AVELOX I.V. SOLUTION

국가: 캐나다

언어: 영어

출처: Health Canada

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Download 제품 특성 요약 (SPC)
18-02-2020

유효 성분:

MOXIFLOXACIN (MOXIFLOXACIN HYDROCHLORIDE)

제공처:

BAYER INC

ATC 코드:

J01MA14

INN (International Name):

MOXIFLOXACIN

복용량:

400MG

약제 형태:

SOLUTION

구성:

MOXIFLOXACIN (MOXIFLOXACIN HYDROCHLORIDE) 400MG

관리 경로:

INTRAVENOUS

패키지 단위:

250 ML

처방전 유형:

Prescription

치료 영역:

QUINOLONES

제품 요약:

Active ingredient group (AIG) number: 0142242002; AHFS:

승인 상태:

CANCELLED POST MARKET

승인 날짜:

2020-06-29

제품 특성 요약

                                _ _
_AVELOX Product Monograph Page 1 of 73 _
PRODUCT MONOGRAPH
PR
AVELOX

Moxifloxacin tablets
400 mg
(as moxifloxacin hydrochloride)
PR
AVELOX
 I.V.
Moxifloxacin injection
400 mg/250 mL (1.6 mg/mL)
(as moxifloxacin hydrochloride)
Antibacterial Agent
Manufactured by:
Bayer Inc.
2920 Matheson Boulevard East
Mississauga, Ontario
L4W 5R6
www.bayer.ca
Date of Revision:
February 18, 2020
Submission Control No: 233350

2020, Bayer Inc.
® TM see www.bayer.ca/tm-mc
_ _
_AVELOX Product Monograph Page 2 of 73 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
..........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................6
WARNINGS AND PRECAUTIONS
..................................................................................6
ADVERSE REACTIONS
..................................................................................................14
DRUG INTERACTIONS
..................................................................................................19
DOSAGE AND ADMINISTRATION
..............................................................................21
OVERDOSAGE
................................................................................................................24
ACTION AND CLINICAL PHARMACOLOGY
............................................................24
STORAGE AND STABILITY
..........................................................................................32
SPECIAL HANDLING INSTRUCTIONS
.......................................................................32
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................33
PART II : SCIENTIFIC INFORMATION
...................................................................
                                
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