DOM-MOXIFLOXACIN TABLET

País: Canadà

Idioma: anglès

Font: Health Canada

ingredients actius:

MOXIFLOXACIN (MOXIFLOXACIN HYDROCHLORIDE)

Disponible des:

DOMINION PHARMACAL

Codi ATC:

J01MA14

Designació comuna internacional (DCI):

MOXIFLOXACIN

Dosis:

400MG

formulario farmacéutico:

TABLET

Composición:

MOXIFLOXACIN (MOXIFLOXACIN HYDROCHLORIDE) 400MG

Vía de administración:

ORAL

Unidades en paquete:

10/30/100/500

tipo de receta:

Prescription

Área terapéutica:

QUINOLONES

Resumen del producto:

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

Estat d'Autorització:

CANCELLED PRE MARKET

Data d'autorització:

2019-09-13

Fitxa tècnica

PRODUCT MONOGRAPH
PR
DOM-MOXIFLOXACIN
Moxifloxacin tablets
400 mg
(as moxifloxacin hydrochloride)
ANTIBACTERIAL AGENT
DOMINION PHARMACAL
DATE OF REVISION:
6111 Royalmount Avenue, Suite 100
December 23, 2016
Montréal, Quebec, Canada
H4P 2T4
SUBMISSION CONTROL NO:
120276
_ _
_Dom-MOXIFLOXACIN Product Monograph _
_Page 2 of 67 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................... 3
SUMMARY
PRODUCT
INFORMATION
...................................................................................
3
INDICATIONS
AND
CLINICAL
USE
.........................................................................................
3
CONTRAINDICATIONS
..............................................................................................................
5
WARNINGS
AND
PRECAUTIONS
.............................................................................................
6
ADVERSE
REACTIONS
............................................................................................................
14
DRUG
INTERACTIONS
.............................................................................................................
18
DOSAGE
AND
ADMINISTRATION
.........................................................................................
21
OVERDOSAGE
...........................................................................................................................
22
ACTION
AND
CLINICAL
PHARMACOLOGY
.......................................................................
23
STORAGE
AND
STABILITY
.....................................................................................................
31
SPECIAL
HANDLING
INSTRUCTIONS
..................................................................................
31
DOSAGE
FORMS,
COMPOSITION
AND
PACKAGING ........................................................ 32
PART II: SCIENTIFIC INFORMATION
..................................................................................
33
PHARMACEUTICAL
INFORMATIO