PHL-MOXIFLOXACIN TABLET

Land: Canada

Sprog: engelsk

Kilde: Health Canada

Aktiv bestanddel:

MOXIFLOXACIN (MOXIFLOXACIN HYDROCHLORIDE)

Tilgængelig fra:

PHARMEL INC

ATC-kode:

J01MA14

INN (International Name):

MOXIFLOXACIN

Dosering:

400MG

Lægemiddelform:

TABLET

Sammensætning:

MOXIFLOXACIN (MOXIFLOXACIN HYDROCHLORIDE) 400MG

Indgivelsesvej:

ORAL

Enheder i pakken:

10/30/100/500

Recept type:

Prescription

Terapeutisk område:

QUINOLONES

Produkt oversigt:

Active ingredient group (AIG) number: 0142242001; AHFS:

Autorisation status:

CANCELLED PRE MARKET

Autorisation dato:

2017-09-13

Produktets egenskaber

PRODUCT MONOGRAPH
PR
PHL-MOXIFLOXACIN
Moxifloxacin tablets
400 mg
(as moxifloxacin hydrochloride)
ANTIBACTERIAL AGENT
PHARMEL INC.
DATE OF REVISION:
6111 Royalmount Avenue, Suite 100
December 23, 2016
Montréal, Quebec, Canada
H4P 2T4
SUBMISSION CONTROL NO:
120275
_ _
_phl-MOXIFLOXACIN Product Monograph _
_Page 2 of 67 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................... 3
SUMMARY
PRODUCT
INFORMATION
...................................................................................
3
INDICATIONS
AND
CLINICAL
USE
.........................................................................................
3
CONTRAINDICATIONS
..............................................................................................................
5
WARNINGS
AND
PRECAUTIONS
.............................................................................................
6
ADVERSE
REACTIONS
............................................................................................................
14
DRUG
INTERACTIONS
.............................................................................................................
18
DOSAGE
AND
ADMINISTRATION
.........................................................................................
21
OVERDOSAGE
...........................................................................................................................
22
ACTION
AND
CLINICAL
PHARMACOLOGY
.......................................................................
23
STORAGE
AND
STABILITY
.....................................................................................................
31
SPECIAL
HANDLING
INSTRUCTIONS
..................................................................................
31
DOSAGE
FORMS,
COMPOSITION
AND
PACKAGING ........................................................ 32
PART II: SCIENTIFIC INFORMATION
..................................................................................
33
PHARMACEUTICAL
INFORMATION
....