APO-LORAZEPAM TABLET

Ország: Kanada

Nyelv: angol

Forrás: Health Canada

Aktív összetevők:

LORAZEPAM

Beszerezhető a:

APOTEX INC

ATC-kód:

N05BA06

INN (nemzetközi neve):

LORAZEPAM

Adagolás:

0.5MG

Gyógyszerészeti forma:

TABLET

Összetétel:

LORAZEPAM 0.5MG

Az alkalmazás módja:

ORAL

db csomag:

100/500

Recept típusa:

Targeted (CDSA IV)

Terápiás terület:

BENZODIAZEPINES

Termék összefoglaló:

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

Engedélyezési státusz:

MARKETED

Engedély dátuma:

1985-12-31

Termékjellemzők

_APO-LORAZEPAM (Lorazepam Tablets) Page 1 of 33 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
APO-LORAZEPAM
Lorazepam Tablets
Tablets, 0.5 mg, 1 mg and 2 mg, Oral
USP
Anxiolytic - Sedative
APOTEX INC.
150 Signet Drive
Toronto Ontario
M9L 1T9
Date of Initial Authorization:
JUL 31, 2018
Date of Revision:
MAY 9, 2023
Submission Control Number: 272962
_APO-LORAZEPAM (Lorazepam Tablets) Page 2 of 33 _
RECENT MAJOR LABEL CHANGES
1 INDICATIONS, 1.2 Geriatrics
01/2022
3 SERIOUS WARNINGS AND PRECAUTIONS BOX
01/2022
4 DOSAGE AND ADMINISTRATION, 4.1 Dosing Considerations
01/2022
4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose
and Dosage Adjustment
05/2023
7 WARNINGS AND PRECAUTIONS, Dependence/Tolerance
05/2023
7 WARNINGS AND PRECAUTIONS, 7.1.4 Geriatrics
01/2022
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
...................................................................................
5
4.1
Dosing Considerations
..................................................