DOM-MOXIFLOXACIN TABLET

Krajina: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktívna zložka:

MOXIFLOXACIN (MOXIFLOXACIN HYDROCHLORIDE)

Dostupné z:

DOMINION PHARMACAL

ATC kód:

J01MA14

INN (Medzinárodný Name):

MOXIFLOXACIN

Dávkovanie:

400MG

Forma lieku:

TABLET

Zloženie:

MOXIFLOXACIN (MOXIFLOXACIN HYDROCHLORIDE) 400MG

Spôsob podávania:

ORAL

Počet v balení:

10/30/100/500

Typ predpisu:

Prescription

Terapeutické oblasti:

QUINOLONES

Prehľad produktov:

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

Stav Autorizácia:

CANCELLED PRE MARKET

Dátum Autorizácia:

2019-09-13

Súhrn charakteristických

PRODUCT MONOGRAPH
PR
DOM-MOXIFLOXACIN
Moxifloxacin tablets
400 mg
(as moxifloxacin hydrochloride)
ANTIBACTERIAL AGENT
DOMINION PHARMACAL
DATE OF REVISION:
6111 Royalmount Avenue, Suite 100
December 23, 2016
Montréal, Quebec, Canada
H4P 2T4
SUBMISSION CONTROL NO:
120276
_ _
_Dom-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
INFORMATIO