TEVA-CIPROFLOXACIN TABLET

Страна: Канада

Език: английски

Източник: Health Canada

Активна съставка:

CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE)

Предлага се от:

TEVA CANADA LIMITED

АТС код:

J01MA02

INN (Международно Name):

CIPROFLOXACIN

дозиране:

750MG

Лекарствена форма:

TABLET

Композиция:

CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) 750MG

Начин на приложение:

ORAL

Броя в опаковка:

100/500/1000

Вид предписание :

Prescription

Терапевтична област:

QUINOLONES

Каталог на резюме:

Active ingredient group (AIG) number: 0123207002; AHFS:

Статус Оторизация:

CANCELLED POST MARKET

Дата Оторизация:

2018-06-19

Данни за продукта

1
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
TEVA-CIPROFLOXACIN
(Ciprofloxacin Hydrochloride Tablets)
USP
250 mg, 500 mg, 750 mg
Antibacterial Agent
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9
www.tevacanada.com
Date of revision:
April 5, 2018
CONTROL NO.: 214056
2
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
................................................................ 3
SUMMARY PRODUCT INFORMATION
...............................................................................
3
INDICATIONS AND CLINICAL USE
....................................................................................
3
CONTRAINDICATIONS
..........................................................................................................
6
WARNINGS AND PRECAUTIONS
........................................................................................
7
ADVERSE REACTIONS
........................................................................................................
12
DRUG INTERACTIONS
........................................................................................................
14
DOSAGE AND ADMINISTRATION
....................................................................................
20
OVERDOSAGE
.......................................................................................................................
22
ACTION AND CLINICAL PHARMACOLOGY
................................................................... 22
STORAGE AND STABILITY
................................................................................................
24
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 24
PART II: SCIENTIFIC INFORMATION
......................................................................................
26
PHARMACEUTICAL INFORMATION
................................................................................
26
CLINICAL TRIALS
..............................................................................