DORIBAX POWDER FOR SOLUTION

Riik: Kanada

keel: inglise

Allikas: Health Canada

Toimeaine:

DORIPENEM (DORIPENEM MONOHYDRATE)

Saadav alates:

JANSSEN INC

ATC kood:

J01DH04

INN (Rahvusvaheline Nimetus):

DORIPENEM

Annus:

500MG

Ravimvorm:

POWDER FOR SOLUTION

Koostis:

DORIPENEM (DORIPENEM MONOHYDRATE) 500MG

Manustamisviis:

INTRAVENOUS

Ühikuid pakis:

500ML

Retsepti tüüp:

Prescription

Terapeutiline ala:

CARBAPENEMS

Toote kokkuvõte:

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

Volitamisolek:

CANCELLED POST MARKET

Loa andmise kuupäev:

2013-07-03

Toote omadused

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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
.........................................................................................