AVELOX TABLET

Krajina: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktívna zložka:

MOXIFLOXACIN (MOXIFLOXACIN HYDROCHLORIDE)

Dostupné z:

BAYER INC

ATC kód:

J01MA14

INN (Medzinárodný Name):

MOXIFLOXACIN

Dávkovanie:

400MG

Forma lieku:

TABLET

Zloženie:

MOXIFLOXACIN (MOXIFLOXACIN HYDROCHLORIDE) 400MG

Spôsob podávania:

ORAL

Počet v balení:

30

Typ predpisu:

Prescription

Terapeutické oblasti:

QUINOLONES

Prehľad produktov:

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

Stav Autorizácia:

CANCELLED POST MARKET

Dátum Autorizácia:

2019-07-04

Súhrn charakteristických

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