APO-MOXIFLOXACIN SOLUTION

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

MOXIFLOXACIN (MOXIFLOXACIN HYDROCHLORIDE)

Commercializzato da:

APOTEX 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:

2015-11-04

Scheda tecnica

PRODUCT MONOGRAPH
PR
APO-MOXIFLOXACIN
Moxifloxacin Ophthalmic Solution USP
0.5% w/v (as moxifloxacin hydrochloride)
Sterile
Antibacterial (ophthalmic)
APOTEX INC.
DATE OF REVISION:
150 SIGNET DRIVE
DECEMBER 31, 2018
TORONTO, ONTARIO
M9L 1T9
CONTROL NO.: 222971
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 ...................................................................................
7
OVERDOSAGE ......................................................................................................................
7
ACTION AND CLINICAL PHARMACOLOGY .................................................................. 8
STORAGE AND STABILITY ...............................................................................................
9
DOSAGE FORMS, COMPOSITION AND PACKAGING .................................................. 9
PART II: SCIENTIFIC INFORMATION
.......................................................................
10
PHARMACEUTICAL INFORMATION .............................................................................
10
CLINICAL TRIALS .............................................................................................................
11
DETAILED PHARMACOLOGY ...............................................