CIPROFLOXACIN TABLET

Страна: Канада

Език: английски

Източник: Health Canada

Активна съставка:

CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE)

Предлага се от:

COBALT PHARMACEUTICALS COMPANY

АТС код:

J01MA02

INN (Международно Name):

CIPROFLOXACIN

дозиране:

250MG

Лекарствена форма:

TABLET

Композиция:

CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) 250MG

Начин на приложение:

ORAL

Броя в опаковка:

100

Вид предписание :

Prescription

Терапевтична област:

QUINOLONES

Каталог на резюме:

Active ingredient group (AIG) number: 0123207006; AHFS:

Статус Оторизация:

CANCELLED PRE MARKET

Дата Оторизация:

2017-09-01

Данни за продукта

_ _
Ciprofloxacin_ _
_Page 1 of 46_
PRODUCT MONOGRAPH
_PR_ CIPROFLOXACIN
(Ciprofloxacin Tablets, USP)
Tablets 250 mg, 500 mg, & 750 mg
Ciprofloxacin (as Ciprofloxacin Hydrochloride)
Antibacterial Agent
Manufactured by:
Cobalt Pharmaceuticals Company
6500 Kitimat Road
Mississauga, Ontario
L5N 2B8
Date of Revision:
May 11, 2012
Submission Control No: 155219
_ _
Ciprofloxacin_ _
_Page 2 of 46_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION........................................................ 3
SUMMARY PRODUCT INFORMATION
.......................................................................
3
INDICATIONS AND CLINICAL
USE.............................................................................
3
CONTRAINDICATIONS
..................................................................................................
6
WARNINGS AND
PRECAUTIONS.................................................................................
6
ADVERSE
REACTIONS.................................................................................................
11
DRUG INTERACTIONS
.................................................................................................
14
DOSAGE AND
ADMINISTRATION.............................................................................
16
OVERDOSAGE
...............................................................................................................
19
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 19
STORAGE AND
STABILITY.........................................................................................
22
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 22
PART II: SCIENTIFIC INFORMATION
..............................................................................
23
PHARMACEUTICAL
INFORMATION.........................................................................
23
CLINICAL
TRIALS......................................................................................................