AERIUS SYRUP

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)
04-12-2014

有效成分:

DESLORATADINE

可用日期:

BAYER INC

ATC代码:

R06AX27

INN(国际名称):

DESLORATADINE

剂量:

0.5MG

药物剂型:

SYRUP

组成:

DESLORATADINE 0.5MG

给药途径:

ORAL

每包单位数:

100

处方类型:

OTC

治疗领域:

SECOND GENERATION ANTIHISTAMINES

產品總結:

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

授权状态:

APPROVED

授权日期:

2014-12-18

产品特点

                                _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
......................
                                
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