MIDAZOLAM INJECTION USP SOLUTION

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

MIDAZOLAM

Tilgjengelig fra:

PFIZER CANADA ULC

ATC-kode:

N05CD08

INN (International Name):

MIDAZOLAM

Dosering :

1MG

Legemiddelform:

SOLUTION

Sammensetning:

MIDAZOLAM 1MG

Administreringsrute:

INTRAMUSCULAR

Enheter i pakken:

2ML/5ML

Resept typen:

Targeted (CDSA IV)

Terapeutisk område:

BENZODIAZEPINES

Produkt oppsummering:

Active ingredient group (AIG) number: 0119935002; AHFS:

Autorisasjon status:

APPROVED

Autorisasjon dato:

2017-10-25

Preparatomtale

_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
..............................................................................................................
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
...........................