TEVA-LORAZEPAM TABLET

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

LORAZEPAM

제공처:

TEVA CANADA LIMITED

ATC 코드:

N05BA06

INN (International Name):

LORAZEPAM

복용량:

0.5MG

약제 형태:

TABLET

구성:

LORAZEPAM 0.5MG

관리 경로:

ORAL

패키지 단위:

100/500/1000

처방전 유형:

Targeted (CDSA IV)

치료 영역:

BENZODIAZEPINES

제품 요약:

Active ingredient group (AIG) number: 0110731003; AHFS:

승인 상태:

APPROVED

승인 날짜:

2013-12-06

제품 특성 요약

TEVA-LORAZEPAM Page 1 of 33
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
TEVA-LORAZEPAM
Lorazepam Tablets
Tablets, 0.5 mg, 1 mg, 2 mg, Oral
Teva Standard
Anxiolytic-Sedative
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
Canada M1B 2K9
www.tevacanada.com
Date of Initial Authorization:
March 05, 1985
Date of Revision:
March 24, 2023
Submission Control No.: 271985
TEVA-LORAZEPAM Page 2 of 33
RECENT MAJOR LABEL CHANGES
1 Indications
03/2023
1 Indications, 1.2 Geriatrics
12/2021
3 Serious Warnings and Precautions Box
12/2021
4 Dosage and Administration, 4.1 Dosing Considerations
12/2021
4 Dosage and Administration, 4.2 Recommended Dose and Dosage
Adjustment
03/2023
7 Warnings and Precautions
03/2023
7 Warnings and Precautions, 7.1.4 Geriatrics
12/2021
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
........................................................................
4
4 DOSAGE AND
ADMINISTRATION…………………………………