Kraj: Kanada
Język: angielski
Źródło: Health Canada
RASAGILINE (RASAGILINE MESYLATE)
ANGITA PHARMA INC.
N04BD02
RASAGILINE
0.5MG
TABLET
RASAGILINE (RASAGILINE MESYLATE) 0.5MG
ORAL
100
Prescription
MONOAMINE OXIDASE B INHIBITORS
Active ingredient group (AIG) number: 0151662001; AHFS:
APPROVED
2021-04-09
_Product Monograph of AG-Rasagiline _ _Page 1 of 49 _ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR AG-RASAGILINE Rasagiline Tablets Tablet, 0.5 mg and 1 mg rasagiline (as rasagiline mesylate), Oral Antiparkinson Agent Angita Pharma Inc. 1310, rue Nobel Date of Initial Authorization: Boucherville, Quebec APR 09, 2021 J4B 5H3, Canada Date of Revision: MAY 25, 2023 Control Number: 275105 _Product Monograph of AG-Rasagiline _ _Page 2 of 49 _ RECENT MAJOR LABEL CHANGES 2 Contraindications 05/2023 7 Warnings and Precautions 05/2023 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 .............................. Przeczytaj cały dokument