ADVAIR DISKUS ADVAIR - GlaxoSmithKline

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Table 3 Number (and percentage) of patients with drug-related adverse events (incidence ≥ 1% 1 ) (Safety Population) Adverse events Salmeterol xinafoate/fluticasone propionate MDI combination product Fluticasone propionate alone Salmeterol xinafoate alone Placebo Number of patients 622 614 274 176 Any event 67 (11 %) 71 (11 %) 29 (11%) 9 (5%) Hoarseness/dysphonia 13 (2 %) 7 (1 %) 3 (2 %) 0 (0 %) Throat irritation 13 (2 %) 14 (2 %) 10 (4 %) 3 (2 %) Candidiasis of mouth and throat 8 (1 %) 8 (1 %) 0 (0 %) 1 (
The following table includes all events (whether considered drug-related or non drugrelated by the investigator) that occurred at a rate of 3% or greater in either of the groups receiving <strong>ADVAIR</strong> ® <strong>DISKUS</strong> ® and were more common than in the placebo group. July 29, 2014 Page 19 of 67
Page 1 and 2: Pr ADVAIR ® DISKUS ® salmeterol x
Page 3 and 4: Pr ADVAIR ® DISKUS ® salmeterol x
Page 5 and 6: WARNINGS AND PRECAUTIONS General In
Page 7 and 8: Endocrine And Metabolism Systemic S
Page 9 and 10: The results of a drug interaction s
Page 11 and 12: Ophthalmologic (Glaucoma and Catara
Page 13 and 14: Since there is no experience with u
Page 15 and 16: MedDRA preferred term Musculoskelet
Page 17: Table 2 Number (and percentage) of
Page 21 and 22: Other COPD Clinical Trial Adverse D
Page 23 and 24: Very rare: Anaphylactic shock or an
Page 25 and 26: Drug-Drug Interactions Table 5 Esta
Page 27 and 28: Recommended Dose And Dosage Adjustm
Page 29 and 30: trauma, surgery or infection or any
Page 31 and 32: significant increase in plasma salm
Page 33 and 34: ADVAIR ® inhalation aerosol compri
Page 35 and 36: Partition Coefficient: The partitio
Page 37 and 38: In a randomized, double-blind, acti
Page 39 and 40: ADVAIR ® / ADVAIR ® DISKUS ® are
Page 41 and 42: Study Demographics and Trial Design
Page 43 and 44: consistent with the recommended use
Page 45 and 46: Clinical Studies in COPD Clinical s
Page 47 and 48: There was no evidence that the syst
Page 49 and 50: man. The change was characterized b
Page 51 and 52: Focal coronary arteritis occurred t
Page 53 and 54: 11. Greening AP, Ind PW, Northfield
Page 55 and 56: IMPORTANT: PLEASE READ WARNINGS AND
Page 57 and 58: IMPORTANT: PLEASE READ Then go on a
Page 59 and 60: IMPORTANT: PLEASE READ SERIOUS SIDE
Page 61 and 62: IMPORTANT: PLEASE READ PART III: CO
Page 63 and 64: IMPORTANT: PLEASE READ INTERACTIONS
Page 65 and 66: IMPORTANT: PLEASE READ SIDE EFFECTS
Page 67: IMPORTANT: PLEASE READ This is not

ADVAIR DISKUS ADVAIR - GlaxoSmithKline

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