去纤苷保存要求

On October 22, 2013, defibrotide (also called defibrotide sodium) was approved for marketing by the European Union. As the first treatment for severe hepatic veno-occlusive disease in adults and children undergoing hematopoietic stem cell transplantation, it was developed by Gentium Pharmaceuticals of Italy. After Gentium Pharmaceuticals was acquired by Jazz Pharmaceuticals of the United States, defibrinoside was approved by the U.S. Food and Drug Administration (FDA) for marketing in the United States on March 30, 2016. Today we will learn more about the storage requirements of defibrinoside.

Defibrotide (also called defibrotide sodium) is an injectable form and should be stored at 20°C-25°C (68°F-77°F); excursions allowed between 15°C and 30°C (59°F and 86°F). When stored at room temperature, diluted defibrinoside should be used within 4 hours. It is best to keep defibrinoside (Defibrotide) out of the reach of children to avoid accidental ingestion.

The recommended dose of defibrotide for adult and pediatric patients is 6.25 mg/kg given every 6 hours as a 2-hour intravenous infusion. Give defibrinoside (also called defibrotide sodium) for a minimum of 21 days. If signs and symptoms of hepatic VOD have not resolved after 21 days, continue defibrotide until resolution of VOD or up to a maximum of 60 days. Must be diluted before infusion.

Defibrotide is an adenosine receptor agonist with multiple effects. The adenosine A1/A2 receptors of endothelial cells are involved in the regulation of endothelial cells and the response of endothelial cells to injury. Defibrotide can act on these receptors to produce a variety of downstream effects.

Defibrotide is the first drug approved by the FDA for the treatment of severe hepatic venule occlusion, a rare and fatal liver disease. The approval was based on a Phase 2 trial of 75 patients, a Phase 3 trial of 102 patients, and an expansion trial of an additional 351 patients. All patients in the trial were diagnosed with hepatic veno-occlusive disease and associated renal or pulmonary dysfunction after HSCT (hematopoietic stem cell transplantation).

In the Phase 2 trial, 44% of patients survived 100 days after transplantation, compared with 38% in the Phase 3 trial and 45% in the expanded trial, and the FDA noted in a report that the expected 100-day survival rate for patients with severe hepatic veno-occlusive disease who were not treated with defibrotide (also called defibrotide sodium) was 21%-31%.

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