Transcription of [Product Monograph Template - Schedule D]
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[Product Monograph Template - Schedule D]
TRESIBA ( insulin degludec injection) - Product Monograph Page 1 of 64 PRODUCT Monograph INCLUDING PATIENT MEDICATION INFORMATION TRESIBA insulin degludec injection TRESIBA FlexTouch 100 U/mL, Solution for injection in a pre-filled pen TRESIBA FlexTouch 200 U/mL, Solution for injection in a pre-filled pen Antidiabetic Agent Ultra-Long-Acting Basal insulin Analogue Novo Nordisk Canada Inc. 101-2476 Argentia Road Mississauga, Ontario Canada L5N 6M1 Date of Approval: July 17, 2018 Submission Control No: 208917 TRESIBA ( insulin degludec injection) -Product Monograph Page 2 of 64 Table of Contents PART I: HEALTH PROFESSIONAL INFORMATION .. 3 SUMMARY PRODUCT INFORMATION .. 3 3 INDICATIONS AND CLINICAL USE .. 3 CONTRAINDICATIONS .. 4 WARNINGS AND PRECAUTIONS.
TRESIBA® (insulin degludec injection) Product Monograph Page 4 of 64 . CONTRAINDICATIONS . TRESIBA® (insulin degludec injection) is contraindicated: • In patients who are hypersensitive to TRESIBA® (insulin degludec injection) or to any ingredient in the …
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