LORAZEPAM INJECTION USP SOLUTION

Ország: Kanada

Nyelv: angol

Forrás: Health Canada

Aktív összetevők:

LORAZEPAM

Beszerezhető a:

SANDOZ CANADA INCORPORATED

ATC-kód:

N05BA06

INN (nemzetközi neve):

LORAZEPAM

Adagolás:

2MG

Gyógyszerészeti forma:

SOLUTION

Összetétel:

LORAZEPAM 2MG

Az alkalmazás módja:

INTRAMUSCULAR

db csomag:

1ML

Recept típusa:

Targeted (CDSA IV)

Terápiás terület:

BENZODIAZEPINES

Termék összefoglaló:

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

Engedélyezési státusz:

MARKETED

Engedély dátuma:

2015-11-12

Termékjellemzők

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