AURO-MOXIFLOXACIN TABLET

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

MOXIFLOXACIN (MOXIFLOXACIN HYDROCHLORIDE)

Disponibil de la:

AURO PHARMA INC

Codul ATC:

J01MA14

INN (nume internaţional):

MOXIFLOXACIN

Dozare:

400MG

Forma farmaceutică:

TABLET

Compoziție:

MOXIFLOXACIN (MOXIFLOXACIN HYDROCHLORIDE) 400MG

Calea de administrare:

ORAL

Unități în pachet:

30/100/1000

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

QUINOLONES

Rezumat produs:

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

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2015-11-04

Caracteristicilor produsului

Page 1 of 66
PRODUCT MONOGRAPH
PR
AURO-MOXIFLOXACIN
Moxifloxacin Tablets
400 mg Moxifloxacin (as moxifloxacin hydrochloride)
House Standard
Antibacterial Agent
AURO PHARMA INC.
3700 Steeles Avenue West, Suite # 402
Woodbridge, Ontario, L4L 8K8
CANADA
Date of Revision:
March 10, 2020
SUBMISSION CONTROL NO:
236492
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
.......................................................