MED-MOXIFLOXACIN TABLET
País: Canadà
Idioma: anglès
Font: Health Canada
Fitxa tècnica
(SPC)
23-03-2022
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ingredients actius:
MOXIFLOXACIN (MOXIFLOXACIN HYDROCHLORIDE)
Disponible des:
GENERIC MEDICAL PARTNERS INC
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:
30
tipo de receta:
Prescription
Área terapéutica:
QUINOLONES
Resumen del producto:
Active ingredient group (AIG) number: 0142242001; AHFS:
Estat d'Autorització:
APPROVED
Data d'autorització:
2016-12-12
Fitxa tècnica
_Page 1 of 72_
PRODUCT MONOGRAPH
PR
MED-MOXIFLOXACIN
Moxifloxacin tablets
400 mg
(as moxifloxacin
hydrochloride)
Manufacturer’s Standard
Antibacterial Agent
Generic Medical Partners Inc.
1500 Don Mills Road, Suite 711
Toronto, Ontario
M3B 3K4
Date of Revision:
March 23, 2022
Submission
Control No: 255995
_Page 2 of 72_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.................................................... 3
SUMMARY PRODUCT
INFORMATION...........................................................................
3
INDICATIONS AND CLINICAL USE
................................................................................
3
CONTRAINDICATIONS
....................................................................................................
5
WARNINGS AND
PRECAUTIONS....................................................................................
5
ADVERSE REACTIONS
...................................................................................................15
DRUG INTERACTIONS
....................................................................................................19
DOSAGE AND ADMINISTRATION
.................................................................................22
OVERDOSAGE
.................................................................................................................24
ACTION AND CLINICAL PHARMACOLOGY
................................................................24
STORAGE AND STABILITY
............................................................................................31
SPECIAL HANDLING
INSTRUCTIONS...........................................................................31
DOSAGE FORMS, COMPOSITION AND PACKAGING
..................................................31
PART II : SCIENTIFIC INFORMATION
........................................................................
33
PHARMACEUTICAL INFORMATION
.............................................................................33
CLINICAL TRIALS
....................................
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