去纤苷是啥时候上市的?
The FDA approved defibrotide (defiteli) to treat adult and pediatric patients with hepatic veno-occlusive disease (VOD), also known as sinusoidal obstructive syndrome (SOS), and renal or pulmonary dysfunction following hematopoietic stem cell transplantation (HSCT). Hepatic veno-occlusive disease (HVOD) is one of the serious complications after hematopoietic stem cell transplantation (HSCT), and the mortality rate in patients with severe HVOD can be as high as 100%. Defibrotide (defiteli) is a single-stranded oligonucleotide mixture with anti-thrombotic and fibrinolysis-promoting effects. In recent years, multiple clinical research results have shown that defibrotide (defiteli) is a safe and effective drug for preventing and treating HVOD after HSCT. The recommended dose of defibrotide (defiteli) for adult and pediatric patients is 6.25 mg/kg given every 6 hours as a 2-hour intravenous infusion. The dose should be based on the patient's baseline weight, which is defined as the patient's weight before the HSCT preparation protocol. Give defibrotide (defiteli) for a minimum of 21 days. If signs and symptoms of hepatic VOD do not resolve after 21 days, continue defibrination until resolution of VOD or up to a maximum of 60 days.
Defibrotide (defiteli) was first developed by Gentium Pharmaceuticals in Italy and was approved for marketing in the EU in October 2013. After Gentium Pharmaceuticals was acquired by Jazz Pharmaceuticals of the United States, defibrotide (defiteli) was approved by the U.S. Food and Drug Administration (FDA) for marketing in the United States on March 30, 2016. According to the editor's knowledge, defibrotide (defiteli) is not on the market in my country, and patients need to buy it from abroad at the original price. If patients need medicine, they can go to the place of origin of defiteli to purchase it in person. However, this method is suitable for patients with better family conditions. Ordinary families can choose to obtain it from regular domestic medical service institutions, such as Medical Companion Travel. It can help patients obtain genuine and guaranteed defibrotide (defiteli sodium, defiteli), and the medicine will be delivered directly to their homes, so patients do not have to worry about the source of the medicine.
[ 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)