Country: Canada
Language: English
Source: Health Canada
RIVASTIGMINE (RIVASTIGMINE HYDROGEN TARTRATE)
KNIGHT THERAPEUTICS INC.
N06DA03
RIVASTIGMINE
3MG
CAPSULE
RIVASTIGMINE (RIVASTIGMINE HYDROGEN TARTRATE) 3MG
ORAL
56/60
Prescription
PARASYMPATHOMEMETIC (CHOLINERGIC) AGENTS
Active ingredient group (AIG) number: 0140521002; AHFS:
APPROVED
2022-11-03
_ _ EXELON® (Rivastigmine hydrogen tartrate) _ _ _Page 1 of 57_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION Pr EXELON® Rivastigmine Capsules Capsules, 1.5 mg, 3 mg, 4.5 mg, 6 mg Rivastigmine (as rivastigmine hydrogen tartrate), oral Manufacturer’s standard Rivastigmine Oral Solution Solution, 2mg/mL Rivastigmine (as rivastigmine hydrogen tartrate), oral Cholinesterase Inhibitor Knight Therapeutics Inc. 3400 De Maisonneuve W., Suite 1055 Montreal, QC Canada H3Z 3B8 Date of Initial Authorization: NOV 02, 2022 Date of Revision: OCT 03, 2023 Submission Control Number: 273941 EXELON is a registered trademark. _ _ EXELON® (Rivastigmine hydrogen tartrate) _ _ _Page 2 of 57_ RECENT MAJOR LABEL CHANGES 2 CONTRAINDICATIONS [10/2023] 7 WARNINGS AND PRECAUTIONS, Cardiovascular [10/2023] TABLE OF CONTENTS 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 4 DOSAGE AND ADMINISTRATION .................................................................................. 4 4.1 Dosing Considerations ........................................................................................... 5 4.2 Recommended Dose and Dosage Adjustment ....................................................... 5 4.4 Adminis Read the complete document