LORAZEPAM SUBLINGUAL TABLET

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

LORAZEPAM

Mevcut itibaren:

AA PHARMA INC

ATC kodu:

N05BA06

INN (International Adı):

LORAZEPAM

Doz:

0.5MG

Farmasötik formu:

TABLET

Kompozisyon:

LORAZEPAM 0.5MG

Uygulama yolu:

SUBLINGUAL

Paketteki üniteler:

100/500

Reçete türü:

Targeted (CDSA IV)

Terapötik alanı:

BENZODIAZEPINES

Ürün özeti:

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

Yetkilendirme durumu:

APPROVED

Yetkilendirme tarihi:

2013-08-14

Ürün özellikleri

_Lorazepam Sublingual (lorazepam) _
_ _
_Page 1 of 33 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
LORAZEPAM SUBLINGUAL
Lorazepam Sublingual Tablets
Tablets, 0.5 mg, 1 mg and 2 mg, Sublingual
Anxiolytic - Sedative
Submission Control Number: 274298
AA PHARMA INC.
1165 Credistone Road, Unit #1
Vaughan, Ontario
L4K 4N7
Date of Initial Authorization:
OCT 16, 2013
Date of Revision:
JUN 21, 2023
_Lorazepam Sublingual (lorazepam) _
_ _
_Page 2 of 33 _
RECENT MAJOR LABEL CHANGES
1 INDICATIONS, 1.2 Geriatrics
06/2023
3 SERIOUS WARNINGS AND PRECAUTIONS BOX
06/2023
4 DOSAGE AND ADMINISTRATION, 4.1 Dosing
Considerations
06/2023
4 DOSAGE AND ADMINISTRATION, 4.2 Recommended
Dose and Dosage Adjustment
06/2023
7 WARNINGS AND PRECAUTIONS
06/2023
7 WARNINGS AND PRECAUTIONS, 7.1.4 Geriatrics
06/2023
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
.....................................................................................
1
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
..................................................................................
5
4.1
Dosing Considerations
.............................