LORAZEPAM SUBLINGUAL TABLET

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

LORAZEPAM

Disponibil de la:

AA PHARMA INC

Codul ATC:

N05BA06

INN (nume internaţional):

LORAZEPAM

Dozare:

0.5MG

Forma farmaceutică:

TABLET

Compoziție:

LORAZEPAM 0.5MG

Calea de administrare:

SUBLINGUAL

Unități în pachet:

100/500

Tip de prescriptie medicala:

Targeted (CDSA IV)

Zonă Terapeutică:

BENZODIAZEPINES

Rezumat produs:

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

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2013-08-14

Caracteristicilor produsului

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