APO-RASAGILINE TABLET

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

RASAGILINE (RASAGILINE MESYLATE)

제공처:

APOTEX INC

ATC 코드:

N04BD02

INN (International Name):

RASAGILINE

복용량:

1MG

약제 형태:

TABLET

구성:

RASAGILINE (RASAGILINE MESYLATE) 1MG

관리 경로:

ORAL

패키지 단위:

15G/50G

처방전 유형:

Prescription

치료 영역:

MONOAMINE OXIDASE B INHIBITORS

제품 요약:

Active ingredient group (AIG) number: 0151662002; AHFS:

승인 상태:

APPROVED

승인 날짜:

2016-01-11

제품 특성 요약

_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
..................................................