ATIVAN TABLET

País: Canadá

Língua: inglês

Origem: Health Canada

Ingredientes ativos:

LORAZEPAM

Disponível em:

PFIZER CANADA ULC

Código ATC:

N05BA06

DCI (Denominação Comum Internacional):

LORAZEPAM

Dosagem:

2MG

Forma farmacêutica:

TABLET

Composição:

LORAZEPAM 2MG

Via de administração:

ORAL

Unidades em pacote:

100/1000

Tipo de prescrição:

Targeted (CDSA IV)

Área terapêutica:

BENZODIAZEPINES

Resumo do produto:

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

Status de autorização:

APPROVED

Data de autorização:

2003-04-02

Características técnicas

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