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besponsa route of administration

besponsa route of administration

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besponsa route of administration
Inotuzumab ozogamicin – SPS - Specialist Pharmacy Service , Welcome to BESPONSA® | BESPONSA®, Besponsa - FDA prescribing information, side effects and uses, Inotuzumab ozogamicin - Wikipedia, BESPONSA 1 mg powder for concentrate for solution for , BILLING AND CODING INFORMATION FOR HOSPITAL OUTPATIENT, , , .
01. Apr 12: NCT01564784 an open-label, randomized PIII study of inotuzumab ozogamicin vs a defined investigator´s choice in 292 adult patients with relapsed or refractory CD22-positive ALL. The primary outcome is response to therapy (% of patients achieving a complete response and complete response with incomplete platelet and/or neutrophil recovery). Inotuzumab ozogamicin will be given IV weekly (0.8-0.5 mg/m^2) 3 times per cycle. The comparator arms are: fludarabine, cytarabine and G-CSF or high dose cytarabine or cytarabine and mitoxantrone. The study will start in Jun 12 and is due to complete May 16 (primary outcome data available from Aug 14) [1]. · . 01. Apr 12: NCT01564784 an open-label, randomized PIII study of inotuzumab ozogamicin vs a defined investigator´s choice in 292 adult patients with relapsed or refractory CD22-positive ALL. The primary outcome is response to therapy (% of patients achieving a complete response and complete response with incomplete platelet and/or neutrophil recovery). Inotuzumab ozogamicin will be given IV weekly (0.8-0.5 mg/m^2) 3 times per cycle. The comparator arms are: fludarabine, cytarabine and G-CSF . The Food and Drug Administration approved BESPONSA based on the results of the clinical trial that showed treatment with BESPONSA compared to chemotherapy improved complete remission (CR) rates (36% vs 17%), length of CR (8.0 months vs 4.9 months), and minimal residual disease–negative CR rates (90% vs 32%)..
Besponsa is indicated for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). 2. DOSAGE AND ADMINISTRATION. In 2017 inotuzumab ozogamicin was approved by the European Commission and the FDA for the treatment of adults with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL) in 2017 under the trade name Besponsa (Pfizer/Wyeth). References. BESPONSA must be reconstituted and diluted before administration. For instructions on reconstitution and dilution of BESPONSA before administration, see section 6.6. For instructions on reconstitution and dilution of BESPONSA before administration, see section 6.6.. additional hour (List separately in addition 0.25 mg/mL of BESPONSA. to code for primary procedure) Include appropriate revenue code for the cost center in which the service is performed. Include appropriate CPT® code(s) for product administration service(s). BESPONSA is administered by 1-hour IV infusion. . .
 
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