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PRODUCT MONOGRAPH SYMBICORT …
COPYRIGHT 2002-2021 ASTRAZENECACANADA 1 of 58 PRODUCT MONOGRAPHPrSYMBICORT TURBUHALER budesonide/formoterol fumarate dihydrate dry powder for oral inhalationPrSYMBICORT 100 TURBUHALER 100 mcg budesonide and 6 mcgformoterol fumarate dihydratePrSYMBICORT 200 TURBUHALER 200 mcg budesonide and 6 mcg formoterol fumarate dihydratePrSYMBICORT FORTETURBUHALER 400 mcg budesonide and 12 mcg formoterolfumarate dihydrateCorticosteroid and bronchodilator for oral inhalationAstraZeneca Canada Middlegate RoadMississauga, OntarioL4Y of Revision: February 8, 2021 Submission Control No: 244507 SYMBICORT , SYMBICORT SMART , TURBUHALER , PULMICORT , OXEZE , and the AstraZeneca logo are registered trademarks of AstraZeneca AB, used under license by AstraZeneca Canada Inc. COPYRIGHT 2002-2021 ASTRAZENECACANADA 2 of 58 TABLE OF CONTENTSPART I: HEALTH PROFESSIONAL PRODUCT 3 INDICATIONS AND CLINICAL AND AND 23 ACTION AND CLINICAL AND HANDLING FORMS, COMPOSITION AND 26 PART II: SCIENTIFIC 28 CLINICAL 29 DETAILED III: CONSUMER 2002-2021 ASTRAZENECACANADA 3 of 58 PrSYMBICORT TURBUHALER budesonide/formoterol fumarate dihydratePART I: HEALTH PROFESSIONAL INFORMATIONSUMMARY PRODUCT INFORMATIONR oute of AdministrationDosage Form / StrengthNon-medicinalIngredientsOral inhalationDry powder for oral inhalation, Turbuhaler / 100 mcg budesonide / 6 mcg fo
indicated for the maintenance treatment of moderate to severe COPD including chronic bronchitis and emphysema, in patients with persistent symptoms and a history of exacerbations, where the use of a combination product is considered appropriate. SYMBICORTTURBUHALER is NOT indicated for the relief of acute bronchospasm in COPD patients.
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