MIDAZOLAM INJECTION USP SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

MIDAZOLAM

Available from:

PFIZER CANADA ULC

ATC code:

N05CD08

INN (International Name):

MIDAZOLAM

Dosage:

5MG

Pharmaceutical form:

SOLUTION

Composition:

MIDAZOLAM 5MG

Administration route:

INTRAMUSCULAR

Units in package:

1/2ML

Prescription type:

Targeted (CDSA IV)

Therapeutic area:

BENZODIAZEPINES

Product summary:

Active ingredient group (AIG) number: 0119935001; AHFS:

Authorization status:

APPROVED

Authorization date:

2012-03-23

Summary of Product characteristics

_Product Monograph - Midazolam Injection USP (Preservative-Free) _
_Page 1 of 47_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
MIDAZOLAM INJECTION USP
Midazolam
Solution, 1 mg / mL and 5 mg / mL, Intramuscular, Intravenous
Preservative-Free
Benzodiazepine
Premedicant-Sedative-Anesthetic Agent
Pfizer Canada ULC
17300 Trans-Canada Highway
Kirkland, Québec
H9J 2M5
Date of Initial Authorization:
MAR 26, 2012
Date of Revision:
JAN 3, 2023
Submission Control Number: 266098
_ _
_Product Monograph - Midazolam Injection USP (Preservative-Free) _
_Page 2 of 47_
RECENT MAJOR LABEL CHANGES
1 INDICATIONS, 1.2 Geriatrics
01/2023
3 SERIOUS WARNINGS AND PRECAUTIONS BOX
01/2023
4 DOSAGE AND ADMINISTRATION, 4.1 Dosing Considerations
01/2023
4 DOSAGE AND ADMINISTRATION, 4.5 Missed Dose
01/2023
7 WARNINGS AND PRECAUTIONS, General
01/2023
7 WARNINGS AND PRECAUTIONS, Dependence/Tolerance
01/2023
7 WARNINGS AND PRECAUTIONS, Falls and Fractures
01/2023
7 WARNINGS AND PRECAUTIONS, 7.1.4 Geriatrics
01/2023
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
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2
PART I: HEALTH PROFESSIONAL INFORMATION
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4
1
INDICATIONS
..............................................................................................................
4
1.1
Pediatrics
..........................................................................................................
4
1.2
Geriatrics...........................................................................................................
4
2
CONTRAINDICATIONS
.................................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
...........................