ONE LABA/LAMA
STANDS ALONE
#1
THE ONLY LABA/LAMA INDICATED FOR THE
REDUCTION OF EXACERBATIONS IN COPD 1
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ULTIBRO ®
BREEZHALER ®
110/50
ULTIBRO ® BREEZHALER ® 110/50 is indicated as a once-daily maintenance bronchodilator
treatment to relieve symptoms in patients with chronic obstructive pulmonary disease (COPD)
and for the reduction of exacerbations of COPD in patients with a history of exacerbations. 1
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LABA: long-acting ß 2 -agonist. LAMA: long-acting muscarinic antagonist. COPD: chronic obstructive pulmonary disease. FEV 1 : forced expiratory volume in 1 second. CI: confidence interval. RRR: relative risk reduction.
PBS Information: Authority required (STREAMLINED).
Chronic obstructive pulmonary disease (COPD). Refer to PBS Schedule for full authority information.
STREAMLINED AUTHORITY CODE 5763. Please review Product Information before prescribing.
Full Product Information is available at http://www.novartis.com.au/products_healthcare.html
ULTIBRO ® BREEZHALER ® 110/50 (indacaterol maleate/glycopyrronium bromide (glycopyrrolate)). INDICATION: Once-daily maintenance bronchodilator treatment
to relieve symptoms in patients with COPD, and for the reduction of exacerbations of COPD in patients with a history of exacerbations. DOSAGE: 110/50µg once daily using only
the BREEZHALER inhaler. Do not swallow capsules. CONTRAINDICATIONS: Hypersensitivity to any ingredients, galactose intolerance, severe lactase deficiency or glucose-
galactose malabsorption. PRECAUTIONS: Should not be used in asthma, LABA may increase the risk of asthma-related SAEs, including deaths. Should not be used as rescue
therapy. Administration may result in paradoxical bronchospasm that may be life-threatening. If this or hypersensitivity occurs, discontinue immediately and institute alternative
therapy. Use with caution in patients with narrow-angle glaucoma and urinary retention. Discontinue when acute narrow-angle glaucoma occur. Monitor for hyperplasia or bladder-
neck obstruction. Use with caution in patients with CV disorders, convulsive disorders or thyrotoxicosis; and those unusually responsive to ß 2 -agonists. Use only if expected benefit
outweighs potential risk in patients with severe renal impairment including end-stage renal disease requiring dialysis. Indacaterol may produce a clinically significant CV effect as
measured by increases in pulse rate, BP, and/or symptoms, ECG changes. May produce significant hypokalemia, which has the potential to produce adverse CV effects. In severe
COPD, hypokalemia may be potentiated by hypoxia and concomitant treatment may increase the susceptibility to cardiac arrhythmias. More clinically notable changes in blood