Valsts: Kanāda
Valoda: angļu
Klimata pārmaiņas: Health Canada
RASAGILINE (RASAGILINE MESYLATE)
TEVA CANADA LIMITED
N04BD02
RASAGILINE
1MG
TABLET
RASAGILINE (RASAGILINE MESYLATE) 1MG
ORAL
30
Prescription
MONOAMINE OXIDASE B INHIBITORS
Active ingredient group (AIG) number: 0151662002; AHFS:
APPROVED
2021-06-03
_AZILECT (rasagiline) _ _Page 1 of 48 _ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION Pr AZILECT ® Rasagiline Tablets Tablet, 0.5 mg and 1 mg (as rasagiline mesylate), Oral Professed Standard Antiparkinson Agent Teva Canada Limited Toronto, Ontario, M1B 2K9 Manufactured for: Teva Canada Innovation Montreal, Quebec H2Z 1S8 Date of Initial Authorization: August 17, 2006 Date of Revision: February 10, 2022 Submission Control Number: 255783 _ _ _AZILECT (rasagiline) _ _Page 2 of 48 _ RECENT MAJOR LABEL CHANGES 2 Contraindications 02/2022 7 Warnings and Precautions 02/2022 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................................................................................. 6 4.1 Dosing Considerations ....................................................................................... 6 4.2 Recommended Dose and Dosage Adjustment..................................................... 6 4.4 Administration............................................ Izlasiet visu dokumentu