ATIVAN TABLET

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

LORAZEPAM

Dostopno od:

PFIZER CANADA ULC

Koda artikla:

N05BA06

INN (mednarodno ime):

LORAZEPAM

Odmerek:

0.5MG

Farmacevtska oblika:

TABLET

Sestava:

LORAZEPAM 0.5MG

Pot uporabe:

ORAL

Enote v paketu:

100/500

Tip zastaranja:

Targeted (CDSA IV)

Terapevtsko območje:

BENZODIAZEPINES

Povzetek izdelek:

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

Status dovoljenje:

APPROVED

Datum dovoljenje:

2003-04-02

Lastnosti izdelka

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