LORAZEPAM INJECTION USP SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

LORAZEPAM

Available from:

SANDOZ CANADA INCORPORATED

ATC code:

N05BA06

INN (International Name):

LORAZEPAM

Dosage:

4MG

Pharmaceutical form:

SOLUTION

Composition:

LORAZEPAM 4MG

Administration route:

INTRAMUSCULAR

Units in package:

1 ML

Prescription type:

Targeted (CDSA IV)

Therapeutic area:

BENZODIAZEPINES

Product summary:

Active ingredient group (AIG) number: 0110731004; AHFS:

Authorization status:

APPROVED

Authorization date:

2005-08-12

Summary of Product characteristics

LORAZEPAM INJECTION USP _(lorazepam)_
_ _
Page 1 of 35
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:
JUL 18, 2023
Submission Control No.: 272297
LORAZEPAM INJECTION USP _(lorazepam)_
_ _
Page 2 of 35
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
07/2023
4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dosage and
Dosage Adjustment
07/2023
7 WARNINGS AND PRECAUTIONS
12/2021
7 WARNINGS AND PRECAUTIONS, Dependence/Tolerance
07/2023
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
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2
TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL INFORMATION
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4
1
INDICATIONS
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4
1.1
Pediatrics
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4
1.2
Geriatrics
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4
2
CONTRAINDICATIONS
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4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
............................................................. 5
4
DOSAGE AND ADMINISTRATION
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