APO-ALPRAZ TABLET
국가: 캐나다
언어: 영어
출처: Health Canada
제품 특성 요약
(SPC)
03-11-2021
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유효 성분:
ALPRAZOLAM
제공처:
APOTEX INC
ATC 코드:
N05BA12
INN (국제 이름):
ALPRAZOLAM
복용량:
1MG
약제 형태:
TABLET
구성:
ALPRAZOLAM 1MG
관리 경로:
ORAL
패키지 단위:
100
처방전 유형:
Targeted (CDSA IV)
치료 영역:
BENZODIAZEPINES
제품 요약:
Active ingredient group (AIG) number: 0115008003; AHFS:
승인 상태:
APPROVED
승인 날짜:
2001-03-29
제품 특성 요약
Page 1 of 41
PRODUCT MONOGRAPH
APO-ALPRAZ
ALPRAZOLAM TABLETS USP
0.25 MG, 0.5 MG AND 1.0 MG TABLETS
APO-ALPRAZ TS
ALPRAZOLAM TABLETS USP 2 MG TRISCORED TABLETS
ANXIOLYTIC-ANTIPANIC
APOTEX INC.
DATE OF REVISION:
150 SIGNET DRIVE
November 3, 2021
TORONTO, ONTARIO
M9L 1T9
Submission Control No: 256073
Page 2 of 41
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
............................................................ 3
SUMMARY PRODUCT INFORMATION
................................................................................................................
3
INDICATIONS AND CLINICAL USE
......................................................................................................................
3
CONTRAINDICATIONS
...........................................................................................................................................
5
WARNINGS AND PRECAUTIONS
..........................................................................................................................
5
ADVERSE REACTIONS
.........................................................................................................................................
13
DRUG INTERACTIONS
..........................................................................................................................................
16
DOSAGE AND ADMINISTRATION
......................................................................................................................
20
OVERDOSAGE
........................................................................................................................................................
22
ACTION AND CLINICAL PHARMACOLOGY
....................................................................................................
22
STORAGE AND STABILITY
..................................................................................................................................
23
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................
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