MOXIFLOXACIN TABLET

Држава: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

MOXIFLOXACIN (MOXIFLOXACIN HYDROCHLORIDE)

Доступно од:

PRO DOC LIMITEE

АТЦ код:

J01MA14

INN (Међународно име):

MOXIFLOXACIN

Дозирање:

400MG

Фармацеутски облик:

TABLET

Састав:

MOXIFLOXACIN (MOXIFLOXACIN HYDROCHLORIDE) 400MG

Пут администрације:

ORAL

Јединице у пакету:

30

Тип рецептора:

Prescription

Терапеутска област:

QUINOLONES

Резиме производа:

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

Статус ауторизације:

APPROVED

Датум одобрења:

2017-04-12

Карактеристике производа

Page 1 of 67
PRODUCT MONOGRAPH
PR
MOXIFLOXACIN
Moxifloxacin Tablets
400 mg Moxifloxacin (as moxifloxacin hydrochloride)
House Standard
Antibacterial Agent
PRO DOC LTÉE
2925 boul. Industriel
Laval, Québec
H7L 3W9
Date of Revision:
February 19, 2021.
SUBMISSION CONTROL NO:
248826
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
.............................................................................
20
OVERDOSAGE
...............................................................................................................
22
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 22
STORAGE AND STABILITY
.........................................................................................
29
SPECIAL HANDLING INSTRUCTIONS
......................................................................
29
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 30
PART II: SCIENTIFIC INFORMATION
...............................................................................
31
PHARMACEUTICAL INFORMATION
.........................................................................
31
CLINICAL TRIALS
........................................................................................