LEVAQUIN TABLET

Pajjiż: Kanada

Lingwa: Ingliż

Sors: Health Canada

Ingredjent attiv:

LEVOFLOXACIN

Disponibbli minn:

JANSSEN INC

Kodiċi ATC:

J01MA12

INN (Isem Internazzjonali):

LEVOFLOXACIN

Dożaġġ:

250MG

Għamla farmaċewtika:

TABLET

Kompożizzjoni:

LEVOFLOXACIN 250MG

Rotta amministrattiva:

ORAL

Unitajiet fil-pakkett:

50

Tip ta 'preskrizzjoni:

Prescription

Żona terapewtika:

QUINOLONES

Sommarju tal-prodott:

Active ingredient group (AIG) number: 0131663003; AHFS:

L-istatus ta 'awtorizzazzjoni:

CANCELLED POST MARKET

Data ta 'l-awtorizzazzjoni:

2014-10-27

Karatteristiċi tal-prodott

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PRODUCT MONOGRAPH
PR
LEVAQUIN
®
levofloxacin
250 mg, 500 mg and 750 mg Tablets
Antibacterial Agent
Janssen Inc.
19 Green Belt Drive
Toronto, Ontario
M3C 1L9
www.janssen.ca
Date of Revision:
August 13, 2014
Submission Control No: 175523
All trademark rights used under license.
© 2014 Janssen Inc.
_175523.doc _
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_Page 2 of 66 _
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
.........................................................................................................
10
DRUG INTERACTIONS
.........................................................................................................
14
DOSAGE AND ADMINISTRATION
.....................................................................................
16
OVERDOSAGE
.......................................................................................................................
19
ACTION AND CLINICAL PHARMACOLOGY
................................................................... 19
STORAGE AND STABILITY
.................................................................................................
23
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 23
PART II: SCIENTIFIC INFORMATION
..............................................................................
25
PHARMACEUTICAL INFORMATION
.................................................................................
25
CLINICAL TRIALS
........................