DESLORATADINE TABLETS

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

DESLORATADINE

Sẵn có từ:

APOTEX INC

Mã ATC:

R06AX27

INN (Tên quốc tế):

DESLORATADINE

Liều dùng:

5MG

Dạng dược phẩm:

TABLET

Thành phần:

DESLORATADINE 5MG

Tuyến hành chính:

ORAL

Các đơn vị trong gói:

10/12/20/24/30/36/48/50

Loại thuốc theo toa:

OTC

Khu trị liệu:

SECOND GENERATION ANTIHISTAMINES

Tóm tắt sản phẩm:

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

Tình trạng ủy quyền:

APPROVED

Ngày ủy quyền:

2010-02-05

Đặc tính sản phẩm

Page 1 of 35
PRODUCT MONOGRAPH
DESLORATADINE TABLETS 5 MG DESLORATADINE
HISTAMINE H
1
-RECEPTOR ANTAGONIST
APOTEX INC.
DATE OF REVISION:
150 SIGNET DRIVE
OCTOBER 17, 2018
TORONTO, ONTARIO
M9L 1T9
CONTROL NUMBER: 220366
Page 2 of 35
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................ 3
SUMMARY
PRODUCT
INFORMATION
................................................................................
3
INDICATIONS
AND
CLINICAL
USE
......................................................................................
3
CONTRAINDICATIONS
...........................................................................................................
3
WARNINGS
AND
PRECAUTIONS
..........................................................................................
3
ADVERSE
REACTIONS
...........................................................................................................
5
DRUG
INTERACTIONS
............................................................................................................
6
DOSAGE
AND
ADMINISTRATION
........................................................................................
7
OVERDOSAGE
..........................................................................................................................
7
ACTION
AND
CLINICAL
PHARMACOLOGY
.......................................................................
7
STORAGE
AND
STABILITY
..................................................................................................
10
SPECIAL
HANDLING
INSTRUCTIONS
...............................................................................
10
DOSAGE
FORMS,
COMPOSITION
AND
PACKAGING ...................................................... 10
PART II: SCIENTIFIC INFORMATION
...............................................................................
12
PHARMACEUTICAL
INFORMATION
.................................................................................
12
CLINICAL
TRIALS
.............................