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 .. 4 ADVERSE REACTIONS .. 8 DRUG INTERACTIONS .. 16 DOSAGE AND ADMINISTRATION .. 17 OVERDOSAGE .. 20 ACTION AND CLINICAL PHARMACOLOGY .. 20 STORAGE AND STABILITY .. 23 SPECIAL HANDLING INSTRUCTIONS.
TRESIBA® (insulin degludec injection) -Product Monograph Page 2 of 64. Table of Contents PART I: HEALTH PROFESSIONAL INFORMATION..... 3 SUMMARY PRODUCT INFORMATION.....
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