HYDROXYZINE HYDROCHLORIDE INJECTION USP LIQUID

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

HYDROXYZINE HYDROCHLORIDE

Disponible depuis:

SANDOZ CANADA INCORPORATED

Code ATC:

N05BB01

DCI (Dénomination commune internationale):

HYDROXYZINE

Dosage:

50MG

forme pharmaceutique:

LIQUID

Composition:

HYDROXYZINE HYDROCHLORIDE 50MG

Mode d'administration:

INTRAMUSCULAR

Unités en paquet:

10X1ML/1X10ML

Type d'ordonnance:

Prescription

Domaine thérapeutique:

MISCELLANEOUS ANXIOLYTICS SEDATIVES AND HYPNOTICS

Descriptif du produit:

Active ingredient group (AIG) number: 0106172004; AHFS:

Statut de autorisation:

APPROVED

Date de l'autorisation:

2005-08-12

Résumé des caractéristiques du produit

_Hydroxyzine Hydrochloride Injection USP _
_ _
_Page 1 of 19 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
HYDROXYZINE HYDROCHLORIDE INJECTION USP
Hydroxyzine Hydrochloride
Solution, 50 mg/mL, for Intramuscular administration
USP
Anxiolytic - Sedative
Sandoz Canada Inc.
110 rue de Lauzon
Boucherville, Québec, Canada
J4B 1E6
Date of Initial Authorization:
APR 27, 1987
Date of Revision:
MAY 11, 2022
Submission Control Number: 256978
_Hydroxyzine Hydrochloride Injection USP _
_ _
_Page 2 of 19 _
RECENT MAJOR LABEL CHANGES
2 CONTRAINDICATIONS
05/2022
4 DOSAGE AND ADMINISTRATION, 4.1 Dosing Considerations
05/2022
5 OVERDOSAGE
05/2022
7 WARNINGS AND PRECAUTIONS
05/2022
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
4 DOSAGE AND
ADMINISTRATION................................................................................................5
4.1
Dosing
Considerations...........................................................................................5
4.2
Recommended Dose and Dosage
Adjustment...........................................................5