Maa: Kanada
Kieli: englanti
Lähde: Health Canada
RASAGILINE (RASAGILINE MESYLATE)
ASCEND LABORATORIES LTD
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
2019-06-04
PRODUCT MONOGRAPH Pr ASN-RASAGILINE RASAGILINE MESYLATE 0.5 MG AND 1 MG RASAGILINE TABLETS (AS RASAGILINE MESYLATE) ANTIPARKINSON AGENT Ascend Laboratories Ltd. 35 Nixon Road, Unit 10 Caledon, Ontario L7E 1K1 Date of Preparation: May 30, 2019 Control Number: 221339 2 TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION .........................................................3 SUMMARY PRODUCT INFORMATION ........................................................................3 INDICATIONS AND CLINICAL USE ..............................................................................3 CONTRAINDICATIONS ...................................................................................................3 WARNINGS AND PRECAUTIONS ..................................................................................4 ADVERSE REACTIONS ..................................................................................................10 DRUG INTERACTIONS ..................................................................................................15 DOSAGE AND ADMINISTRATION ..............................................................................16 OVERDOSAGE ................................................................................................................18 ACTION AND CLINICAL PHARMACOLOGY ............................................................19 STORAGE AND STABILITY ..........................................................................................21 DOSAGE FORMS, COMPOSITION AND PACKAGING .............................................21 PART II: SCIENTIFIC INFORMATION ...............................................................................23 PHARMACEUTICAL INFORMATION ..........................................................................23 CLINICAL TRIALS ..........................................................................................................23 DETAILED PHARMACOLOGY .....................................................................................28 T Lue koko asiakirja