PRO-LORAZEPAM TABLET

Ország: Kanada

Nyelv: angol

Forrás: Health Canada

Aktív összetevők:

LORAZEPAM

Beszerezhető a:

PRO DOC LIMITEE

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:

APPROVED

Engedély dátuma:

2022-03-22

Termékjellemzők

_PRO-LORAZEPAM (Lorazepam Tablets) _
_ _
_Page 1 of 33 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PRO-LORAZEPAM
Lorazepam Tablets
Tablets, 0.5 mg, 1 mg and 2 mg, Oral
USP
Anxiolytic - Sedative
PRO DOC LTÉE
2925, boul. Industriel
Laval Québec
H7L 3W9
Date of Initial Authorization:
OCT 15, 1985
Date of Revision:
AUG 10, 2023
Submission Control Number: 277413
_PRO-LORAZEPAM (Lorazepam Tablets) _
_ _
_Page 2 of 33 _
RECENT MAJOR LABEL CHANGES
1 INDICATIONS, 1.2 Geriatrics
03/2022
3 SERIOUS WARNINGS AND PRECAUTIONS BOX
03/2022
4 DOSAGE AND ADMINISTRATION, 4.1 Dosing Considerations
03/2022
4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose
and Dosage Adjustment
08/2023
7 WARNINGS AND PRECAUTIONS, Dependence/Tolerance
08/2023
7 WARNINGS AND PRECAUTIONS, 7.1.4 Geriatrics
03/2022
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
.............................