APO-LEVOFLOXACIN TABLET

Pajjiż: Kanada

Lingwa: Ingliż

Sors: Health Canada

Ingredjent attiv:

LEVOFLOXACIN (LEVOFLOXACIN HEMIHYDRATE)

Disponibbli minn:

APOTEX INC

Kodiċi ATC:

J01MA12

INN (Isem Internazzjonali):

LEVOFLOXACIN

Dożaġġ:

250MG

Għamla farmaċewtika:

TABLET

Kompożizzjoni:

LEVOFLOXACIN (LEVOFLOXACIN HEMIHYDRATE) 250MG

Rotta amministrattiva:

ORAL

Unitajiet fil-pakkett:

100

Tip ta 'preskrizzjoni:

Prescription

Żona terapewtika:

QUINOLONES

Sommarju tal-prodott:

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

L-istatus ta 'awtorizzazzjoni:

APPROVED

Data ta 'l-awtorizzazzjoni:

2009-06-24

Karatteristiċi tal-prodott

Page 1 of 69
PRODUCT MONOGRAPH
PR
APO-LEVOFLOXACIN
(levofloxacin)
250 mg, 500 mg and 750 mg Tablets
Apotex Standard
Antibacterial Agent
APOTEX INC.
DATE OF REVISION:
150 Signet Drive
August 30, 2019
Toronto, Ontario
M9L 1T9
Control number: 231101
Page 2 of 69
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
.......................................................................................................
17
DOSAGE AND ADMINISTRATION
...................................................................................
19
OVERDOSAGE
......................................................................................................................
22
ACTION AND CLINICAL PHARMACOLOGY
................................................................. 22
STORAGE AND STABILITY
...............................................................................................
27
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................. 27
PART II: SCIENTIFIC INFORMATION
..............................................................................
29
PHARMACEUTICAL INFORMATION
...............................................................................
29
CLINICAL TRIALS
...............................................................................................................
30
DETAILED PHARMACOLOGY
..................