TEVA-LORAZEPAM TABLET

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

LORAZEPAM

Tersedia dari:

TEVA CANADA LIMITED

Kode ATC:

N05BA06

INN (Nama Internasional):

LORAZEPAM

Dosis:

0.5MG

Bentuk farmasi:

TABLET

Komposisi:

LORAZEPAM 0.5MG

Rute administrasi :

ORAL

Unit dalam paket:

100/500/1000

Jenis Resep:

Targeted (CDSA IV)

Area terapi:

BENZODIAZEPINES

Ringkasan produk:

Active ingredient group (AIG) number: 0110731003; AHFS:

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2013-12-06

Karakteristik produk

TEVA-LORAZEPAM Page 1 of 33
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
TEVA-LORAZEPAM
Lorazepam Tablets
Tablets, 0.5 mg, 1 mg, 2 mg, Oral
Teva Standard
Anxiolytic-Sedative
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
Canada M1B 2K9
www.tevacanada.com
Date of Initial Authorization:
March 05, 1985
Date of Revision:
March 24, 2023
Submission Control No.: 271985
TEVA-LORAZEPAM Page 2 of 33
RECENT MAJOR LABEL CHANGES
1 Indications
03/2023
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
4 Dosage and Administration, 4.2 Recommended Dose and Dosage
Adjustment
03/2023
7 Warnings and Precautions
03/2023
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……………………………………………………………………………………………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
........................................................................
4
4 DOSAGE AND
ADMINISTRATION…………………………………