HYDROXYZINE HYDROCHLORIDE INJECTION USP LIQUID

国家: 加拿大

语言: 英文

来源: Health Canada

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产品特点 产品特点 (SPC)
11-05-2022

有效成分:

HYDROXYZINE HYDROCHLORIDE

可用日期:

SANDOZ CANADA INCORPORATED

ATC代码:

N05BB01

INN(国际名称):

HYDROXYZINE

剂量:

50MG

药物剂型:

LIQUID

组成:

HYDROXYZINE HYDROCHLORIDE 50MG

给药途径:

INTRAMUSCULAR

每包单位数:

10X1ML/1X10ML

处方类型:

Prescription

治疗领域:

MISCELLANEOUS ANXIOLYTICS SEDATIVES AND HYPNOTICS

產品總結:

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

授权状态:

APPROVED

授权日期:

2005-08-12

产品特点

                                _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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