PMS-MOXIFLOXACIN TABLET

Land: Canada

Sprog: engelsk

Kilde: Health Canada

Aktiv bestanddel:

MOXIFLOXACIN (MOXIFLOXACIN HYDROCHLORIDE)

Tilgængelig fra:

PHARMASCIENCE INC

ATC-kode:

J01MA14

INN (International Name):

MOXIFLOXACIN

Dosering:

400MG

Lægemiddelform:

TABLET

Sammensætning:

MOXIFLOXACIN (MOXIFLOXACIN HYDROCHLORIDE) 400MG

Indgivelsesvej:

ORAL

Enheder i pakken:

100

Recept type:

Prescription

Terapeutisk område:

QUINOLONES

Produkt oversigt:

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

Autorisation status:

APPROVED

Autorisation dato:

2015-12-21

Produktets egenskaber

_ _
_pms-MOXIFLOXACIN Product Monograph _
_Page 1 of 69 _
PRODUCT MONOGRAPH
PR
PMS-MOXIFLOXACIN
Moxifloxacin Tablets
400 mg
(as moxifloxacin hydrochloride)
ANTIBACTERIAL AGENT
PHARMASCIENCE INC.
DATE OF REVISION:
6111 Royalmount Avenue, Suite 100
May 9, 2019
Montréal, Canada
H4P 2T4
www.pharmascience.com
SUBMISSION CONTROL NO: 225692
_ _
_pms-MOXIFLOXACIN Product Monograph _
_Page 2 of 69 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................ 3
SUMMARY
PRODUCT
INFORMATION
................................................................................
3
INDICATIONS
AND
CLINICAL
USE
.....................................................................................
3
CONTRAINDICATIONS
..........................................................................................................
6
WARNINGS
AND
PRECAUTIONS
.........................................................................................
6
ADVERSE
REACTIONS
.........................................................................................................
15
DRUG
INTERACTIONS
.........................................................................................................
19
DOSAGE
AND
ADMINISTRATION
.....................................................................................
21
OVERDOSAGE
.......................................................................................................................
22
ACTION
AND
CLINICAL
PHARMACOLOGY
....................................................................
23
STORAGE
AND
STABILITY
.................................................................................................
31
SPECIAL
HANDLING
INSTRUCTIONS
...............................................................................
31
DOSAGE
FORMS,
COMPOSITION
AND
PACKAGING ..................................................... 31
PART II: SCIENTIFIC INFORMATION
..............................................................................
32
PHARMACEU