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It is an oral anti-cytomegalovirus infection drug developed by the Swiss company Roche. Its main ingredient is valganciclovir hydrochloride. It is currently used to treat induction therapy of CMV retinitis, maintenance therapy of CMV retinitis and prevention of CMV infection in transplant patients. In addition, on August 11, 2010, Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced that the U.S. Food and Drug Administration (FDA) approved valganciclovir hydrochloride tablets (Valcyte) for the treatment of adult kidney transplant patients at high risk of cytomegalovirus (CMV) disease.

Roche announced on August 31, 2009 that the U.S. Food and Drug Administration (FDA) has approved Valcyte (trade name: Valcyte; generic name: valganciclovir hydrochloride) for the prevention of cytomegalovirus (CMV) infection in pediatric kidney and heart transplant patients aged 4 months to 16 years. Such children are considered to be a high-risk group for CMV infection.

When Valganciclovir Hydrochloride Tablets are used to prevent CMV infection in adult patients after organ transplantation, for kidney transplant patients, the recommended dose is 900 mg (two 450 mg tablets), once a day, starting within 10 days after transplantation and continuing until 200 days after transplantation. For patients who have received a solid organ transplant other than a kidney, the recommended dose is 900 mg (two 450 mg tablets) once daily, starting within 10 days after transplantation and continuing until 100 days after transplantation.

Precautions: Acute Renal Failure: Acute renal failure may occur, ensure adequate hydration, use with caution in patients receiving concomitant nephrotoxic drugs. Hematological disorders: Severe leukopenia, neutropenia, anemia, thrombocytopenia, pancytopenia, and bone marrow failure, including aplastic anemia. May occur at any time during treatment and worsen with continued use; cell counts usually begin to recover within 3-7 days of stopping treatment. Do not use if the absolute neutrophil count is <500 cells/MM3, platelet count <25,000/m3, or hemoglobin <8 g/dl; use with caution in patients with myelosuppression, cytopenia, or patients receiving myelosuppressive drugs/radiation. Monitor CBC and platelet counts at baseline and frequently during treatment, especially in infants and patients with renal impairment, patients with prior drug-induced leukopenia, and patients with neutrophil counts <1000 cells/mm3 at the start of treatment.