DORIBAX POWDER FOR SOLUTION

Страна: Канада

Език: английски

Източник: Health Canada

Активна съставка:

DORIPENEM (DORIPENEM MONOHYDRATE)

Предлага се от:

JANSSEN INC

АТС код:

J01DH04

INN (Международно Name):

DORIPENEM

дозиране:

500MG

Лекарствена форма:

POWDER FOR SOLUTION

Композиция:

DORIPENEM (DORIPENEM MONOHYDRATE) 500MG

Начин на приложение:

INTRAVENOUS

Броя в опаковка:

500ML

Вид предписание :

Prescription

Терапевтична област:

CARBAPENEMS

Каталог на резюме:

Active ingredient group (AIG) number: 0152649001; AHFS:

Статус Оторизация:

CANCELLED POST MARKET

Дата Оторизация:

2013-07-03

Данни за продукта

_DORIBAX 163140 APM.doc _
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PRODUCT MONOGRAPH
PR
DORIBAX
®
Doripenem for Injection
500 mg/vial doripenem (as doripenem monohydrate)
Antibacterial Agent
ATC code: J01DH04
Janssen Inc.
19 Green Belt Drive
Toronto, Ontario
M3C 1L9
www.janssen.ca
Date of Revision:
June 14, 2013
Submission Control No: 163140
All trademarks used under license.
© 2013 Janssen Inc.
_DORIBAX 163140 APM.doc _
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_Page 2 of 47 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT INFORMATION
..................................................................................................................
3
INDICATIONS AND CLINICAL USE
........................................................................................................................
3
CONTRAINDICATIONS
.............................................................................................................................................
4
WARNINGS AND PRECAUTIONS
............................................................................................................................
4
ADVERSE REACTIONS
.............................................................................................................................................
8
DRUG INTERACTIONS
............................................................................................................................................
12
DOSAGE AND ADMINISTRATION
........................................................................................................................
13
OVERDOSAGE
..........................................................................................................................................................
17
ACTION AND CLINICAL PHARMACOLOGY
......................................................................................................
17
STORAGE AND STABILITY
.........................................................................................