Prescribing information

 

       

Screenshot of fact sheet for the ARGON study

Fact sheet for the ARGON study: Gessner C et al. 2020

Non-inferiority of high-dose IND/GLY/MF (once-daily) vs concurrent administration of high-dose SAL/FLU (twice-daily) + TIO (once-daily) in terms of AQLQ score.1

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Screenshot of fact sheet for the QUARTZ study

Fact sheet for the QUARTZ study: Kornmann O et al. 2020

Efficacy and safety of inhaled once-daily low-dose indacaterol acetate/mometasone furoate (IND/MF) in patients with inadequately controlled asthma: Phase III randomised QUARTZ study findings.2

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Screenshot of Fact sheet for Azzie 2017

Fact sheet for Azzi E et al. 2017

Practice makes perfect: self-reported adherence a positive marker of inhaler technique maintenance3

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Screenshot for Fact sheet for Buhl 2019

Fact sheet for Buhl R et al. 2019

One-year follow-up of asthmatic patients newly initiated on treatment with medium- or high-dose long-acting beta2-agonist/inhaled corticosteroid (LABA/ICS) in UK primary care settings4

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Screenshot for Fact sheet for IRIDIUM study

Fact sheet for the IRIDIUM study: Kerstjens H et al. 2020. 

Once-daily inhaled fixed dose combination (FDC) of indacaterol/glycopyrronium/mometasone (IND/GLY/MF) significantly improved lung function vs long-acting beta2-agonist/inhaled corticosteroid (LABA/ICS) FDC in patients with inadequately controlled asthma5

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Screenshot for Fact sheet for PALLADIUM study

Fact sheet for the PALLADIUM study: van Zyl-Smit R et al. 2020

Once-daily inhaled fixed dose combination of indacaterol/mometasone furoate (IND/MF) provides significant improvements across key asthma outcomes vs inhaled corticosteroid monotherapy6

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Indications: ENERZAIR® BREEZHALER® (indacaterol acetate/glycopyrronium bromide/mometasone furoate inhalation powder) is indicated as a maintenance treatment for asthma in adult patients not adequately controlled with a maintenance combination of a long-acting beta2-agonist and a high dose of an inhaled corticosteroid, who experienced one or more asthma exacerbations in the previous year.7

ATECTURA® BREEZHALER® is indicated as a maintenance treatment of asthma in adults and adolescents 12 years of age and older not adequately controlled with inhaled corticosteroids and inhaled short-acting beta2-agonists.8

AQLQ, asthma quality of life questionnaire; FDC, fixed-dose combination; FLU, fluticasone propionate; GLY, glycopyrronium; ICS, inhaled corticosteroid; IND, indacaterol; LABA, long acting beta agonist; MF, mometasone furoate SAL, salmeterol xinafoate; TIO, tiotropium.

References

  1. Gessner C, et al. Respir Med 2020;106021..
  2. Kornmann O, et al. Respir Med 2020;161:105809 [Epub ahead of print].
  3. Azzi E, et al. NPJ Prim Care Respir Med 2017;27:29.
  4. Buhl R, et al. Respir Med 2019;162:105859 [Epub ahead of print].  
  5. Kerstjens H, et al. Lancet Respir Med 2020;8(10):1000–1012.
  6. van Zyl-Smit R, et al. Lancet Respir Med 2020;8(10):987–999.
  7. ENERZAIR® BREEZHALER®. Summary of Product Characteristics. 
  8. ATECTURA® BREEZHALER®. Summary of Product Characteristics.
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UK | February 2021 | 103407
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Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Novartis via [email protected] or online through the pharmacovigilance intake (PVI) tool at www.report.novartis.com
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