EXELON SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

RIVASTIGMINE (RIVASTIGMINE HYDROGEN TARTRATE)

Available from:

KNIGHT THERAPEUTICS INC.

ATC code:

N06DA03

INN (International Name):

RIVASTIGMINE

Dosage:

2MG

Pharmaceutical form:

SOLUTION

Composition:

RIVASTIGMINE (RIVASTIGMINE HYDROGEN TARTRATE) 2MG

Administration route:

ORAL

Units in package:

120 ML

Prescription type:

Prescription

Therapeutic area:

PARASYMPATHOMEMETIC (CHOLINERGIC) AGENTS

Product summary:

Active ingredient group (AIG) number: 0140521005; AHFS:

Authorization status:

APPROVED

Authorization date:

2022-11-03

Summary of Product characteristics

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EXELON® (Rivastigmine hydrogen tartrate)
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_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