LORAZEPAM INJECTION USP SOLUTION

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

LORAZEPAM

Boleh didapati daripada:

SANDOZ CANADA INCORPORATED

Kod ATC:

N05BA06

INN (Nama Antarabangsa):

LORAZEPAM

Dos:

2MG

Borang farmaseutikal:

SOLUTION

Komposisi:

LORAZEPAM 2MG

Laluan pentadbiran:

INTRAMUSCULAR

Unit dalam pakej:

1ML

Jenis preskripsi:

Targeted (CDSA IV)

Kawasan terapeutik:

BENZODIAZEPINES

Ringkasan produk:

Active ingredient group (AIG) number: 0110731002; AHFS:

Status kebenaran:

MARKETED

Tarikh kebenaran:

2015-11-12

Ciri produk

LORAZEPAM INJECTION USP Product Monograph
_ _
Page 1 of 34
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
C/T
LORAZEPAM INJECTION USP
Lorazepam
Injection, 4 mg/mL, intravenous, intramuscular
USP
Anxiolytic – Sedative
Sandoz Canada Inc.
110 Rue de Lauzon
Boucherville, QC, Canada
J4B 1E6
Date of Initial Authorization:
JUN 6, 2001
Date of Revision:
JAN. 7, 2022
Submission Control No.: 255105
LORAZEPAM INJECTION USP Product Monograph
_ _
Page 2 of 34
RECENT MAJOR LABEL CHANGES
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
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
.............................................................. 5
4
DOSAGE AND
ADMINISTRATION...................................................................................
5
4.1
Dosing Considerations
........................................................................................
5
4.2
R