Hemodialysis reduces ganciclovir concentration in plasma after intravenous or oral administration at doses of 1.25-5.0 mg / kg to about 50%. When using an intermittent hemodialysis circuit indicators ganciclovir clearance ranging from 42 to 92 ml / min period The primobolan cycle of the drug during dialysis – 3.3-4.5 hours. With continuous dialysis clearance of ganciclovir was lower (4.0 – 29.6 mL / min), but prior to the next dose of the drug from the body was removed by a greater percentage of the dose. In intermittent hemodialysis, the fraction of ganciclovir removed in a single session of hemodialysis, is from 50% to 63%.
Children: newborns between the ages of 2 and 49 days after the intravenous dose of 4 mg / kg and 6 mg / kg Cmax average equaled 5.5 6 mg / 7.0 ml and 1.6 ug / ml, respectively. The mean volume of distribution at steady state (0.7 l / kg) and the systemic clearance (3.15 0.47 ml / min / kg after a dose of 4 mg / kg and 3.55 0.35 ml / min / kg after a dose of 6 mg / kg) were similar to those in adults patients with normal renal function.
Infants with normal kidney function, aged 9 months to 12 years after ganciclovir pharmacokinetic characteristics of single and multiple (from 12 hours apart) intravenous administration at a dose of 5 mg / kg were similar. At 1 and 14 days and amounted 7.1 19.4 24.1 14.6 mcg x h / ml, respectively, and the corresponding , 8.31 and 4.9 ug / ml (day 14). This range is comparable to the performance that is typical adult. The pharmacokinetic parameters in children of 9 months. 12 years corresponded to those of infants and adults. Patients elderly: Studies in patients over 65 years was carried out.
Prevention and treatment of life-threatening or sight symptomatic primobolan cycle infection in immunocompromised persons; prevention of symptomatic infection in patients after organ transplantation.
Hypersensitivity to Tsimevenu, valganciclovir or to any other component of the preparation.
Due to the similarity of the chemical structure and aciclovir and valaciclovir between these medications may be the reaction of cross-hypersensitivity.
The absolute neutrophil count less than 500 cells in 1 mm, or a platelet count less than 25,000 cells in 1 mm or the hemoglobin level is less than 8 g / dL.
Children under 12 years old.
Precautions – Renal Failure.
Pregnancy and lactation
During treatment with ganciclovir should be recommended for women of childbearing age use reliable methods of contraception. Men are recommended to use a barrier method of contraception during treatment and for at least 90 days after its completion.
In animal studies, the drug was revealed teratogenicity. Ganciclovir primobolan cycle safety in pregnancy is not established in humans. Appointments of the drug to pregnant women should be avoided, unless the potential benefit to the mother is less than the potential risk to the fetus.
Peri- and postnatal development after exposure to ganciclovir has not been studied, but it is possible that ganciclovir may be displayed with milk and causing serious adverse reactions in the infant .Therefore, the decision to remove the drug or the termination of breastfeeding should be based on the potential positive effect of ganciclovir to a nursing mother.