DORIBAX POWDER FOR SOLUTION
Land: Kanada
Språk: engelska
Källa: Health Canada
Produktens egenskaper
(SPC)
17-06-2013
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Aktiva substanser:
DORIPENEM (DORIPENEM MONOHYDRATE)
Tillgänglig från:
JANSSEN INC
ATC-kod:
J01DH04
INN (International namn):
DORIPENEM
Dos:
500MG
Läkemedelsform:
POWDER FOR SOLUTION
Sammansättning:
DORIPENEM (DORIPENEM MONOHYDRATE) 500MG
Administreringssätt:
INTRAVENOUS
Enheter i paketet:
500ML
Receptbelagda typ:
Prescription
Terapiområde:
CARBAPENEMS
Produktsammanfattning:
Active ingredient group (AIG) number: 0152649001; AHFS:
Bemyndigande status:
CANCELLED POST MARKET
Tillstånd datum:
2013-07-03
Produktens egenskaper
_DORIBAX 163140 APM.doc _
_ _
_Page 1 of 47 _
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 _
_ _
_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
.........................................................................................
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