DORIBAX POWDER FOR SOLUTION

Country: Կանադա

language: անգլերեն

source: Health Canada

active_ingredient:

DORIPENEM (DORIPENEM MONOHYDRATE)

MAH:

JANSSEN INC

ATC_code:

J01DH04

INN:

DORIPENEM

dosage:

500MG

pharmaceutical_form:

POWDER FOR SOLUTION

composition:

DORIPENEM (DORIPENEM MONOHYDRATE) 500MG

administration_route:

INTRAVENOUS

units_in_package:

500ML

prescription_type:

Prescription

therapeutic_area:

CARBAPENEMS

leaflet_short:

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

authorization_status:

CANCELLED POST MARKET

authorization_date:

2013-07-03

SPC

_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
.........................................................................................