Suppression of bone marrow function generally reversible generally reversible and dose dependent expected and will likely increase the risk of infection, including severe sepsis. Administering Clolar leads to a rapid reduction in peripheral leukemia cells. Patients should evaluated and monitored for signs and symptoms of tumor lysis syndrome and cytokine release , Concomitant use response syndrome / capillary leak syndrome, and organ failure may develop to be monitored. Clolar at at clinically significant signs or symptoms of SIRS or capillary leak syndrome.. Clolar should be administered under the supervision of a qualified physician in the use of antineoplastic therapy experienced physician.
This press release contains forward-looking statements, including statements about the potential administration, dosing and therapeutic benefit of Clolar in various cancer indications, the planned timetable and registration for clinical trials of Clolar and the locations of such studies and the requirements and plans for regulatory submissions and approvals for Clolar in additional indications. Uncertainties include,tainties include, among others: the timing of discussions with the FDA regarding clinical trials and approval of Clolar in additional indications; Genzyme engage the ability of cooperative Clolar conduct clinical trials of Clolar and the ability of all test centers to patients enroll in the respective study.Ltd. Makes at first the New Drug Application for oral factor Xa inhibitor in, edoxaban.
Daiichi Sankyo Company announced that it Limited today that a New Drug Application in order Ministry of Health, work and welfare Japan license is one of anticoagulans, edoxaban presented for prevention of venous thromboembolism undergoing major orthopedic surgery.
– ENGAGE AF-TIMI 48: study edoxaban once a day against warfarin more than 16,500 patients with atrial fibrillation for prevention of strokes and systemic embolism. ENGAGE AF-TIMI 48 started to registration in late 2008.