Pays: Canada
Langue: français
Source: Health Canada
Chlorhydrate de chlordiazépoxide
AA PHARMA INC
N05BA02
CHLORDIAZEPOXIDE
5MG
Capsule
Chlorhydrate de chlordiazépoxide 5MG
Orale
100
Ciblés (LRCDAS IV)
BENZODIAZEPINES
Numéro de groupe d'ingrédients actifs (GIA) :0100613003; AHFS:
APPROUVÉ
2012-07-04
_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.......................................... Lire le document complet