MOXIFLOXACIN TABLET

Država: Kanada

Jezik: engleski

Izvor: Health Canada

Aktivni sastojci:

MOXIFLOXACIN (MOXIFLOXACIN HYDROCHLORIDE)

Dostupno od:

SANIS HEALTH INC

ATC koda:

J01MA14

INN (International ime):

MOXIFLOXACIN

Doziranje:

400MG

Farmaceutski oblik:

TABLET

Sastav:

MOXIFLOXACIN (MOXIFLOXACIN HYDROCHLORIDE) 400MG

Administracija rute:

ORAL

Jedinice u paketu:

15G/50G

Tip recepta:

Prescription

Područje terapije:

QUINOLONES

Proizvod sažetak:

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

Status autorizacije:

APPROVED

Datum autorizacije:

2021-09-23

Svojstava lijeka

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..........................