AVELOX I.V. SOLUTION

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

MOXIFLOXACIN (MOXIFLOXACIN HYDROCHLORIDE)

Disponible depuis:

BAYER INC

Code ATC:

J01MA14

DCI (Dénomination commune internationale):

MOXIFLOXACIN

Dosage:

400MG

forme pharmaceutique:

SOLUTION

Composition:

MOXIFLOXACIN (MOXIFLOXACIN HYDROCHLORIDE) 400MG

Mode d'administration:

INTRAVENOUS

Unités en paquet:

250 ML

Type d'ordonnance:

Prescription

Domaine thérapeutique:

QUINOLONES

Descriptif du produit:

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

Statut de autorisation:

CANCELLED POST MARKET

Date de l'autorisation:

2020-06-29

Résumé des caractéristiques du produit

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