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besponsa administration

besponsa administration

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besponsa administration
Besponsa - FDA prescribing information, side effects and uses, Welcome to BESPONSA® | BESPONSA®, Besponsa Dosage Guide - Drugs.com, Dosing | BESPONSA™ (inotuzumab ozogamicin) | Safety Info, BESPONSA 1 mg powder for concentrate for solution for , FDA approves new treatment for adults with relapsed or , FDA Approves Besponsa (Inotuzumab Ozogamicin) for Acute , , .
In a female fertility and early embryonic development study, female rats were administered daily intravenous doses of inotuzumab ozogamicin up to 0.11 mg/m2 for 2 weeks before mating through Day 7 of pregnancy. An increase in the proportion of resorptions and decrease in the number of viable embryos and gravid uterine weights were observed at the 0.11 mg/m2 dose level (approximately 2 times the exposure in patients at the maximum recommended dose, based on AUC). Additional findings in female reproductive organs occurred in repeat-dose toxicology studies and included decreased ovarian and uterine weights, and ovarian and uterine atrophy. Findings in male reproductive organs occurred in repeat-dose toxicology studies and included decreased testicular weights, testicular degeneration, hypospermia, and prostatic and seminal vesicle atrophy. Testicular degeneration and hypospermia were nonreversible following a 4-week nondosing period. In the chronic studies of 26-weeks duration, adverse effects on reproductive organs occurred at ≥0.07 mg/m2 in male rats and at 0.73 mg/m2 in female monkeys [see ].. Besponsa is indicated for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). 2. DOSAGE AND ADMINISTRATION Recommended Dosage. Pre-medicate before each dose [see Dosage and Administration (2.2)].. 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%)..
Detailed dosage guidelines and administration information for Besponsa (inotuzumab ozogamicin). Includes dose adjustments, warnings and precautions.. See risks & benefits. Find information for healthcare professionals about dosing and administration for BESPONSA™.. 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.. The U.S. Food and Drug Administration today approved Besponsa (inotuzumab ozogamicin) for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).. The US Food and Drug Administration has approved the targeted therapy drug Besponsa (inotuzumab ozogamicin) for adults with B-cell precursor acute lymphoblastic leukemia (ALL) that is not getting better with treatment, or came back after treatment. B-cell precursor ALL is a type of cancer in which. .
 
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