TEVA-MOXIFLOXACIN TABLET

Страна: Канада

Язык: английский

Источник: Health Canada

Активный ингредиент:

MOXIFLOXACIN (MOXIFLOXACIN HYDROCHLORIDE)

Доступна с:

TEVA CANADA LIMITED

код АТС:

J01MA14

ИНН (Международная Имя):

MOXIFLOXACIN

дозировка:

400MG

Фармацевтическая форма:

TABLET

состав:

MOXIFLOXACIN (MOXIFLOXACIN HYDROCHLORIDE) 400MG

Администрация маршрут:

ORAL

Штук в упаковке:

30/100

Тип рецепта:

Prescription

Терапевтические области:

QUINOLONES

Обзор продуктов:

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

Статус Авторизация:

APPROVED

Дата Авторизация:

2015-11-04

Характеристики продукта

1
PRODUCT MONOGRAPH
PR
TEVA-MOXIFLOXACIN
Moxifloxacin tablets
400 mg moxifloxacin (as moxifloxacin hydrochloride)
Antibacterial Agent
Teva Canada Limited
Date of Revision:
30 Novopharm Court
Dec 02, 2020
Toronto, Ontario
M1B 2K9
Submission Control No: 241009
2
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
.........................................................................................................
14
DRUG INTERACTIONS
.........................................................................................................
18
DOSAGE AND ADMINISTRATION
.....................................................................................
20
OVERDOSAGE
.......................................................................................................................
22
ACTION AND CLINICAL PHARMACOLOGY
................................................................... 23
STORAGE AND STABILITY
.................................................................................................
29
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 29
PART II: SCIENTIFIC INFORMATION
...............................................................................
31
PHARMACEUTICAL INFORMATION
.................................................................................
31
CLINICAL TRIALS
.................................................................................................................
32
DETAILED PHA