DESLORATADINE TABLETS

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

DESLORATADINE

제공처:

APOTEX INC

ATC 코드:

R06AX27

INN (International Name):

DESLORATADINE

복용량:

5MG

약제 형태:

TABLET

구성:

DESLORATADINE 5MG

관리 경로:

ORAL

패키지 단위:

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

처방전 유형:

OTC

치료 영역:

SECOND GENERATION ANTIHISTAMINES

제품 요약:

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

승인 상태:

APPROVED

승인 날짜:

2010-02-05

제품 특성 요약

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
.............................