HYDROXYZINE HYDROCHLORIDE INJECTION USP LIQUID

国: カナダ

言語: 英語

ソース: Health Canada

即購入

製品の特徴 製品の特徴 (SPC)
11-05-2022

有効成分:

HYDROXYZINE HYDROCHLORIDE

から入手可能:

SANDOZ CANADA INCORPORATED

ATCコード:

N05BB01

INN(国際名):

HYDROXYZINE

投薬量:

50MG

医薬品形態:

LIQUID

構図:

HYDROXYZINE HYDROCHLORIDE 50MG

投与経路:

INTRAMUSCULAR

パッケージ内のユニット:

10X1ML/1X10ML

処方タイプ:

Prescription

治療領域:

MISCELLANEOUS ANXIOLYTICS SEDATIVES AND HYPNOTICS

製品概要:

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

認証ステータス:

APPROVED

承認日:

2005-08-12

製品の特徴

                                _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

                                
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