CLARITIN KIDS RAPID DISSOLVE TABLET (ORALLY DISINTEGRATING)

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

LORATADINE

Sẵn có từ:

BAYER INC

Mã ATC:

R06AX13

INN (Tên quốc tế):

LORATADINE

Liều dùng:

5MG

Dạng dược phẩm:

TABLET (ORALLY DISINTEGRATING)

Thành phần:

LORATADINE 5MG

Tuyến hành chính:

ORAL

Các đơn vị trong gói:

15G/50G

Loại thuốc theo toa:

OTC

Khu trị liệu:

SECOND GENERATION ANTIHISTAMINES

Tóm tắt sản phẩm:

Active ingredient group (AIG) number: 0120416003; AHFS:

Tình trạng ủy quyền:

APPROVED

Ngày ủy quyền:

2020-11-27

Đặc tính sản phẩm

_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