ალიმენტური ტრაქტი და მეტაბოლიზმი
სისტემური გამოყენების ინფექციის საწინააღმდეგო
სისხლი და სისხლ-წარმომქმნელი ორგანოები
სამომავლოდ დაგეგმილი პროდუქტები
Blood and Blood Forming Organs
Vials. Each vial of Repretin contains alpha recombinant human erythropoietin
2000 IU, 4000 IU.
PHARMACODYNAMICS. Human erythropoietin (EPO) is purified glycoprotein,
stimulating erythropoiesis. Erythropoietin stimulates proliferation and
differentiation erythroid cells to normocytes. The action of erythropoietin
takes place at early stages of erythropoiesis, on the level of burst-forming
erythroid unit, colony-forming erythroid unit, further on the level of
proerythroblast, erythroblast and reticulocyte. The action of erythropoietin
takes place at early stages of erythropoiesis. Erythropoietin administration
allows normalization of hemoglobin and hematocrit level and elimination of
symptoms, related to anemia. Recombinant erythropoietin doesn't differ from
natural glycoprotein hormone, human erythropoietin, both by biological activity
and immunologically. PHARMACOKINETICS. The half-life period is 5-6 hours during
- anemia in patients with uremic phase of chronic renal insufficiency (CRI),
receiving therapy with chronic hemodialysis (CH) and constant outpatient
peritoneal hemodialysis (COPH);
- anemia, secondary to chemo- and radiotherapy of neoplasms;
- anemia during HIV-infection;
- EPO-dependant anemia(non-myeloid neoplasms, rheumatoid arthritis and other);
- to decrease the volume of transfused blood during extensive surgical
procedures and acute blood losses.
DOSAGE AND ADMINISTRATION:
Anemia in patients with uremic phase of CRI.
The drug product is administered intravenously at dose 200 IU/kg/week to the
patients on hemodialysis after hemodialysis session. It is recommended to divide
weekly dose (200 IU/kg/week) to 3 administrations during a week after each
session of hemodialysis. The drug product is administered subcutaneously at a
dose 100 IU/kg 1 time per week. The drug product is administered subcutaneously
to the patients on COPH at dose 75 IU/kg 1 time per week. The course of
treatment is 8 weeks. The intravenous administration of Repretin allows to
achieve maximum blood concentration of the drug within the first hour with
decrease to basic level by the end of the first day of administration. The
subcutaneous administration of Repretin allows achieving maximum blood
concentration of the drug regardless of type of dialysis during 8-24 hours with
decrease to basic level by the end of the second day after administration.
Subcutaneous administration of Repretin is reasonable for the routine therapy of
patients on hemo- and peritoneal dialysis, as it requires smaller initial dose.
Anemia of patients with CRI
The initial dose of Repretin is 30-75 IU/kg 3 times per week. The correction
period lasts till the moment the optimal hemoglobin level (110-125 g/l) and
hematocrit (30-35 %) are achieved. These parameters should be controlled every
The next situations are possible: 1) Hematocrit increases from 0.5 to 2.0 % per
week. The dose is not changed to achieve optimal rates in such case. 2)
Decreased response to EPO - the hematocrit increase rate is less than 0.5 % per
week. It is necessary to raise single dose on 25 IU/kg. The maximum dose is 300
IU/kg three times per week. 3)Increased response to EPO - the hematocrit
increase rate is more than 2.0 % within 2 weeks. It is niccesary to reduce
single dose by 1.5 times.
4) Hematocrit is low and reduces. It is necessary to analyze the reasons for
resistance. The treatment efficacy depends on the correctly selected treatment
scheme. The previous dose of the correction period is decreased on 25-30 % and
maintained on such level, so that the hematocrit value will be within 30-35%,
and hemoglobin concentration was 110-125 g/l. The maintaining dose is 50-60 IU/kg
three times per week. Subcutaneous administration is recommended as the most
economical and safe for the therapy during maintaining period.
Anemia of patients after chemo- and radiotherapy of neoplasms.
The endogenous erythropoietin level identification is recommended before the
treatment initiation. The initial dose is 150 IU/kg at the EPO concentration
less than 200 IU/ml. The dose increase to 300 IU/ml after 8 weeks from the
treatment initiation is possible if there is no response.
During the preparation to extensive surgical procedures Repretin is used at dose
100-300 IU/kg every other day, 10 days before surgical procedure and 4 - 6 das
1 vial in a carton box together with enclosed leaflet.