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: Not indicated for relief of acute bronchospasm ( , , ) ----------------------DOSAGE AND ADMINISTRATION----------------------- For oral inhalation only To receive the full dose of medication, SPIRIVA RESPIMAT must be administered as two inhalations once-daily.
Immediate hypersensitivity reactions, including urticaria, angioedema (including swelling of the lips, tongue or throat), rash, bronchospasm, anaphylaxis, or itching may occur after administration of SPIRIVA RESPIMAT. If such a reac tion occurs, therapy with SPIRIVA RESPIMAT should be stopped at once and alternative treatments should be considered.
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