국가: 캐나다
언어: 영어
출처: Health Canada
HYDROXYZINE HYDROCHLORIDE
SANDOZ CANADA INCORPORATED
N05BB01
HYDROXYZINE
50MG
LIQUID
HYDROXYZINE HYDROCHLORIDE 50MG
INTRAMUSCULAR
10X1ML/1X10ML
Prescription
MISCELLANEOUS ANXIOLYTICS SEDATIVES AND HYPNOTICS
Active ingredient group (AIG) number: 0106172004; AHFS:
APPROVED
2005-08-12
_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 전체 문서 읽기