DOM-LEVOFLOXACIN TABLET

Pajjiż: Kanada

Lingwa: Ingliż

Sors: Health Canada

Ingredjent attiv:

LEVOFLOXACIN (LEVOFLOXACIN HEMIHYDRATE)

Disponibbli minn:

DOMINION PHARMACAL

Kodiċi ATC:

J01MA12

INN (Isem Internazzjonali):

LEVOFLOXACIN

Dożaġġ:

500MG

Għamla farmaċewtika:

TABLET

Kompożizzjoni:

LEVOFLOXACIN (LEVOFLOXACIN HEMIHYDRATE) 500MG

Rotta amministrattiva:

ORAL

Unitajiet fil-pakkett:

50/100

Tip ta 'preskrizzjoni:

Prescription

Żona terapewtika:

QUINOLONES

Sommarju tal-prodott:

Active ingredient group (AIG) number: 0131663004; AHFS:

L-istatus ta 'awtorizzazzjoni:

CANCELLED PRE MARKET

Data ta 'l-awtorizzazzjoni:

2019-09-13

Karatteristiċi tal-prodott

PRODUCT MONOGRAPH
PR DOM-LEVOFLOXACIN
Levofloxacin
Tablets 250 mg, 500 mg and 750 mg
(as Levofloxacin hemihydrate)
Antibacterial Agent
DOMINION PHARMACAL
6111 Royalmount Ave., Suite 100
Montréal, Canada
H4P 2T4
Date of Revision:
February 20, 2013
Submission Control No: 162068
_ _
_Dom-LEVOFLOXACIN Product Monograph _
_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
.................................................................................................
10
DRUG INTERACTIONS
.................................................................................................
14
DOSAGE AND ADMINISTRATION
.............................................................................
17
OVERDOSAGE
................................................................................................................
19
ACTION AND CLINICAL PHARMACOLOGY
............................................................ 19
STORAGE AND STABILITY
.........................................................................................
25
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................. 25
PART II: SCIENTIFIC INFORMATION
...............................................................................
26
PHARMACEUTICAL INFORMATION
.........................................................................
26
CLINICAL TRIALS
.........................................................................................................
27
DETAILED PHARMACOLOGY
................