valgansiklovir说明书

[Common name] Valganciclovir ()

[Drug name] Valcyte

【Main Ingredients】 Valganciclovir Hydrochloride

[Drug Properties] Tablets, this product is a pink oval film-coated oral tablet.  

[Indications] Valganciclovir hydrochloride tablets are suitable for the treatment of acquired immunodeficiency syndrome (AIDS) combined with cytomegalovirus (CMV) retinitis.  

[Usage and Dosage] Adult patients should use Vancevir tablets instead of Vancevir oral solution. Oral solutions and tablets should be taken with food. Vancevir tablets should not be broken or crushed. Before dispensing medication to patients, pharmacists must prepare oral solution (50 mg/ml) with Vancevi. Recommended dose in adults with normal renal function: Treatment of induction of cytomegalovirus retinitis: The recommended dose is 900 mg (two 450 mg tablets) twice daily for 21 days. Maintenance: After induction therapy, or in adult patients with inactive cytomegalovirus retinitis, the recommended dose is 900 mg orally once daily. Cytomegalovirus prophylaxis: For adult patients who have received a heart or kidney-pancreas transplant, the recommended dose is 900 mg orally once daily starting within 10 days of transplantation and continuing until 100 days after transplantation. For adult patients who have received a kidney transplant, the recommended dose is 900 mg taken orally once daily starting within 10 days after transplantation and until 200 days after transplantation. Recommended Dosage in Pediatric Patients: Cytomegalovirus (CMV) Prophylaxis in Pediatric Renal Transplant Patients: For pediatric renal transplant patients 4 months to 16 years of age, the recommended once-daily mg dose (7 × BSA (bovine serum albumin) × CrCl (creatinine clearance)) should be initiated within 10 days after transplantation and continued until 200 days after transplantation. Prophylaxis of Cytomegalovirus (CMV) in Pediatric Heart Transplant Patients: For pediatric heart transplant patients 1 month to 16 years of age, a once-daily mg dose (7 × BSA (bovine serum albumin) × CrCl (creatinine clearance)) is recommended starting within 10 days after transplantation and continuing until day 100 after transplantation.  

[Adverse reactions] Clinical study results on Valganciclovir tablets Valganciclovir tablets are the prodrug of ganciclovir and are rapidly converted into ganciclovir after oral administration. Therefore, known adverse reactions associated with ganciclovir are expected to occur with valganciclovir. All adverse events observed in clinical studies of valganciclovir tablets have been previously observed with ganciclovir. In a clinical trial in which 79 patients in each group were randomly treated with valganciclovir tablets or intravenous ganciclovir for 28 days (21 days of induction treatment and 7 days of maintenance treatment), the safety data of the two groups were comparable. The most frequently reported adverse events were diarrhea, neutropenia, and pyrexia. Diarrhea, oral candida infection, headache, and fatigue were more commonly reported in the oral valganciclovir group, whereas nausea and injection site-related events were more commonly reported in the intravenous ganciclovir group.  

[Storage] Valganciclovir () should be stored at 30°C. Medicines should be stored out of the reach of children.