ATIVAN TABLET

Land: Kanada

Tungumál: enska

Heimild: Health Canada

Virkt innihaldsefni:

LORAZEPAM

Fáanlegur frá:

PFIZER CANADA ULC

ATC númer:

N05BA06

INN (Alþjóðlegt nafn):

LORAZEPAM

Skammtar:

0.5MG

Lyfjaform:

TABLET

Samsetning:

LORAZEPAM 0.5MG

Stjórnsýsluleið:

SUBLINGUAL

Einingar í pakka:

100

Gerð lyfseðils:

Targeted (CDSA IV)

Lækningarsvæði:

BENZODIAZEPINES

Vörulýsing:

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

Leyfisstaða:

APPROVED

Leyfisdagur:

2003-04-02

Vara einkenni

_Product Monograph _
_ _
_ATIVAN (lorazepam) _
_Page 1 of 32 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
ATIVAN
®
Lorazepam
Tablets, 0.5 mg, 1 mg, 2 mg, Oral
Tablets, 0.5 mg, 1 mg, 2 mg, Sublingual
Anxiolytic-Sedative
Pfizer Canada ULC
17,300 Trans Canada Highway
Kirkland, QC H9J 2M5
Date of Initial Authorization:
FEB 4, 1977
Date of Revision:
DEC 28, 2022
Submission Control Number: 267182
®
T.M. Wyeth
Pfizer Canada ULC, Licensee
©
Pfizer Canada ULC
_ _
_Product Monograph _
_ _
_ATIVAN (lorazepam) _
_Page 2 of 32 _
RECENT MAJOR LABEL CHANGES
1 INDICATIONS, 1.2 Geriatrics
3 SERIOUS WARNINGS AND PRECAUTIONS BOX
4 DOSAGE AND ADMINISTRATION, 4.1 Dosing Considerations
4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dosage and
Dosage Adjustment
7 WARNINGS AND PRECAUTIONS, Dependence/Tolerance
7 WARNINGS AND PRECAUTIONS, Withdrawal
7 WARNINGS AND PRECAUTIONS, Immune
7 WARNINGS AND PRECAUTIONS, Neurologic, Falls and Fractures
7 WARNINGS AND PRECAUTIONS, Risks from Concomitant use of
Opioids and Benzodiazepines
7 WARNINGS AND PRECAUTIONS, 7.1. Special Populations, 7.1.3
Pediatrics
7 WARNINGS AND PRECAUTIONS, 7.1. Special Populations, 7.1.4
Geriatrics
12/2022
3 SERIOUS WARNINGS AND PRECAUTIONS BOX, Addiction, Abuse
and Misuse
4 DOSAGE AND ADMINISTRATION, 4.1 Dosing Considerations
4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dosage and
Dosage Adjustment
7 WARNINGS AND PRECAUTIONS, Withdrawal
12/2022
_ _
_Product Monograph _
_ _
_ATIVAN (lorazepam) _
_Page 3 of 32 _
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
..............................................................................................................
3
PART I: HEALTH PROFESSIONAL INFORMATION
.....................................................................
5
1
INDICATIONS
..............................................................