DORIBAX POWDER FOR SOLUTION

Nchi: Kanada

Lugha: Kiingereza

Chanzo: Health Canada

Viambatanisho vya kazi:

DORIPENEM (DORIPENEM MONOHYDRATE)

Inapatikana kutoka:

JANSSEN INC

ATC kanuni:

J01DH04

INN (Jina la Kimataifa):

DORIPENEM

Kipimo:

500MG

Dawa fomu:

POWDER FOR SOLUTION

Tungo:

DORIPENEM (DORIPENEM MONOHYDRATE) 500MG

Njia ya uendeshaji:

INTRAVENOUS

Vitengo katika mfuko:

500ML

Dawa ya aina:

Prescription

Eneo la matibabu:

CARBAPENEMS

Bidhaa muhtasari:

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

Idhini hali ya:

CANCELLED POST MARKET

Idhini ya tarehe:

2013-07-03

Tabia za bidhaa

_DORIBAX 163140 APM.doc _
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_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
.........................................................................................