AERIUS TABLET

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

DESLORATADINE

제공처:

BAYER INC

ATC 코드:

R06AX27

INN (International Name):

DESLORATADINE

복용량:

5MG

약제 형태:

TABLET

구성:

DESLORATADINE 5MG

관리 경로:

ORAL

패키지 단위:

10/20/30/100

처방전 유형:

OTC

치료 영역:

SECOND GENERATION ANTIHISTAMINES

제품 요약:

Active ingredient group (AIG) number: 0143961001; AHFS:

승인 상태:

APPROVED

승인 날짜:

2014-11-07

제품 특성 요약

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_ Desloratadine Syrup 0.5 mg/mL> _
_Page 1 of 40 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
AERIUS®
Desloratadine
Tablet, 5mg, Oral
USP
AERIUS® KIDS
Desloratadine
Syrup, 0.5 mg/mL Oral
Professed Standard
Histamine H1-Receptor Antagonist
Bayer Inc.
2920 Matheson Blvd. East
Mississauga, ON
L4W 5R6
Date of Revision:
October 11, 2022
Submission Control Number: 263344
®TM see www.bayer.ca/tm-mc
_ _
_ _
_ Desloratadine Syrup 0.5 mg/mL> _
_Page 2 of 40_
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
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..................................................................
4
4 DOSAGE AND ADMINISTRATION
......................................................................................
4
4.1 Dosing
Considerations....................................................................................................
4
4.2 Recommended Dose and Dosage
Adjustment.................................................................
4
4.3 Administration
...............................................................................................................
5
4.4 Mi