Recormon injections 2000ME 0,3 ml №6
Description for Recormon injections 2000ME 0,3 ml №6
Recormon (Recormon)
Release form, composition and packing
Valium for a solution for subcutaneous injection in a homogeneous powder or porous mass of white: the solvent - a colorless, transparent liquid; prepared solution - a colorless, transparent or slightly opalescent liquid.
1 Cartridge
epoetin beta 10 000 IU
- - 20 000 IU
Other ingredients: urea, sodium chloride, sodium hydrogen phosphate, sodium dihydrogen phosphate, calcium chloride, polysorbate 20, glycine, L-Leucine, L-isoleucine, L-threonine, L-glutamic acid, L-phenylalanine.
Solvent: benzyl alcohol, benzalkonium chloride, water, d / and (1 ml).
Solution for iv and sc administration colorless, transparent or slightly opalescent.
A syringe-tube
epoetin beta 1000 IU
- "- 2000 IU
Other ingredients: urea, sodium chloride, sodium hydrogen phosphate, sodium dihydrogen phosphate, calcium chloride, polysorbate 20, glycine, L-Leucine, L-isoleucine, L-threonine, L-glutamic acid, L-phenylalanine, water d / and.
Solution for iv and sc administration colorless, transparent or slightly opalescent.
A syringe-tube
epoetin beta 10 000 IU
- - 20 000 IU
Other ingredients: urea, sodium chloride, sodium hydrogen phosphate, sodium dihydrogen phosphate, calcium chloride, polysorbate 20, glycine, L-Leucine, L-isoleucine, L-threonine, L-glutamic acid, L-phenylalanine, water d / and.
Solution for iv and sc administration colorless, transparent or slightly opalescent.
A syringe-tube
epoetin beta 30,000 IU
Other ingredients: urea, sodium chloride, sodium hydrogen phosphate, sodium dihydrogen phosphate, calcium chloride, polysorbate 20, glycine, L-Leucine, L-isoleucine, L-threonine, L-glutamic acid, L-phenylalanine, water d / and.
Clinico-pharmacological group: stimulator of erythropoiesis.
Pharmacological action
Stimulant of hematopoiesis. Epoetin beta - glycoprotein consisting of 165 amino acids, which, as a mitogenic factor and differentiation hormone, promotes the formation of red blood cells from a partially deterministic progenitor cells of erythropoiesis.
Recombinant epoetin beta produced by genetic engineering, in its amino acid and carbohydrate composition is identical to the human erythropoietin.
Epoetin beta after iv and sc administration increases the number of red blood cells, reticulocytes and hemoglobin levels, as well as the rate of incorporation of iron (59Fe) in cells which specifically stimulates erythropoiesis, without affecting the leykopoez. Cytotoxic effect of epoetin beta on bone marrow cells or human skin were found.
Pharmacokinetics
Suction
Bioavailability of epoetin beta at s / c infusion 23-42%. When s / c infusion of the drug in patients with uraemia prolonged absorption provides a plateau drug concentration in serum. Tmax - 12-28 hours
Distribution
Vd is bcc or 2 times more than him.
Breeding
In patients with uremia and in healthy volunteers, T1 / 2 at / in the introduction of 12.4 hours T1 / 2 terminal phase in the s / c infusion than after iv injection, averaging 13-28 hours
Pharmacokinetics in special clinical situations
Pharmacokinetics of epoetin beta in patients with liver failure has not been studied.
Statement
symptomatic anemia in chronic kidney disease patients on dialysis;
symptomatic anemia of renal origin in patients not yet on dialysis;
treatment of symptomatic anemia in adults with solid tumors and hematological nemieloidnymi receiving chemotherapy;
to increase the volume of donor blood, intended for subsequent autotransfusion (c registered account the risk of thromboembolic events and only for patients with moderate anemia (Hb 100-130 g / L or 6.21-8.07 mmol / l), no iron deficiency), if a a sufficient number of preserved blood is not possible, and planned major elective surgery may require a large volume of blood (> 4 units for women or> 5 units for males);
prevention of anemia in premature newborns weighing 750-1500 g and 34 weeks of gestation.
Dosing regimen
Treatment of anemia in patients with chronic kidney disease
Injected sc or iv within 2 min. Patients on hemodialysis - through arteriovenous shunt at the end of dialysis. Patients not receiving dialysis, the drug is preferably administered sc, to avoid puncture of peripheral veins.
