In patients undergoing allogeneic omnadren kidney transplantation and received Zenapax in a dose of 1 mg / kg every 14 days (a total of 5 infusions), while the last (fifth row) administration of the drug was an increase in the average maximum serum concentration . This is due to the humanisation of the protein, ie, combination, complementarity determining regions of the murine anti-Tac antibody framework and constant regions of the person.
On the systemic clearance of daclizumab affects body weight, age, gender, race and presence of proteinuria. Since it is established that the systemic clearance of the drug depends on the body weight, its dosing should be based “mg per kg of body weight.” The recommended dosing regimen provides drug exposure within 30% of the standard exposure in groups of patients with different demographic characteristics. In patients with renal graft Zenapax adjust the dose depending on the other factors identified (gender, proteinuria, race and age) is not required.
Pharmacokinetics in special groups children. Preliminary results of a pharmacokinetic study in 30 children indicate that daclizumab serum concentrations in children comparable omnadren to those in adult transplant patients and drug treated in the same dosing regimen. Tac subunit receptors to IL-2 were filled after the first administration of the drug at a dose of 1.0 mg / kg and remained in a saturation state at least the first three months after transplantation. Saturation of the Tac subunit of the receptor for IL-2 was the same as in adult patients with the same dosing regimen.
Prophylaxis of acute organ rejection in patients undergoing kidney transplantation. The drug is omnadren applied as part of immunosuppressive therapy with cyclosporin and corticosteroids.
The recommended dose of Zenapax is 1 mg / kg. Zenapax solution volume containing the desired dose is adjusted to 50 mL with sterile 0.9% sodium chloride solution and administered intravenously over 15 minutes. The drug can be administered into omnadren a peripheral or central vein.
The first administration Zenapax should be administered 24 hours before transplantation. The second and each subsequent dose administered at intervals of 14 days in total – 5 doses. The time of administration of subsequent doses should not deviate from the scheduled more than one day in one way or another.
Specific guidance on dosing dose adjustment in patients with severe renal impairment is not required. Data on dosing in patients with severe liver disease is not present. The preliminary results of safety studies and pharmacokinetics in children indicate that efficacy and good tolerability of Zenapax in children when administered in the prescribed mode dosing. Experience with Zenapax in patients with middle and old age (over 65 years) is limited due to the small number of transplants performed in patients in this age group.
Instructions on the treatment of drug Zenapax is not intended to be administered undiluted. Before intravenous injection should be diluted in 50 ml sterile 0.9% sodium chloride solution. Mixing solutions, can not shake the vial to avoid foaming; to dissolve it should be carefully flip. Measures should be taken to ensure the sterility of the prepared diluted solution, because the product contains no antimicrobial preservatives or bacteriostatics. Zenapax prepared for the on / in the introduction, is a colorless solution in single-use vials, the unused balance of the preparation should be discarded. Before the introduction of parenteral drug products should be inspected for the presence of mechanical impurities and discoloration. After preparation of the infusion solution it is necessary to enter intravenously no later than 4 hours. If the solution should be stored longer, it should be stored in a refrigerator at 2-8 on C, but not more than 24 hours. Add to the cooked solution Zenapax other drugs or introducing them simultaneously through the same infusion system is impossible.
Zenapax has no obvious toxicity. Toxicity profile other immunosuppressants (cyclosporin and corticosteroids, including connecting azathioprine or mycophenolate mofetil) while applying Zenapax such as while placebo assignment.
Safety Data Zenapax compared to placebo and in patients receiving cyclosporine and corticosteroids are given below.
Adverse events occurred in 95% of patients in the placebo group and 96% of patients in the group treated with Zenapax. Adverse events caused the elimination of studies in 8.5% of patients in the placebo group and 8.6% of patients in groups Zenapax.
Severe adverse events were reported in 44% of patients in the placebo group and 40% of patients in the Zenapax group.
Death in the first 6 months after transplantation occurred in 3.41% of patients receiving placebo and 0.6% of patients treated with Zenapax. Mortality after 12 months was 4.4% in the placebo group and 1.5% in the Zenapax group.
The most common adverse events were disorders of the gastrointestinal tract, which are at the same frequency were observed in the group Zenapax (67%) and placebo ( . 68%)
The frequency and types of adverse events in the placebo group and Zenapax were the same.
