Recormon (epoetin beta) solution for injections 2000 IU/0.3 ml. syringe №6

Description

Recormon (epoetin beta) solution for injections 2000 IU/0.3 ml. syringe №6

Composition 

active substance: epoetin beta;

1 pre-filled syringe (0.3 ml of solution) contains epoetin beta 2000 IU (16.6 μg);

1 pre-filled syringe (0.6 ml of solution) contains epoetin beta 30,000 IU (250 mcg);

excipients: urea; sodium chloride; polysorbate 20; sodium dihydrogen phosphate, dihydrate; sodium hydrogen phosphate, dodecahydrate; calcium chloride, dihydrate; glycine; L-leucine; L-isoleucine; L-threonine; L-glutamic acid; L-phenylalanine; water for injections.

Medicinal form

Solution for injection.

Main physical and chemical properties: colorless, from transparent to slightly opalescent solution.

Pharmacotherapeutic group

Antianemic drugs.
ATX code B03X A01.

Pharmacological properties

The specified antianemic drug of glycoprotein origin, stimulating mitosis, contributing to the build-up of erythrocyte mass.

The substance is obtained by recombinant method, its constituents are identical to human erythropoietin.
Due to the use of high technologies, it has a high degree of purification.
Provides an increase in the number of blood elements (erythrocytes, reticulocytes, hemoglobin).

It is not cytotoxic. Does not stimulate the tumor process.
During clinical trials, volunteers are excreted in 4 – 12 hours.

Indications:

• anemic processes of various origins;
• kidney failure (hemodialysis is used and not);
• cancer patients receiving chemotherapy;
• prematurity of newborns.

Contraindications:

• Allergic reactions to epoetin beta, its auxiliary components;
• Severe hypertension;
• If the patient has heart attacks, strokes, thrombosis, thromboembolic events.

The medicine does not interfere with driving.

Application during pregnancy and lactation

Animal testing has shown no effect on the fetus. However, it is recommended to prescribe Recormon when there is a direct threat to the mother’s life.

Method of administration and dosage

Injected under the skin or intravenously. Intravenous administration involves the introduction of 2 minutes. and more. For hemodialysis patients, an arteriovenous shunt is used at the end of the process. In the absence of dialysis, subcutaneous administration is preferred.

The main task is to increase the hematocrit to 30 – 35% or not to resort to blood transfusion.
The therapy is two-stage.

• Stage 1 – correction. Both single and weekly dosages, as well as the route of administration, depend on the disease, hematocrit and hemoglobin levels.
• Stage 2 – supportive treatment. It is necessary to maintain a hematocrit of no more than 35%. To do this, the dosage is divided by 2 compared to the previous one. During subsequent treatment, it is changed taking into account the characteristics of the patient.

Pharmacotherapy with Recormon is long-term, but it can be stopped at any time.
In children, use the dosages that are recommended.

Prematurity babies receive injection treatment for 6 weeks. from 3 days after delivery.
In cancer processes, the medicine is injected under the skin 3 or 7 times a week. Start with a weekly dosage of 450 IU / kg. With a small increase in hemoglobin after 28 days, the dosage should be doubled. If it is not possible to achieve an increase in hemoglobin, the injections are stopped.

In some forms of leukemia, the drug is recommended to be administered for another 28 days after the termination of the use of chemotherapy drugs. With an excessive increase in hemoglobin, pharmacotherapy is temporarily interrupted until its concentration reaches ≤ 130 g / l.

With transfusions, the dosage of Recormon is determined on an individual basis.

Overdose

Practice shows that even high dosages of Recormon do not lead to overdose. It should be understood that these can be hypertension and the growth of erythrocytes.

Side effects

The most frequent are bouts of hypertension, patients are chilly, they complain of headache, aching bones. After a while, these phenomena disappear.
Less commonly, signs of allergy at the injection site.