Prophylaxis of transplant rejection of the kidney. Patients with kidney transplant is recommended reception 1.0 g twice a day (daily dose of 2 g). Although clinical studies have shown that a dose of 1.5 g twice a day (daily dose of 3 g) is also a safe and effective, its advantages in terms of performance in patients with no established after kidney transplantation. Patients treated with 2 g per day winstrol before and after, the safety profile was generally better than those treated with a daily dose of 3 g prevention of heart transplant rejection. The recommended dosing regime – by 1.5 g of 2 times a day (daily dose of 3 grams) . . Prevention of rejection of liver transplant recommended dosing regimen – at 1.5 g 2 times a day (daily dose of 3 g). Treatment of the first or refractory rejection of a kidney transplant. The recommended dosing regime – 1.5 g of 2 times a day (daily dose of 3 g). After transplantation of kidney, heart or liver first dose of CellCept should be taken as soon as possible.
If neutropenia (absolute neutrophil count <1300 per 1 ml of blood) is necessary to interrupt treatment with winstrol before and after or reduce the dose and carefully observe the patient.
In patients with severe chronic renal impairment (glomerular filtration rate less than 25 mL / min / 1.73 m 2 ) is the nearest post-transplant period or after treatment for acute or refractory rejection should avoid doses greater than 1 g, 2 times a day.
data on patients with severe renal insufficiency who underwent a heart transplant or a liver, no.
no dose adjustment for patients with a delay function kidney transplant is not required.
Patients who have had a kidney transplant and have a heavy defeat of the liver parenchyma , dosage adjustment is not required. Data on patients with severe hepatic parenchyma, suffered a heart transplant, are not available.
In patients with middle and old age (≥ 65 years) who underwent a kidney transplant, the recommended dose is 1 g, 2 times a day, and after a heart transplant or a liver – 1.5 g 2 times a day (see “Specific information Classification”.). Children: safety and efficacy in patients of childhood has not been established. Pharmacokinetic data obtained from children undergoing kidney transplantation, are very limited, and in children after heart or liver transplants – are absent.
Profile of side effects associated with the use of immunosuppressive drugs is often difficult to establish due to the presence of underlying disease and the concurrent use of many other drugs.
Data from clinical studies
major adverse reactions associated with the use in combination with cyclosporine and corticosteroids for the prevention of rejection in renal, cardiac or hepatic transplant, are diarrhea, leukopenia, sepsis and vomiting; There is also evidence of increased incidence of opportunistic infections.
The safety profile of MMF in the treatment of refractory renal rejection similar to that in the prevention of kidney rejection when using the drug at a dose of 3 g per day. Diarrhea and leukopenia, followed by anemia, nausea, vomiting, abdominal pain, sepsis were the predominant adverse reactions occur in patients on winstrol before and afterfrequently than in patients intravenously treated with corticosteroids. Malignancies.Patients who have undergone a kidney transplant, heart or liver observed for at least 1 year, lymphoproliferative disease or lymphoma occurred in 0.4 – 1% of patients treated with (in doses of 2 or 3 g per day) in combination with other immunosuppressants. Skin carcinoma (excluding melanoma) was observed in 1.6 – 4.2% of patients, malignancies of other types – at 0.7 – 2.1% of patients. Three-year safety data in patients after kidney transplantation or heart did not reveal any unexpected changes in the incidence of malignant neoplasms, compared with growth rates. After a liver transplant patients were followed for at least 1 year but less than 3 years. In the treatment of refractory renal rejection frequency of lymphomas with a median follow up of 42 months was 3.9%. Opportunistic infections. The risk of opportunistic infections increased in all post-transplant patients and increases with the degree of immunosuppression .
When assigning MMF (2 or 3 g per day) in combination with other immunosuppressive drugs in patients followed for one year after kidney transplantation (at a dose of 2 grams per day), the heart and the liver, the most frequent infections were candidiasis skin and mucous membranes, syndrome (13.5%) and infection caused by the herpes simplex virus. Patients elderly (≥ 65 years) in the treatment of as part of combination immunosuppressive therapy, the risk of certain infections (including tissue invasive forms of symptomatic infection), as well as possibly gastrointestinal haemorrhage and pulmonary edema is higher than in patients over young age.
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