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PRODUCT MONOGRAPH Master TemplateTemplate date: September 2020 FORXIGA (dapagliflozin propanediol monohydrate)Page 1 of 75 COPYRIGHT 2014-2021 ASTRAZENECA CANADA INCPRODUCT MONOGRAPHINCLUDING PATIENT MEDICATION INFORMATIONFORXIGA Dapagliflozin propanediol monohydrateTablets, 5 mg and 10 mg, OralATC Code: A10BK01 Sodium-glucose co-transporter 2 ( sglt2 ) inhibitorsAstraZeneca Canada Middlegate RoadMississauga, OntarioL4Y of Initial Authorization:Dec 10, 2014 Date of Revision:Aug 06, 2021 Submission Control Number: 248367 FORXIGA is a registered trademark of AstraZeneca AB, used under license byAstraZeneca Canada MONOGRAPH Master TemplateTemplate date: September 2020 FORXIGA (dapagliflozin propanediol monohydrate)Page 2 of 75 COPYRIGHT 2014-2021 ASTRAZENECA CANADA INCRECENT MAJOR LABEL CHANGES1 INDICATIONS08/20212 CONTRAINDICATIONS08/20214 DOSAGE AND ADMINISTRATION, Dosing Considerations08/20214 DOSAGE AND ADMINISTRATION, Recommended Dose and Dosage Adjustm
Clinical trial and post-market cases of diabetic ketoacidosis (DKA), a serious life-threatening ... FORXIGA and other sodium-glucose co-transporter 2 (SGLT2) inhibitors. A number of these cases have been atypical with blood glucose values below 13.9 mmol/L (250 mg/dL). ... In patients with chronic kidney disease, the recommended dose of FORXIGA ...
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