AURO-MOXIFLOXACIN TABLET
국가: 캐나다
언어: 영어
출처: Health Canada
제품 특성 요약
(SPC)
10-03-2020
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유효 성분:
MOXIFLOXACIN (MOXIFLOXACIN HYDROCHLORIDE)
제공처:
AURO PHARMA INC
ATC 코드:
J01MA14
INN (International Name):
MOXIFLOXACIN
복용량:
400MG
약제 형태:
TABLET
구성:
MOXIFLOXACIN (MOXIFLOXACIN HYDROCHLORIDE) 400MG
관리 경로:
ORAL
패키지 단위:
30/100/1000
처방전 유형:
Prescription
치료 영역:
QUINOLONES
제품 요약:
Active ingredient group (AIG) number: 0142242001; AHFS:
승인 상태:
APPROVED
승인 날짜:
2015-11-04
제품 특성 요약
Page 1 of 66
PRODUCT MONOGRAPH
PR
AURO-MOXIFLOXACIN
Moxifloxacin Tablets
400 mg Moxifloxacin (as moxifloxacin hydrochloride)
House Standard
Antibacterial Agent
AURO PHARMA INC.
3700 Steeles Avenue West, Suite # 402
Woodbridge, Ontario, L4L 8K8
CANADA
Date of Revision:
March 10, 2020
SUBMISSION CONTROL NO:
236492
Page 2 of 66
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
.............................................................................
20
OVERDOSAGE
...............................................................................................................
21
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 22
STORAGE AND STABILITY
.........................................................................................
29
SPECIAL HANDLING INSTRUCTIONS
......................................................................
29
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 29
PART II: SCIENTIFIC INFORMATION
...............................................................................
30
PHARMACEUTICAL INFORMATION
.........................................................................
30
CLINICAL TRIALS
.......................................................
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