Chemically synthesized a new class of continuous erythropoietin receptor activator action. Testosterone propionate epoetin beta kovapentnym conjugate is a protein produced by recombinant DNA and linear methoxypolyethylene glycol (PEG). Beta-methoxy zpoetin erythropoietin differs from the presence of an amide bond between the N-terminal amino group or ε-amino group of lysine, preferably Lys 52 and Lys 45 , and metoksipolietilenglikolbutanovoy acid. Molecular weight metoksipolietilen glycol-epoetin beta is about 60 kDa, including a 30 kDa molecular weight PEG. Mircera possesses distinct from erythropoietin activity at the receptor level and is characterized by a long association with the receptor and faster dissociation from the receptor, a reduced specific activity in vitro and higher activity in vivo, as well as an increased half-life that allows you to enter MIRCERA 1 time per month. mechanism of action MIRCERA stimulates erythropoiesis in the interaction with the erythropoietin receptor on the cells of the bone marrow progenitors. Clinical efficacy in 97.5% of patients with chronic kidney disease not on dialysis at MIRCERA therapy marked correction of anemia. In 93.3% of patients with chronic kidney disease who are on dialysis, treatment with MIRCERA marked correction of anemia. In patients undergoing dialysis, for a transfer from the treatment of darbepoetin alfa or epoetin at Mircera therapy target is maintained stable hemoglobin levels (Hb). Pharmacokinetics The half-life (the T ½ ) after the on / in the Mircera is 15-20 times longer than when administered recombinant human erythropoietin. clearance and volume of distribution of methoxy polyethylene glycol-epoetin beta are independent of dose. Long-term appointment does not affect the clearance, volume of distribution and bioavailability of methoxy-epoetinabeta. The introduction of methoxy polyethylene glycol-epoetin beta 1 every 4 weeks does not lead to significant accumulation of the drug, the accumulation ratio is 1.03 when the introduction of 1 every 4 weeks and 1 1.12- when administered once every 2 weeks. There were no differences in the pharmacokinetics of the drug in patients receiving and not receiving dialysis. Haemodialysis does not have vliyaniet on the pharmacokinetics of methoxy polyethylene glycol-epoetin beta. Gender, race, elderly: does not require an initial dose of methoxypoly correction -etilenglikol-epoetin beta.
anemia in chronic renal failure (classified NKF K / DOQI -with chronic kidney disease).
: Hypersensitivity to methoxy polyethylene glycol-epoetin beta or to any other component of the product. Uncontrolled hypertension. Children under 18 years of age (safety and efficacy not established).Precautions Pregnancy, lactation, hemoglobin disorders, liver failure, epilepsy, thrombocytosis (the number platelet 500 × 109 / l), as the safety and efficacy data for groups of CERA insufficiently studied.
Pregnancy and lactation
The safety and efficacy for these groups are not well understood. During pregnancy and lactation should be used only if the expected benefit to the mother outweighs the potential risk to the fetus or child.
In animal testosterone propionatehas no direct or indirect harmful effects with respect to pregnancy, embryonic / fetal development, birth or postnatal development. It is not known whether the output methoxy polyethylene glycol-epoetin beta in breast milk in humans. In animal studies demonstrated that methoxy polyethylene glycol-Gly epoeti N beta is excreted in breast milk.
Dosing and Administration
Considering a longer half-life, should be administered less frequently than other stimulants of erythropoiesis.
Treatment with testosterone propionatemust be started only under the supervision of a specialist.
The right-hander storage solution in outpatient and inpatient settings Mircera solution is sterile and contains no preservatives. Only use should be clear, colorless or slightly yellowish solution containing no vidimyh.primesey. Before the introduction of the solution was brought to room temperature, if the drug was stored in a refrigerator. Injection tube may be stored at room temperature for 1 month (not above 30 ° C) and should be used within the month. The vial may be stored for 7 days at room temperature (no higher than 25 ° C) and should be used in Techa-set of 7 days.
Unused solution should be discarded. Each vial or syringe-tube can be used only once. Do not shake. Dosing drug can be administered as a subcutaneous (s / c) and intravenous (i / v). The drug should be administered s / c in the shoulder area, the front of the thigh or abdominal wall. Hb content should monitor 1 biweekly until it is stabilized, and periodically after stabilization. The standard dosing regimen of patients who are not receiving erythropoiesis stimulator is currently recommended starting dose of 0.6 mcg / kg / in, or n / a 1 time in 2 weeks, the target hemoglobin> 110 g / l (6.83 mmol / l).
The dose of MIRCERA can be increased by 25-50% from the previous month if after raising Hb is less South / l (0.621 mmol / l). Further increase of a dose of about 25-50% can be carried out at intervals of 1 month in the time to reach the target content of individual Hb.
Dose CERA reduced by 25-50% from the previous month later if Hb increase of more than 20 g / l (1.24 mmol / l). If exceeding 130 g Hb / l (8.07 mmol / l), the treatment must be interrupted to reduce less than 130 g Hb / l (8.07 mmol / l) and then resume, at 50% of the previous one. When the target of 120 g Hb / l dose is changed to 25%. After discontinuation of therapy Hb is reduced by about 3.5 g / l (0.22 mmol / l) per week.
Correction of the dose is carried out not more than 1 time per month.
Patients receiving erythropoiesis stimulator currently Patients receiving other stimulator of erythropoiesis, can be translated into therapy . MIRCERA with administration mode 1 time per month or one time in 2 weeks n / a or / in the initial dose: depends on the weekly dose previously administered the drug – darbepo-ethinyl alfa or epoetin (alfa and beta) (see name1 and 2. ). The first injection of MIRCERA is carried out in the next scheduled day testosterone propionate of injection formerly used darbepoetin alfa or epoetin (alfa and beta). anabole steroide kaufen deutschland legale steroide anabolika steroide