Transcription of Boehringer Ingelheim
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Boehringer Ingelheim
HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use SPIRIVA RESPIMAT safely and effectively. See full prescribing information for SPIRIVA RESPIMAT. SPIRIVA RESPIMAT (tiotropium bromide) inhalation spray, for oral inhalation Initial Approval: 2004 ----------------------------RECENT MAJOR CHANGES-------------------------- Indications and Usage ( ) 2/2017 ----------------------------INDICATIONS AND USAGE--------------------------- SPIRIVA RESPIMAT is an anticholinergic indicated for: The long-term, once-daily, maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), and for reducing COPD exacerbations ( ) The long-term, once-daily, maintenance treatment of asthma in patients 6 years of age and older ( ) Limitation of Use.
the 7 randomized, parallel-group, double-blind, placebo-controlled studies of 4-48 weeks in treatment duration. These trials included 6565 adult COPD patients (75% males and 25% females) 40 years of age and older. Of these pa tients, 3282 patients were treated with SPIRIVA RESPIMAT 5 mcg and 3283 received placebo. The
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