Land: Canada
Sprog: engelsk
Kilde: Health Canada
RASAGILINE (RASAGILINE MESYLATE)
APOTEX INC
N04BD02
RASAGILINE
0.5MG
TABLET
RASAGILINE (RASAGILINE MESYLATE) 0.5MG
ORAL
15G/50G
Prescription
MONOAMINE OXIDASE B INHIBITORS
Active ingredient group (AIG) number: 0151662001; AHFS:
APPROVED
2016-01-11
_APO-RASAGILINE (Rasagiline Mesylate Tablets) Page 1 of 52 _ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR APO-RASAGILINE Rasagiline Mesylate Tablets Tablets, 0.5 mg and 1 mg rasagiline (as rasagiline mesylate), Oral Antiparkinson Agent APOTEX INC. 150 Signet Drive Toronto, Ontario M9L 1T9 Date of Initial Authorization: JAN 11, 2016 Date of Revision: SEP 22, 2023 Submission Control Number: 274257 _APO-RASAGILINE (Rasagiline Mesylate Tablets) Page 2 of 52 _ RECENT MAJOR LABEL CHANGES 2 CONTRAINDICATIONS 09/2023 7 WARNINGS AND PRECAUTIONS 09/2023 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 ................................................................. 5 1 INDICATIONS ............................................................................................................... 5 1.1 Pediatrics ................................................................................................................. 5 1.2 Geriatrics ................................................................................................................. 5 2 CONTRAINDICATIONS ................................................................................................. 5 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................................ 6 4 DOSAGE AND ADMINISTRATION ................................................................................. 7 4.1 Dosing Considerations ............................................................................................. 7 4.2 Recommended Dose and Dosage Adjustment ........................................................ 7 4.4 Administration .................................................. Læs hele dokumentet