AERIUS SYRUP

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

DESLORATADINE

제공처:

BAYER INC

ATC 코드:

R06AX27

INN (International Name):

DESLORATADINE

복용량:

0.5MG

약제 형태:

SYRUP

구성:

DESLORATADINE 0.5MG

관리 경로:

ORAL

패키지 단위:

100

처방전 유형:

OTC

치료 영역:

SECOND GENERATION ANTIHISTAMINES

제품 요약:

Active ingredient group (AIG) number: 0143961002; AHFS:

승인 상태:

APPROVED

승인 날짜:

2014-12-18

제품 특성 요약

_AERIUS Tablets / AERIUS Syrup / AERIUS KIDS Syrup _
_Page 1 of 37 _
PRODUCT MONOGRAPH
AERIUS
®
DESLORATADINE TABLET 5 MG
DESLORATADINE SYRUP 0.5 MG/ML
AERIUS KIDS
®
DESLORATADINE SYRUP 0.5 MG/ML
HISTAMINE H
1
-RECEPTOR ANTAGONIST
Bayer Inc., Consumer Care
2920 Matheson Blvd. E
Mississauga, ON
L4W 5R6
Date of Preparation:
December 4, 2014
Submission Control No: 179382, 179387
_AERIUS Tablets / AERIUS Syrup / AERIUS KIDS Syrup _
_Page 2 of 37 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................3
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
....................................................................................................5
DRUG INTERACTIONS
....................................................................................................7
DOSAGE AND ADMINISTRATION
................................................................................7
OVERDOSAGE
..................................................................................................................8
ACTION AND CLINICAL PHARMACOLOGY
..............................................................8
STORAGE AND STABILITY
..........................................................................................11
SPECIAL HANDLING INSTRUCTIONS
.......................................................................11
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................11
PART II: SCIENTIFIC INFORMATION
...............................................................................13
PHARMACEUTICAL INFORMATION
......................