PMS-LORAZEPAM TABLET

Land: Kanada

Sprache: Englisch

Quelle: Health Canada

Wirkstoff:

LORAZEPAM

Verfügbar ab:

PHARMASCIENCE INC

ATC-Code:

N05BA06

INN (Internationale Bezeichnung):

LORAZEPAM

Dosierung:

1MG

Darreichungsform:

TABLET

Zusammensetzung:

LORAZEPAM 1MG

Verabreichungsweg:

ORAL

Einheiten im Paket:

100

Verschreibungstyp:

Targeted (CDSA IV)

Therapiebereich:

BENZODIAZEPINES

Produktbesonderheiten:

Active ingredient group (AIG) number: 0110731001; AHFS:

Berechtigungsstatus:

MARKETED

Berechtigungsdatum:

1988-12-31

Fachinformation

_pms-LORAZEPAM (lorazepam) _
_Page 1 of 36_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PMS-LORAZEPAM
Lorazepam Tablets
Tablets, 0.5 mg, 1 mg and 2 mg, Oral
USP
Anxiolytic – Sedative
PHARMASCIENCE INC.
6111 Royalmount Avenue, Suite #100
Montréal, Québec, Canada
H4P 2T4
www.pharmascience.com
Submission Control Number: 272351
Date of Initial Authorization:
APR 04, 2001
Date of Revision:
MAY 9, 2023
_pms-LORAZEPAM (lorazepam) _
_Page 2 of 36_
RECENT MAJOR LABEL CHANGES
4 DOSAGE AND ADMINISTRATION, 4.1 Dosing Considerations
05/2023
4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dosage and Dosage
Adjustment
05/2023
7 WARNINGS AND PRECAUTIONS, Dependence/Tolerance
05/2023
7 WARNINGS AND PRECAUTIONS, Withdrawal
05/2023
7 WARNINGS AND PRECAUTIONS, Risks from Concomitant use of Opioids and
Benzodiazepines
05/2023
7 WARNINGS AND PRECAUTIONS, 7.1. Special Populations, 7.1.4 Geriatrics
05/2023
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
7 WARNINGS AND PRECAUTIONS
12/2021
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
1
INDICATIONS
..............................................................................................................
4
1.1
Pediatrics
...................................................................................................................
4
1.2
Geriatrics
...................................................................................................................
4
2
CONTRAINDICATIONS
.................................................................................................
4
3
SERIOUS WARNINGS AND PR