CLARITIN RAPID DISSOLVE TABLET (ORALLY DISINTEGRATING)

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)
30-04-2020

有效成分:

LORATADINE

可用日期:

BAYER INC

ATC代码:

R06AX13

INN(国际名称):

LORATADINE

剂量:

10MG

药物剂型:

TABLET (ORALLY DISINTEGRATING)

组成:

LORATADINE 10MG

给药途径:

ORAL

每包单位数:

8/10/30

处方类型:

OTC

治疗领域:

SECOND GENERATION ANTIHISTAMINES

產品總結:

Active ingredient group (AIG) number: 0120416001; AHFS:

授权状态:

APPROVED

授权日期:

1998-04-06

产品特点

                                _CLARITIN ALLERGY, CLARITIN RAPID DISSOLVE, CLARITIN KIDS RAPID
DISSOLVE & CLARITIN KIDS_
_Page 1 of 40_
PRODUCT MONOGRAPH
CLARITIN
®
ALLERGY
Loratadine Tablets USP 10 mg
CLARITIN
®
RAPID DISSOLVE™
Loratadine Orally Disintegrating Tablets USP 10 mg
Loratadine Orally Disintegrating Tablets USP 5 mg
CLARITIN
®
KIDS RAPID DISSOLVE™
Loratadine Orally Disintegrating Tablets USP 5 mg
CLARITIN KIDS
®
Loratadine Oral Solution USP 1 mg/mL
Histamine H
1
receptor antagonist
Bayer Inc.
2920 Matheson Blvd. E
Mississauga, ON
L4W 5R6
Date of Revision:
April 30
th
, 2020
Submission Control No: 228699
® TM see www.bayer.ca/tm-mc
_CLARITIN ALLERGY, CLARITIN RAPID DISSOLVE, CLARITIN KIDS RAPID
DISSOLVE & CLARITIN KIDS_
_Page 2 of 40_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION.....................................................3
SUMMARY PRODUCT INFORMATION
...............................................................................3
INDICATIONS AND CLINICAL
USE.....................................................................................3
CONTRAINDICATIONS
..........................................................................................................4
WARNINGS AND
PRECAUTIONS.........................................................................................4
ADVERSE
REACTIONS...........................................................................................................5
DRUG INTERACTIONS
...........................................................................................................9
DOSAGE AND
ADMINISTRATION.......................................................................................9
OVERDOSAGE
.......................................................................................................................11
ACTION AND CLINICAL PHARMACOLOGY
...................................................................11
STORAGE AND
STABILITY.................................................................................................15
SPECIAL HANDL
                                
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产品特点 产品特点 法文 30-04-2020