MOXIFLOXACIN TABLET

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

MOXIFLOXACIN (MOXIFLOXACIN HYDROCHLORIDE)

Commercializzato da:

SANIS HEALTH INC

Codice ATC:

J01MA14

INN (Nome Internazionale):

MOXIFLOXACIN

Dosaggio:

400MG

Forma farmaceutica:

TABLET

Composizione:

MOXIFLOXACIN (MOXIFLOXACIN HYDROCHLORIDE) 400MG

Via di somministrazione:

ORAL

Confezione:

15G/50G

Tipo di ricetta:

Prescription

Area terapeutica:

QUINOLONES

Dettagli prodotto:

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

Stato dell'autorizzazione:

APPROVED

Data dell'autorizzazione:

2021-09-23

Scheda tecnica

Page 1 of 66
PRODUCT MONOGRAPH
PR
MOXIFLOXACIN
Moxifloxacin Tablets
400 mg Moxifloxacin
(as moxifloxacin
hydrochloride)
House Standard
Antibacterial Agent
SANIS HEALTH INC.
1 President’s Choice Circle
Brampton, Ontario
L6Y 5S5
Date of Revision:
September 21, 2021
SUBMISSION CONTROL NO:
249928
Page 2 of 66
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
.........................................................................20
OVERDOSAGE
.........................................................................................................21
ACTION AND CLINICAL
PHARMACOLOGY.........................................................22
STORAGE AND STABILITY
....................................................................................29
SPECIAL HANDLING INSTRUCTIONS
...................................................................29
DOSAGE FORMS, COMPOSITION AND PACKAGING
..........................................29
PART II: SCIENTIFIC INFORMATION
..........................................................................
30
PHARMACEUTICAL INFORMATION
.....................................................................30
CLINICAL TRIALS
...................................................................................................31
DETAILED
PHARMACOLOGY..........................