PMS-MOXIFLOXACIN SOLUTION

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

MOXIFLOXACIN (MOXIFLOXACIN HYDROCHLORIDE)

Commercializzato da:

PHARMASCIENCE INC

Codice ATC:

S01AE07

INN (Nome Internazionale):

MOXIFLOXACIN

Dosaggio:

0.5%

Forma farmaceutica:

SOLUTION

Composizione:

MOXIFLOXACIN (MOXIFLOXACIN HYDROCHLORIDE) 0.5%

Via di somministrazione:

OPHTHALMIC

Confezione:

3ML

Tipo di ricetta:

Prescription

Area terapeutica:

ANTIBACTERIALS

Dettagli prodotto:

Active ingredient group (AIG) number: 0142242003; AHFS:

Stato dell'autorizzazione:

APPROVED

Data dell'autorizzazione:

2015-12-18

Scheda tecnica

PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
PMS-MOXIFLOXACIN
Moxifloxacin Ophthalmic Solution
0.5% w/v moxifloxacin (as moxifloxacin hydrochloride)
USP
STERILE
ANTIBACTERIAL (OPHTHALMIC)
PHARMASCIENCE INC.
Date of Revision:
6111 Royalmount Ave., Suite 100
April 25, 2018
Montréal, Canada
H4P 2T4
www.pharmascience.com
Submission Control No: 214389
_pms-MOXIFLOXACIN Product Monograph _
_Page 2 of 29_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
...................................................... 3
SUMMARY PRODUCT INFORMATION
.....................................................................
3
INDICATIONS AND CLINICAL USE
...........................................................................
3
CONTRAINDICATIONS
................................................................................................
4
WARNINGS AND PRECAUTIONS
..............................................................................
4
ADVERSE REACTIONS
................................................................................................
6
DRUG INTERACTIONS
.................................................................................................
7
DOSAGE AND ADMINISTRATION
.............................................................................
8
OVERDOSAGE
...............................................................................................................
8
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 9
STORAGE AND STABILITY
......................................................................................
10
DOSAGE FORMS, COMPOSITION AND PACKAGING
.......................................... 10
PART II: SCIENTIFIC INFORMATION
.............................................................................
12
PHARMACEUTICAL INFORMATION
......................................................................
12
CLINICAL TRIALS
..............................................................................................