DORIBAX POWDER FOR SOLUTION

Država: Kanada

Jezik: engleski

Izvor: Health Canada

Aktivni sastojci:

DORIPENEM (DORIPENEM MONOHYDRATE)

Dostupno od:

JANSSEN INC

ATC koda:

J01DH04

INN (International ime):

DORIPENEM

Doziranje:

500MG

Farmaceutski oblik:

POWDER FOR SOLUTION

Sastav:

DORIPENEM (DORIPENEM MONOHYDRATE) 500MG

Administracija rute:

INTRAVENOUS

Jedinice u paketu:

500ML

Tip recepta:

Prescription

Područje terapije:

CARBAPENEMS

Proizvod sažetak:

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

Status autorizacije:

CANCELLED POST MARKET

Datum autorizacije:

2013-07-03

Svojstava lijeka

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