DORIBAX POWDER FOR SOLUTION

Country: Kanada

Lingwa: Ingliż

Sors: Health Canada

Ingredjent attiv:

DORIPENEM (DORIPENEM MONOHYDRATE)

Disponibbli minn:

JANSSEN INC

Kodiċi ATC:

J01DH04

INN (Isem Internazzjonali):

DORIPENEM

Dożaġġ:

500MG

Għamla farmaċewtika:

POWDER FOR SOLUTION

Kompożizzjoni:

DORIPENEM (DORIPENEM MONOHYDRATE) 500MG

Rotta amministrattiva:

INTRAVENOUS

Unitajiet fil-pakkett:

500ML

Tip ta 'preskrizzjoni:

Prescription

Żona terapewtika:

CARBAPENEMS

Sommarju tal-prodott:

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

L-istatus ta 'awtorizzazzjoni:

CANCELLED POST MARKET

Data ta 'l-awtorizzazzjoni:

2013-07-03

Karatteristiċi tal-prodott

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