CHLORDIAZEPOXIDE Capsule

Țară: Canada

Limbă: franceză

Sursă: Health Canada

Ingredient activ:

Chlorhydrate de chlordiazépoxide

Disponibil de la:

AA PHARMA INC

Codul ATC:

N05BA02

INN (nume internaţional):

CHLORDIAZEPOXIDE

Dozare:

25MG

Forma farmaceutică:

Capsule

Compoziție:

Chlorhydrate de chlordiazépoxide 25MG

Calea de administrare:

Orale

Unități în pachet:

100/500

Tip de prescriptie medicala:

Ciblés (LRCDAS IV)

Zonă Terapeutică:

BENZODIAZEPINES

Rezumat produs:

Numéro de groupe d'ingrédients actifs (GIA) :0100613002; AHFS:

Statutul autorizaţiei:

APPROUVÉ

Data de autorizare:

2012-07-04

Caracteristicilor produsului

_CHLORDIAZEPOXIDE (Chlordiazepoxide hydrochloride) _
_ _
_Page 1 of 26_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
CHLORDIAZEPOXIDE
Chlordiazepoxide
hydrochloride
Capsule, 5 mg, 10 mg and 25 mg, Oral
USP
ATC Code: N05BA02
Anxiolytic
AA PHARMA INC.
Vaughan, Ontario
L4K 4N7
www.aapharma.ca
Date of Initial Authorization:
December 31, 1981
Date of Revision:
August 08, 2022
Submission Control Number: 253151
_CHLORDIAZEPOXIDE (Chlordiazepoxide hydrochloride) _
_ _
_Page 2 of 26_
RECENT MAJOR LABEL CHANGES
1 Indications, 1.2 Geriatrics
12/2021
2 Contraindications
12/2021
3 Serious Warnings and Precautions Box
12/2021
4 Dosage and Administration, 4.1 Dosing considerations
12/2021
7 Warnings and Precautions
12/2021
7 Warnings and Precautions, 7.1.1 Pregnant Women
12/2021
7 Warnings and Precautions, 7.1.2 Breast-feeding
12/2021
7 Warnings and Precautions, 7.1.4 Geriatrics
12/2021
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
................................................................................................................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
..............................................................5
4
DOSAGE AND
ADMINISTRATION..........................................