CLARITIN LIQUID CAPSULES
국가: 캐나다
언어: 영어
출처: Health Canada
제품 특성 요약
(SPC)
10-05-2019
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유효 성분:
LORATADINE
제공처:
BAYER INC
ATC 코드:
R06AX13
INN (국제 이름):
LORATADINE
복용량:
10MG
약제 형태:
CAPSULE
구성:
LORATADINE 10MG
관리 경로:
ORAL
패키지 단위:
24/36/84
처방전 유형:
OTC
치료 영역:
SECOND GENERATION ANTIHISTAMINES
제품 요약:
Active ingredient group (AIG) number: 0120416001; AHFS:
승인 상태:
APPROVED
승인 날짜:
2014-12-05
제품 특성 요약
PRODUCT MONOGRAPH
CLARITIN
® LIQUID CAPSULES LORATADINE CAPSULES, 10 MG
HISTAMINE H
1
RECEPTOR ANTAGONIST
Bayer Inc.
DATE OF PREPARATION:
2920 Matheson Blvd. E
May 10
th
, 2019
Mississauga, ON
L4W 5R6
Control #: 225631
® TM see www.bayer.ca/tm-mc
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_CLARITIN LIQUID CAPSULES _
_Page 2 of 22_
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
......................................................................................................
4
DRUG INTERACTIONS
.......................................................................................................
6
DOSAGE AND ADMINISTRATION
...................................................................................
7
OVERDOSAGE
.....................................................................................................................
7
ACTION AND CLINICAL PHARMACOLOGY
................................................................. 7
STORAGE AND STABILITY
..............................................................................................
8
SPECIAL HANDLING INSTRUCTIONS
............................................................................
8
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................. 9
PART II: SCIENTIFIC INFORMATION
…………………………………………………….
. 10
PHARMACEUTICAL INFORMATION
............................................................................
10
CLINICAL
TRIALS...........................................................
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