M-MOXIFLOXACIN TABLET

Страна: Канада

Език: английски

Източник: Health Canada

Активна съставка:

MOXIFLOXACIN (MOXIFLOXACIN HYDROCHLORIDE)

Предлага се от:

MANTRA PHARMA INC

АТС код:

J01MA14

INN (Международно Name):

MOXIFLOXACIN

дозиране:

400MG

Лекарствена форма:

TABLET

Композиция:

MOXIFLOXACIN (MOXIFLOXACIN HYDROCHLORIDE) 400MG

Начин на приложение:

ORAL

Броя в опаковка:

100

Вид предписание :

Prescription

Терапевтична област:

QUINOLONES

Каталог на резюме:

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

Статус Оторизация:

APPROVED

Дата Оторизация:

2018-02-05

Данни за продукта

M-Moxifloxacin Product Monograph _Page 1 of 72_
PRODUCT MONOGRAPH
PR
M-MOXIFLOXACIN
Moxifloxacin tablets
400 mg
(as moxifloxacin hydrochloride)
Manufacturer’s Standard
Antibacterial Agent
Mantra Pharma Inc.
9150 Leduc boulevard, suite 201
Brossard, Quebec
Canada J4Y 0E3
Submission Control No.: 266794
Date of Revision:
SEP
21, 2022
M-Moxifloxacin Product Monograph _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
.....................................................................................
21
OVERDOSAGE
........................................................................................................................
23
ACTION AND CLINICAL PHARMACOLOGY
....................................................................
24
STORAGE AND STABILITY
.................................................................................................
30
SPECIAL HANDLING INSTRUCTIONS
...............................................................................
31
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 31
PART II : SCIENTIFIC INFORMATION
.................................................................................
32
PHARMACEUTICAL