PMS-MOXIFLOXACIN TABLET

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

MOXIFLOXACIN (MOXIFLOXACIN HYDROCHLORIDE)

Disponible depuis:

PHARMASCIENCE INC

Code ATC:

J01MA14

DCI (Dénomination commune internationale):

MOXIFLOXACIN

Dosage:

400MG

forme pharmaceutique:

TABLET

Composition:

MOXIFLOXACIN (MOXIFLOXACIN HYDROCHLORIDE) 400MG

Mode d'administration:

ORAL

Unités en paquet:

100

Type d'ordonnance:

Prescription

Domaine thérapeutique:

QUINOLONES

Descriptif du produit:

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

Statut de autorisation:

APPROVED

Date de l'autorisation:

2015-12-21

Résumé des caractéristiques du produit

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_pms-MOXIFLOXACIN Product Monograph _
_Page 1 of 69 _
PRODUCT MONOGRAPH
PR
PMS-MOXIFLOXACIN
Moxifloxacin Tablets
400 mg
(as moxifloxacin hydrochloride)
ANTIBACTERIAL AGENT
PHARMASCIENCE INC.
DATE OF REVISION:
6111 Royalmount Avenue, Suite 100
May 9, 2019
Montréal, Canada
H4P 2T4
www.pharmascience.com
SUBMISSION CONTROL NO: 225692
_ _
_pms-MOXIFLOXACIN Product Monograph _
_Page 2 of 69 _
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
.........................................................................................................
15
DRUG
INTERACTIONS
.........................................................................................................
19
DOSAGE
AND
ADMINISTRATION
.....................................................................................
21
OVERDOSAGE
.......................................................................................................................
22
ACTION
AND
CLINICAL
PHARMACOLOGY
....................................................................
23
STORAGE
AND
STABILITY
.................................................................................................
31
SPECIAL
HANDLING
INSTRUCTIONS
...............................................................................
31
DOSAGE
FORMS,
COMPOSITION
AND
PACKAGING ..................................................... 31
PART II: SCIENTIFIC INFORMATION
..............................................................................
32
PHARMACEU