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Asthma (Trial 1) Adverse Reaction Breo Ellipta 100/25 (n 201) Fluticasone Furoate 100 mcg (n 205) Placebo (n 203) Infections and infestations Nasopharyngitis 10 7 7 Oral candidiasisa. Exacerbation Trial In a 24- to 76-week trial, subjects received Breo Ellipta 100/25 (n 1,009) or fluticasone furoate 100 mcg (n 1,010) (Trial 5). How the dose, route, and duration of corticosteroid administration affect the risk of developing a disseminated infection is not known. What are the possible side effects of Breo Ellipta? Food and Drug Administration Revised: January 2019 principal display panel NDC Breo Ellipta 100/25 (fluticasone furoate 100 mcg and vilanterol 25 mcg inhalation powder) 100 mcg/25 mcg Rx Only FOR oral inhalation only Breo Ellipta contains 2 foil strips of 30 blisters each. The tray contains a desiccant to reduce moisture. The primary endpoint was change from baseline in weighted mean FEV1 (0 to 24 hours) at Week. If you open and close the cover without inhaling the medicine, you will lose the dose. Especially tell your healthcare provider if you take antifungal or anti-HIV medicines.
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ICS/laba did not show a significantly increased risk of a serious asthma-related event compared with ICS based on the pre-specified risk margin (2.7 with an estimated hazard ratio of time to first event.29 (95 CI:.73,.27). No evidence of structural abnormalities was observed at any dose in rats or in rabbits up to approximately 160 times the mrhdid (on an AUC basis at maternal doses up to 591 mcg/kg/day). Clinically significant cardiovascular effects and fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs. Deterioration of Disease and Acute Episodes Breo Ellipta should not be initiated in patients during rapidly deteriorating or potentially life-threatening episodes of copd or asthma. Although Breo Ellipta may control copd or asthma symptoms during these episodes, in recommended doses it supplies less than normal physiological amounts of glucocorticoid systemically and does NOT provide the mineralocorticoid activity that is necessary for coping with these emergencies. The safety data described below are based on the confirmatory 6- and 12-month trials.
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