Maa: Kanada
Kieli: englanti
Lähde: Health Canada
INSULIN DEGLUDEC
NOVO NORDISK CANADA INC
A10AE06
INSULIN DEGLUDEC
100UNIT
SOLUTION
INSULIN DEGLUDEC 100UNIT
SUBCUTANEOUS
5X3ML
Schedule D
LONG-ACTING INSULINS
Active ingredient group (AIG) number: 0159410001; AHFS:
APPROVED
2017-08-25
_ _ _Product Monograph Master Template _ _Template Date: September 2020 _ _TRESIBA_ _® _ _(insulin degludec injection _ _Page 1 of 68_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION TRESIBA ® insulin degludec injection TRESIBA ® Penfill ® 100 U/mL, Solution for injection in a cartridge 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 Subcutaneous Antidiabetic Agent Long-Acting Basal Insulin Analogue ATC Code: A10AE06 Novo Nordisk Canada Inc. 101-2476 Argentia Road Mississauga, Ontario Canada L5N 6M1 Date of Initial Authorization: AUG 25, 2017 Date of Revision: OCT 27, 2022 Submission Control Number: 258642 _ _ _Product Monograph Master Template _ _Template Date: September 2020 _ _TRESIBA_ _® _ _(insulin degludec injection _ _Page 2 of 68_ RECENT MAJOR LABEL CHANGES 7 Warnings and Precautions 03/2021 7 Warnings and Precautions, 7.11 Pregnant Women 11/2021 TABLE OF CONTENTS SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF AUTHORIZATION ARE NOT LISTED. RECENT MAJOR LABEL CHANGES .................................................................................... 2 TABLE OF CONTENTS ......................................................................................................... 2 PART I: HEALTH PROFESSIONAL INFORMATION.............................................................. 4 1 INDICATIONS............................................................................................................. 4 1.1 Pediatrics .......................................................................................................... 4 1.2 Geriatrics........................................................................................................... 4 2 CONTRAINDICATIONS .............................................................................................. 4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX..................................................... 4 4 DOSAGE AND ADMINIS Lue koko asiakirja