DORIBAX POWDER FOR SOLUTION
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
17-06-2013
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Active ingredient:
DORIPENEM (DORIPENEM MONOHYDRATE)
Available from:
JANSSEN INC
ATC code:
J01DH04
INN (International Name):
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
Product summary:
Active ingredient group (AIG) number: 0152649001; AHFS:
Authorization status:
CANCELLED POST MARKET
Authorization date:
2013-07-03
Summary of Product characteristics
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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.
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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
.........................................................................................
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