TEVA-MOXIFLOXACIN SOLUTION

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

MOXIFLOXACIN (MOXIFLOXACIN HYDROCHLORIDE)

Commercializzato da:

TEVA CANADA LIMITED

Codice ATC:

S01AE07

INN (Nome Internazionale):

MOXIFLOXACIN

Dosaggio:

0.5%

Forma farmaceutica:

SOLUTION

Composizione:

MOXIFLOXACIN (MOXIFLOXACIN HYDROCHLORIDE) 0.5%

Via di somministrazione:

OPHTHALMIC

Confezione:

5ML

Tipo di ricetta:

Prescription

Area terapeutica:

ANTIBACTERIALS

Dettagli prodotto:

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

Stato dell'autorizzazione:

APPROVED

Data dell'autorizzazione:

2015-11-10

Scheda tecnica

_ _
_TEVA-MOXIFLOXACIN OPHTHALMIC SOLUTION _
_1 _
PRODUCT MONOGRAPH
PR
TEVA-MOXIFLOXACIN
Moxifloxacin Ophthalmic Solution, USP
0.5% w/v moxifloxacin (as moxifloxacin hydrochloride)
Sterile
ANTIBACTERIAL (OPHTHALMIC)
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9
Submission Control No: 186529
Date of Revision:
August 11, 2015
_ _
_TEVA-MOXIFLOXACIN OPHTHALMIC SOLUTION _
_2 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT INFORMATION
...................................................................................
3
INDICATIONS AND CLINICAL USE
.........................................................................................
3
CONTRAINDICATIONS
..............................................................................................................
3
WARNINGS AND PRECAUTIONS
.............................................................................................
4
ADVERSE REACTIONS
...............................................................................................................
6
DOSAGE AND ADMINISTRATION
...........................................................................................
7
OVERDOSE
...................................................................................................................................
7
ACTION AND CLINICAL PHARMACOLOGY
.........................................................................
8
STORAGE AND STABILITY
.......................................................................................................
8
DOSAGE FORMS, COMPOSITION AND PACKAGING
.......................................................... 9
PART II: SCIENTIFIC INFORMATION
...............................................................................
10
PHARMACEUTICAL INFORMATION
.....................................................................................
10
CLINICAL STUDIES
....................................................................