MOXIFLOXACIN SOLUTION

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

MOXIFLOXACIN (MOXIFLOXACIN HYDROCHLORIDE)

Commercializzato da:

SANIS HEALTH 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:

15G/50G

Tipo di ricetta:

Prescription

Dettagli prodotto:

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

Stato dell'autorizzazione:

APPROVED

Data dell'autorizzazione:

2022-07-18

Scheda tecnica

PRODUCT MONOGRAPH
PR
MOXIFLOXACIN
Moxifloxacin Ophthalmic Solution USP
0.5% w/v (as moxifloxacin hydrochloride)
Sterile
Antibacterial (ophthalmic)
Sanis Health Inc.
Date of Preparation:
1 President's Choice Circle
July 14, 2022
Brampton, Ontario
L6Y 5S5
Control No.: 264818
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
..................................