国: カナダ
言語: 英語
ソース: Health Canada
GLUCAGON (RECOMBINANT DNA ORIGIN) (GLUCAGON HYDROCHLORIDE)
NOVO NORDISK CANADA INC
H04AA01
GLUCAGON
1MG
KIT
GLUCAGON (RECOMBINANT DNA ORIGIN) (GLUCAGON HYDROCHLORIDE) 1MG
INTRAMUSCULAR
1ML
Schedule D
GLYCOGENOLYTIC AGENTS
Active ingredient group (AIG) number: 0142861001; AHFS:
APPROVED
2009-09-17
_ _ _Product Monograph Master Template _ _Template Date: September 2020 _ _GLUCAGEN_ _®_ _ and GLUCAGEN_ _®_ _ HYPOKIT (glucagon) _ _Page 1 of 41_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION GLUCAGEN ® and GLUCAGEN ® HYPOKIT glucagon ATC Code: H04AA01 Powder and solvent for solution for injection, 1 mg, Intramuscularly Hyperglycemic Agent Manufactured by: Novo Nordisk Canada Inc. 101-2476 Argentia Road Mississauga, Ontario L5N 6M1 Canada Distributed by: Paladin Labs Inc. St-Laurent, QC H4M 2P2 Date of Initial Approval: JUN-01-2016 Date of Revision: FEB-01-2022 Submission Control No: 256817 _ _ _Product Monograph Master Template _ _Template Date: September 2020 _ _GLUCAGEN_ _®_ _ and GLUCAGEN_ _®_ _ HYPOKIT (glucagon) _ _Page 2 of 41_ RECENT MAJOR LABEL CHANGES 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 ADMINISTRATION ............................................................................. 5 4.1 Dosing Considerations ................................................................................... 完全なドキュメントを読む