SANDOZ LEVOFLOXACIN TABLET

Land: Kanada

Sprache: Englisch

Quelle: Health Canada

Wirkstoff:

LEVOFLOXACIN (LEVOFLOXACIN HEMIHYDRATE)

Verfügbar ab:

SANDOZ CANADA INCORPORATED

ATC-Code:

J01MA12

INN (Internationale Bezeichnung):

LEVOFLOXACIN

Dosierung:

250MG

Darreichungsform:

TABLET

Zusammensetzung:

LEVOFLOXACIN (LEVOFLOXACIN HEMIHYDRATE) 250MG

Verabreichungsweg:

ORAL

Einheiten im Paket:

50

Verschreibungstyp:

Prescription

Therapiebereich:

QUINOLONES

Produktbesonderheiten:

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

Berechtigungsstatus:

APPROVED

Berechtigungsdatum:

2009-06-24

Fachinformation

_Sandoz Levofloxacin _
_Page 1 of 68_
PRODUCT MONOGRAPH
PR
SANDOZ LEVOFLOXACIN
Levofloxacin Tablets
250 mg, 500 mg and 750 mg Levofloxacin (anhydrous)
as Levofloxacin Hemihydrate
Antibacterial Agent
Sandoz Canada Inc.
Date of Revision: September 17, 2019
110 Rue de Lauzon
Boucherville, QC, Canada
J4B 1E6
Submission Control No: 231592
_Sandoz Levofloxacin _
_Page 2 of 68_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................................................
3
SUMMARY
PRODUCT
INFORMATION
..............................................................................................................
3
INDICATIONS
AND
CLINICAL
USE
....................................................................................................................
3
CONTRAINDICATIONS
........................................................................................................................................
5
WARNINGS
AND
PRECAUTIONS
.......................................................................................................................
5
ADVERSE
REACTIONS
.......................................................................................................................................
12
DRUG
INTERACTIONS
.......................................................................................................................................
16
DOSAGE
AND
ADMINISTRATION....................................................................................................................
18
OVERDOSAGE
.....................................................................................................................................................
20
ACTION
AND
CLINICAL
PHARMACOLOGY
..................................................................................................
21
STORAGE
AND
STABILITY
...............................................................................................................................
25
DOSAGE
FORMS,
COMPOSI