Riik: Kanada
keel: inglise
Allikas: Health Canada
RASAGILINE (RASAGILINE MESYLATE)
MINT PHARMACEUTICALS INC
N04BD02
RASAGILINE
0.5MG
TABLET
RASAGILINE (RASAGILINE MESYLATE) 0.5MG
ORAL
100
Prescription
Active ingredient group (AIG) number: 0151662001; AHFS:
APPROVED
2022-12-21
_MINT-RASAGILINE _ _Page 1 of 45_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION Pr MINT-RASAGILINE Rasagiline Tablets Tablet, 0.5 mg and 1 mg (as rasagiline mesylate), Oral Professed Standard Antiparkinson Agent Mint Pharmaceuticals Inc. 6575 Davand Drive Mississauga, Ontario L5T 2M3 Date of Initial Authorization: December 20, 2022 Submission Control Number: 250188 _ _ _MINT-RASAGILINE _ _Page 2 of 45_ RECENT MAJOR LABEL CHANGES None at the time of authorization 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 ........................................................... 5 4 DOSAGE AND ADMINISTRATION ................................................................................ 5 4.1 Dosing Considerations ............................................................................................. 5 4.2 Recommended Dose and Dosage Adjustment ........................................................ 5 4.4 Administration ......................................................................................................... 6 4.5 Missed Dose ........ Lugege kogu dokumenti