DORIBAX POWDER FOR SOLUTION

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

DORIPENEM (DORIPENEM MONOHYDRATE)

Pieejams no:

JANSSEN INC

ATĶ kods:

J01DH04

SNN (starptautisko nepatentēto nosaukumu):

DORIPENEM

Deva:

500MG

Zāļu forma:

POWDER FOR SOLUTION

Kompozīcija:

DORIPENEM (DORIPENEM MONOHYDRATE) 500MG

Ievadīšanas:

INTRAVENOUS

Vienības iepakojumā:

500ML

Receptes veids:

Prescription

Ārstniecības joma:

CARBAPENEMS

Produktu pārskats:

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

Autorizācija statuss:

CANCELLED POST MARKET

Autorizācija datums:

2013-07-03

Produkta apraksts

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