Nebenwirkungen · Elebrato Ellipta
Elebrato Ellipta 92 micrograms/55 micrograms/22 micrograms inhalation powder, pre-dispensed · Abschnitt 4.8 · PDF-Seite 9
HOS-141964 · Präparat HOS-098720
In a 52-week study, with a total of 10 355 patients with COPD and a history of moderate or severe exacerbations within the prior 12 months (mean post-bronchodilator screening FEV1 46% of predicted, SD 15%) (study CTT116855), the incidence of pneumonia was 8% (317 patients) for Elebrato Ellipta (n = 4 151), 7% (292 subjects) for fluticasone furoate/vilanterol (n = 4 134), and 5% (97 subjects) for umeclidinium/vilanterol (n = 2 070). Fatal pneumonia occurred in 12 of 4 151 patients (3.5 per 1 000 patient- years) receiving Elebrato Ellipta, 5 of 4 134 patients (1.7 per 1 000 patient-years) receiving fluticasone furoate/vilanterol, and 5 of 2 070 patients (2.9 per 1 000 patient-years) receiving umeclidinium/vilanterol.
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Version 2026-05-08T12:09:00Z · SHA-256 5921a8b45eff5f6f74f973b971b75b80cf50431a4e47b20e906f127e6f0ef9a0 · Passage 3dd541f24ee571ec7890b9fe25fc6b193e186b1060f47e055500ae77d799eb70 · Zeichen 4725–5449 im Abschnitt