Страна: Канада
мова: англійська
Джерело: Health Canada
INSULIN ASPART
NOVO NORDISK CANADA INC
A10AB05
INSULIN ASPART
100UNIT
SOLUTION
INSULIN ASPART 100UNIT
SUBCUTANEOUS
3ML
Schedule D
INSULINS
Active ingredient group (AIG) number: 0144802001; AHFS:
CANCELLED POST MARKET
2023-08-16
_ _ _Product Monograph Master Template _ _Template Date: September 2020 _ _NovoRapid_ _® _ _Insulin Aspart _ _Page 1 of 52_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION NOVORAPID ® Insulin Aspart Solution for Injection, 100 Units/mL, Subcutaneous Injection Professed Standard Anti-diabetic Agent ATC code: A10AB05 fast-acting Novo Nordisk Canada Inc. 101-2476 Argentia Road Mississauga, Ontario L5N 6M1 Canada Date of Initial Authorization: APR 06, 2018 Date of Revision: AUG 12, 2021 Submission Control Number: 251029 _ _ _Product Monograph Master Template _ _Template Date: September 2020 _ _NovoRapid_ _® _ _Insulin Aspart _ _Page 2 of 52_ RECENT MAJOR LABEL CHANGES 4.4 Administration 03/2021 7 Warnings and Precautions 03/2021 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 1 INDICATIONS............................................................................................................. 4 1.1 Pediatrics .......................................................................................................... 4 1.2 Geriatrics........................................................................................................... 4 2 CONTRAINDICATIONS .............................................................................................. 4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX..................................................... 4 4 DOSAGE AND ADMINISTRATION ............................................................................. 5 4.1 Dosing Considerations ....................................................................................... 5 4.2 Recommended Dose and Dosage Adjustment ................................................... 5 4.4 Administration......................... Прочитайте повний документ