AVELOX TABLET

Land: Canada

Sprog: engelsk

Kilde: Health Canada

Aktiv bestanddel:

MOXIFLOXACIN (MOXIFLOXACIN HYDROCHLORIDE)

Tilgængelig fra:

BAYER INC

ATC-kode:

J01MA14

INN (International Name):

MOXIFLOXACIN

Dosering:

400MG

Lægemiddelform:

TABLET

Sammensætning:

MOXIFLOXACIN (MOXIFLOXACIN HYDROCHLORIDE) 400MG

Indgivelsesvej:

ORAL

Enheder i pakken:

30

Recept type:

Prescription

Terapeutisk område:

QUINOLONES

Produkt oversigt:

Active ingredient group (AIG) number: 0142242001; AHFS:

Autorisation status:

CANCELLED POST MARKET

Autorisation dato:

2019-07-04

Produktets egenskaber

_ _
_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
...................................................................