The following are the events, notes in the treatment of Zenapax in ≥ 5% of patients. Gastrointestinal: constipation, nausea, diarrhea, vomiting, abdominal pain, dyspepsia, . bloating, epigastric pain Central and peripheral nervous system: tremor, headache, dizziness, and insomnia. urinary tract: oliguria, dysuria, renal tubular necrosis. body as a whole : chest pain, fever, fatigue, edema. cardio- Cardiovascular system: an increase and decrease in blood pressure, tachycardia, bleeding, thrombosis. The bodies of breath shortness of breath, pulmonary edema, cough. Skin and appendages: poor wound healing, acne.Musculoskeletal system: bone pain and muscle pain. hematopoiesis and lymphatic system: lymphocele. Adverse events that occurred in 2-5% of patients treated with Zenapax. Gastrointestinal: flatulence, gastritis, hemorrhoids. metabolic and Nutritional: fluid retention, diabetes, dehydration. urinary tract: renal damage, hydronephrosis, bleeding from the urinary tract, renal failure, urinary retention. body as a whole : fever, general weakness, anaphylactoid reactions. Central and peripheral nervous system: cramps in the legs, tingling, depression, anxiety. respiratory: atelectasis, congestion in the lungs, pharyngitis, rhinitis, hypoxia, wheezing, pleural effusion. Skin and appendages: pruritus, hirsutism, rash, sweating; . The reaction at the injection site Musculoskeletal system: pain in the joints. Special Senses: blurred vision. Malignant neoplasms: a year frequency of malignancies in the placebo group was 2.7% in the Zenapax group – 1.5%. Inclusion of Zenapax in the scheme of therapy did not increase the number of post-transplant lymphomas, whose frequency was less than 1% in the placebo group and in the group of Zenapax. Hyperglycemia: abnormalities in general and biochemical blood test with placebo and Zenapax met with the same frequency, with the exception of level fasting plasma glucose (measured in a small number of patients). Increase in blood glucose was observed in 16% (10 of 64) of patients on placebo and 32% (28 of 88) to Zenapax. Most cases of hyperglycemia occurred either on the first day after the transplantation, when patients were receiving high doses of corticosteroids or in patients with pre-existing diabetes mellitus. Infectious diseases: overall incidence of infections including viral, fungal, bacteraemia and septicemia and pneumonia, Zenapax was using no more than a placebo.Types infections Zenapax groups and placebo were similar. Cytomegalovirus infection occurred in 16% of patients receiving placebo and 13% of patients treated with Zenapax. One exception was purulent-inflammatory diseases of the subcutaneous adipose tissue and wound infections, which occurred in 4.1% of patients in the placebo group and 8.4% of patients in the Zenapax group. At 1 year post-transplant infectious diseases killed 7 patients receiving placebo, and only 1 patient who received Zenapax. Children. The most common adverse events were hypertension (53%), post-operative pain (45%), diarrhea (43%) and vomiting (32%). The frequency of hypertension and dehydration was higher in children than in adults.
The maximum tolerated dose in patients has not been determined; the appointment was not possible to reach a dose of Zenapax animals. After bone marrow transplantation, drug was administered at a dose of 1.5 mg / kg, without any adverse events. In toxicological studies with a one-time administration of the drug to mice at a dose of 125 mg / kg no symptoms are observed toxicity.
In the toxicological studies with repeated intravenous administration of Zenapax in a dose of 1.5, 5.0 and 15 mg / kg per day for 28 days the monkeys Cynomolgus no effects toxicity observed.
In clinical studies in conjunction with Zenapax was administered the following drugs: cyclosporine, mycophenolate mofetil, gancyclovir, acyclovir, tacrolimus, azathioprine, antithymocyte immune globulin, muromonab-CD3 (OKT3), and corticosteroids. Any interactions while not mentioned.
Zenapax is a protein with immunosuppressive properties, should be administered only under qualified medical facility. Patients should be informed of the potential benefits of treatment and the degree of risk associated with the appointment of immunosuppressive drugs.
Severe hypersensitivity reactions after administration of Zenapax is rare, however, with the introduction of the drug at the ready should have everything necessary for their relief.
Patients receiving immunosuppressants after organ transplantation are at increased risk lymphoproliferative diseases and opportunistic infections. While Zenapax is an immunosuppressive agent, to date increase in the frequency of lymphoproliferative disease or opportunistic infections in its application were observed.
Caution should be exercised in the appointment of immunosuppressive drugs elderly patients.
Experience re-appointment or subsequent courses of therapy post-transplant patients with no Zenapax.
Pregnancy and lactation
Studies in animal reproduction with Zenapax were not carried out. Can Zenapax have a damaging effect on the fetus in the appointment of his pregnant woman or affect reproductive function is unknown.Since IgG can pass through the placental barrier, it is necessary to compare individual risk associated with Zenapax appointment of women of childbearing age, with potential benefits from the use of this drug. Women of childbearing potential must use contraceptive measures during treatment Zenapax, and for 4 months after the last injection.
Having got there Zenapax in breast milk is unknown. Because breast milk excreted many drugs, and because of the possible adverse reactions decision to discontinue breast-feeding or discontinue therapy Zenapax should be made taking into account the importance of the drug to the mother.
Release form and packing
In 5 ml of the product in the bottle. 1 or 3 bottles with automatic disconnection on the application is placed in a cardboard box
3 years. Do not use beyond the expiration date printed on the package.
In the dark place at a temperature of 2-8 on the S. Do not freeze.
The prepared dilute solution is stable for 24 hours at 2-8 on C or for 4 hours at room temperature. After preparation of the infusion solution it is necessary to enter intravenously no later than 4 hours. If the solution has to be stored longer, it should be placed in the refrigerator (at 2-8 on the C), but not more than 24 hours.
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