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besponsa storage

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Besponsa - FDA prescribing information, side effects and uses, Besponsa Dosage Guide - Drugs.com, Welcome to BESPONSA® | BESPONSA®, BESPONSA 1 mg powder for concentrate for solution for , Inotuzumab ozogamicin – SPS - Specialist Pharmacy Service , Besponsa (Inotuzumab ozogamicin) Drug / Medicine Information, , , .
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 ].. Storage Times and Conditions for Reconstituted and Diluted Besponsa Solution Maximum time from reconstitution through end of administration less than or equal to 8 hours * Diluted Solution. Storage Times and Conditions for Reconstituted and Diluted BESPONSA Solution Maximum time from reconstitution through end of administration less than or equal to 8 hours * Diluted Solution.
BESPONSA is a prescription medicine used to treat adults with relapsed or refractory B-cell acute lymphoblastic leukemia (ALL). It is not known if BESPONSA is safe and effective in children under 18 years of age.. Storage times and conditions for reconstituted and diluted BESPONSA solution Maximum time from reconstitution through the end of administration ≤ 8 hours a Reconstituted solution. 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].. Besponsa is used to treat adults with acute lymphoblastic leukaemia (ALL). ALL is a cancer of the blood where the cells that help protect your body from infection and foreign materials (white . . .
 
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