盐酸缬更昔洛韦片什么时候上市的呢?
The tablet is the L-valyl ester (prodrug) of ganciclovir, which is rapidly converted into ganciclovir by esterases in the small intestine and liver after oral administration. Valganciclovir hydrochloride tablets are a synthetic 2’-deoxyguanylate analogue that inhibits herpes virus replication in vitro and in vivo.
When were valganciclovir hydrochloride tablets launched?
In May 2001, the US FDA approved the marketing of Valcyte. It is clinically used to treat acute retinitis caused by CMV infection in patients with acquired immunodeficiency syndrome. In May 2003, its indications were expanded. Valcyte is used to prevent and treat secondary CMV infection in organ transplant recipients. 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 for 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.
1. Induction treatment of CMV retinitis: For patients with active CMV retinitis, the recommended dose is 900 mg (two 450 mg tablets) twice a day for 21 days. Prolonged induction therapy may increase the risk of bone marrow toxicity. 2. Maintenance treatment of CMV retinitis: After induction therapy, or for patients with inactive CMV retinitis, the recommended dose is 900 mg (two 450 mg tablets) once daily. Induction therapy may be repeated in patients with worsening retinitis. 3. Prevention of CMV infection in transplant patients: For kidney transplant patients, the recommended dose of Valcyte is 900 mg (two 450 mg tablets), once a day, starting within 10 days after transplantation 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.
[ 免责声明 ] 本页面内容来自公开渠道(如FDA官网、Drugs官网、原研药厂官网等),仅供持有医疗专业资质的人员用于医学药学研究参考,不构成任何治疗建议或药品推荐。所涉药品可能未在中国大陆获批上市,不适用于中国境内销售和使用。如需治疗,请咨询正规医疗机构。本站不提供药品销售或代购服务。
.jpeg)