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Blood and Blood Forming Organs

Repretin (Injections)
(Epoetin Alfa)



CONTENT:
Vials. Each vial of Repretin contains alpha recombinant human erythropoietin 2000 IU, 4000 IU.
 
PHARMACOLOGICAL PROPERTIES:
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 intravenous administration.
 
THERAPEUTIC INDICATIONS:
- 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 week.
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.
Surgery.
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 after surgery.
 
PACKAGING:
1 vial in a carton box together with enclosed leaflet.
 
 
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