. With intravenous administration of the drug, the half-life in individuals with normal renal function is about 4 hours; in patients with impaired renal function – about 5 hours. The half-life in children is about 6 hours.

Subcutaneous administration. Plasma concentrations for subcutaneous administration are significantly lower than for intravenous administration. With subcutaneous administration, the concentration of the drug in the blood increases slowly and reaches a maximum 12-18 hours after administration. The maximum concentration in blood plasma with subcutaneous administration is lower than that with intravenous administration (by about 1/20 of the value).

There is no cumulative effect, that is, the measured serum erythropoietin concentrations remain the same regardless of whether the drug concentration is determined 24 hours after the first injection or 24 hours after the last.

Indications
Treatment of symptomatic anemia associated with chronic renal failure

treatment of anemia associated with chronic renal failure in children and adults on hemodialysis and adult patients on peritoneal dialysis;
treatment of severe anemia of renal origin, accompanied by clinical symptoms, in adult patients with renal failure who have not yet undergone hemodialysis.
Treating anemia and reducing the volume of necessary blood transfusions in adult patients who are receiving chemotherapy for a nonmyeloma tumor, malignant lymphoma or multiple myeloma and who have an increased risk of transfusion, assessed by the patient’s general condition (including cardiovascular status, existing anemia before chemotherapy).

Epobiocrin can be used within the pre-deposit program before major surgical interventions in patients with moderate manifestations of anemia (hemoglobin level 10-13 g / dL (6.2-8.1 mmol / L), absence of iron deficiency) to facilitate the collection of autologous blood and reduce the risk, associated with the use of allogeneic blood transfusions, if the expected need for blood for transfusion exceeds the amount that can be obtained by autologous collection without the use of epoetin alfa.

Contraindications
Hypersensitivity to the components of the drug.
Development of true erythrocyte aplasia due to treatment with epoetin alfa (see “Peculiarities of use”).
Uncontrolled hypertension.

Contraindication

Anxiety associated with the autologous blood sampling program for patients receiving epoetin alfa.
Severe coronary, peripheral arterial, carotid or cerebrovascular diseases, as well as recent myocardial infarction or stroke in patients undergoing elective orthopedic surgery but not participating in an autologous blood collection program. The impossibility of using adequate antithrombotic prophylaxis in surgical patients.