MIDAZOLAM INJECTION SOLUTION

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

MIDAZOLAM

Boleh didapati daripada:

SANDOZ CANADA INCORPORATED

Kod ATC:

N05CD08

INN (Nama Antarabangsa):

MIDAZOLAM

Dos:

1MG

Borang farmaseutikal:

SOLUTION

Komposisi:

MIDAZOLAM 1MG

Laluan pentadbiran:

INTRAMUSCULAR

Unit dalam pakej:

2/5/10ML

Jenis preskripsi:

Targeted (CDSA IV)

Kawasan terapeutik:

BENZODIAZEPINES

Ringkasan produk:

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

Status kebenaran:

APPROVED

Tarikh kebenaran:

2005-10-05

Ciri produk

_MIDAZOLAM INJECTION (midazolam) _
_ _
_Page 1 of 53 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
T/C
MIDAZOLAM INJECTION
Midazolam
Solution, 1 mg/mL and 5 mg/mL, Intramuscular, Intravenous
Sandoz Standard
Benzodiazepine
Premedicant-Sedative-Anesthetic Agent
Sandoz Canada Inc.
110 rue de Lauzon
Boucherville, Quebec, Canada
J4B 1E6
Date of Initial Authorization:
July 21, 1999
Date of Revision:
November 12, 2021
Submission Control Number: 250748
_MIDAZOLAM INJECTION (midazolam) _
_ _
_Page 2 of 53 _
RECENT MAJOR LABEL CHANGES
1 Indications, 1.2 Geriatrics
11/2021
3 Serious Warnings and Precautions
11/2021
4 Dosage and Administration, 4.1 Dosing Considerations
11/2021
4 Dosage and Administration, 4.5 Missed Dose
11/2021
7 Warnings and Precautions
11/2021
7 Warnings and Precautions, 7.1.4 Geriatrics
11/2021
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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TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL INFORMATION
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1
1
INDICATIONS
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1.1
Pediatrics
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4
1.2
Geriatrics
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2
CONTRAINDICATIONS
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SERIOUS WARNINGS AND PRECAUTIONS BOX .................. Error!
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DOSAGE AND ADMINISTRATION .......................................
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4.1
Dosing Considerations ................................................
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4.2
Re