The goal of treatment - an indicator of hemoglobin (Hb) of 100-120 g / liter. Hb should not exceed 120 grams per liter. An increase in Hb by more than 20 g / L (1.3 mmol / L) for 4 weeks dose should be reduced. In patients with hypertension, cardiovascular and cerebrovascular diseases weekly increase in hemoglobin and its targets should be determined individually, depending on the clinical picture. Should conduct a careful observation of the patient in order to select the minimum dose sufficient to provide the maximum effect of the drug. Treatment Recormon carried out in 2 stages.
Stage of correction. N / a, the initial dose - 20 IU / kg 3 times a week. With insufficient increase in Hb (less than 2.5 g / week) dose may be increased every 4 weeks to 20 IU / kg 3 times a week. The total weekly dose of the drug can also be divided by daily injection.
In / in, the initial dose - 40 IU / kg 3 times a week. With insufficient increase of Hb in a month dose may be increased to 80 IU / kg 3 times a week. If necessary, further doses should be increased to 20 IU / kg 3 times a week, at monthly intervals.
Regardless of the mode of administration, the maximum dose should not exceed 720 IU / kg per week.
Supportive therapy. To maintain the target Hb (100-120 g / L) dose should first be reduced by a factor of 2 from the previous dose. Subsequently, the maintenance dose is selected individually, with an interval of 2 or 4 weeks. When s / c infusion weekly dose may be administered for 1 admission or divide by 3 or 7 injections per week. When stabilization against the introduction of 1 time per week you can go to the introduction of 1 every 2 weeks, in this case may need to increase the dose.
Treatment Recormon usually done for a long time. If necessary, it can be interrupted at any time.
Treatment of symptomatic anemia in patients with solid tumors and hematological nemieloidnymi receiving chemotherapy
The drug is administered sc, at an initial dose of 30,000 IU per week (450 ME / kg per week), single or separated by a weekly dose for 3 or 7 injections.
Recormon therapy is indicated for Hb ≤ 110 g / L (6.83 mg / dL). The index of Hb should not exceed 130 g / L (8.7 mmol / l).
An increase in Hb of 10 g / L (0.62 mg / dL) after 4 weeks - therapy should continue at the same dose.
An increase in Hb of less than 10 g / L (0.62 mg / dL) after 4 weeks - the dose should be doubled.
In the absence of increase of Hb of 10 g / L (0.62 mg / dL) after 8 weeks - treatment should be discontinued because response to therapy Recormon unlikely.
Treatment should continue for 4 weeks after chemotherapy.
The maximum dose should not exceed 60 000 ME per week.
Upon reaching the target Hb for the individual patient dose should be reduced by 25-50%.
To prevent the increase of Hb of more than 130 g / L may require further dose reduction.
With an increase in Hb by more than 20 g / L (1.3 mmol / l) per month, should reduce the dose Recormon by 25-50%.
Preparing patients for taking blood for subsequent autotransfusion
V / a (within 2 min) or n / a, 2 times per week for 4 weeks. In cases where the hematocrit in a patient (≥ 33%) allows for blood sampling, Recormon should enter at the end of the procedure.
Throughout the course of treatment hematocrit should not exceed 48%.
Dose is determined by the physician and surgeon-transfusion individually, depending on how much blood is taken from the patient and his erythrocyte reserve:
1. Blood volume, which will be taken from the patient, depending on the expected blood loss of available blood conservation techniques and general condition of the patient, it should be sufficient to avoid transfusion of blood from another donor.
2. Blood volume, which will be taken from the patient, expressed in units (1 unit is equivalent to 180 ml of red blood cells).
3. The possibility of donation depends mainly on the volume of blood in this patient and the initial hematocrit. Both measures determine the endogenous erythrocyte reserve, which is calculated as follows:
Endogenous erythrocyte reserve = blood volume [ml] x (hematocrit - 33): 100
Women: blood volume [ml] = 41 [ml / kg] x body weight [kg] + 1200 [ml]
Men: blood volume [ml] = 44 [ml / kg] x body weight [kg] + 1600 [ml] (with a body weight> 45 kg).
Recormon injections 2000ME 0,3 ml №6
$390.00