DOM-MOXIFLOXACIN TABLET
국가: 캐나다
언어: 영어
출처: Health Canada
제품 특성 요약
(SPC)
30-12-2016
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유효 성분:
MOXIFLOXACIN (MOXIFLOXACIN HYDROCHLORIDE)
제공처:
DOMINION PHARMACAL
ATC 코드:
J01MA14
INN (International Name):
MOXIFLOXACIN
복용량:
400MG
약제 형태:
TABLET
구성:
MOXIFLOXACIN (MOXIFLOXACIN HYDROCHLORIDE) 400MG
관리 경로:
ORAL
패키지 단위:
10/30/100/500
처방전 유형:
Prescription
치료 영역:
QUINOLONES
제품 요약:
Active ingredient group (AIG) number: 0142242001; AHFS:
승인 상태:
CANCELLED PRE MARKET
승인 날짜:
2019-09-13
제품 특성 요약
PRODUCT MONOGRAPH
PR
DOM-MOXIFLOXACIN
Moxifloxacin tablets
400 mg
(as moxifloxacin hydrochloride)
ANTIBACTERIAL AGENT
DOMINION PHARMACAL
DATE OF REVISION:
6111 Royalmount Avenue, Suite 100
December 23, 2016
Montréal, Quebec, Canada
H4P 2T4
SUBMISSION CONTROL NO:
120276
_ _
_Dom-MOXIFLOXACIN Product Monograph _
_Page 2 of 67 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................... 3
SUMMARY
PRODUCT
INFORMATION
...................................................................................
3
INDICATIONS
AND
CLINICAL
USE
.........................................................................................
3
CONTRAINDICATIONS
..............................................................................................................
5
WARNINGS
AND
PRECAUTIONS
.............................................................................................
6
ADVERSE
REACTIONS
............................................................................................................
14
DRUG
INTERACTIONS
.............................................................................................................
18
DOSAGE
AND
ADMINISTRATION
.........................................................................................
21
OVERDOSAGE
...........................................................................................................................
22
ACTION
AND
CLINICAL
PHARMACOLOGY
.......................................................................
23
STORAGE
AND
STABILITY
.....................................................................................................
31
SPECIAL
HANDLING
INSTRUCTIONS
..................................................................................
31
DOSAGE
FORMS,
COMPOSITION
AND
PACKAGING ........................................................ 32
PART II: SCIENTIFIC INFORMATION
..................................................................................
33
PHARMACEUTICAL
INFORMATIO
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