ADVAIR DISKUS ADVAIR - GlaxoSmithKline

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STORAGE AND STABILITY ADVAIR ® DISKUS ® Do not store ADVAIR ® DISKUS ® above 25°C. Keep in a dry place. ADVAIR ® inhalation aerosol Replace the mouthpiece cover firmly and snap it into position. Store ADVAIR ® inhalation aerosol between 15°C and 25°C. Protect from frost and direct sunlight. SPECIAL HANDLING INSTRUCTIONS ADVAIR ® inhalation aerosol Contents under pressure. Container may explode if heated. Do not place in hot water or near radiators, stoves, or other sources of heat. Even when apparently empty, do not puncture or incinerate container or store at temperatures over 25°C. As with most inhaled medications in pressurized canisters, the therapeutic effect of this medication may decrease when the canister is cold. DOSAGE FORMS, COMPOSITION AND PACKAGING ADVAIR ® DISKUS ® ADVAIR ® DISKUS ® (salmeterol xinafoate/fluticasone propionate) is a dry powder plastic inhaler device containing a foil strip with 28 or 60 regularly placed blisters each containing 50 mcg of salmeterol (as the xinafoate salt), and 100, 250 or 500 mcg of fluticasone propionate per inhalation. It also contains lactose (milk sugar), including milk protein, which acts as the “carrier”. ADVAIR ® inhalation aerosol ADVAIR ® inhalation aerosol is a pressurized metered-dose inhaler (MDI) consisting of an aluminum canister fitted with a metering valve. Each canister is fitted into the supplied purple actuator/adaptor. A dust cap is fitted over the actuator’s mouthpiece when not in use. July 29, 2014 Page 32 of 67
ADVAIR ® inhalation aerosol comprises a suspension of salmeterol and fluticasone propionate in the propellant HFA-134a (1,1,1,2-tetrafluoroethane). It contains no excipients. ADVAIR ® inhalation aerosol delivers 25 mcg of salmeterol and 50*, 125 or 250 mcg of fluticasone propionate per actuation. Available in 120 dose formats. *ADVAIR ® 50 is not available in Canada July 29, 2014 Page 33 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 and 18: Table 2 Number (and percentage) of
Page 19 and 20: The following table includes all ev
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: significant increase in plasma salm
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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