OTIXAL SOLUTION

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE); FLUOCINOLONE ACETONIDE

Disponible depuis:

MEDEXUS PHARMACEUTICALS INC.

Code ATC:

S02CA05

DCI (Dénomination commune internationale):

FLUOCINOLONE ACETONIDE AND ANTIINFECTIVES

Dosage:

0.3%; 0.025%

forme pharmaceutique:

SOLUTION

Composition:

CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) 0.3%; FLUOCINOLONE ACETONIDE 0.025%

Mode d'administration:

OTIC

Unités en paquet:

0.25ML

Type d'ordonnance:

Prescription

Domaine thérapeutique:

ANTIBACTERIALS

Descriptif du produit:

Active ingredient group (AIG) number: 0258670001; AHFS:

Statut de autorisation:

APPROVED

Date de l'autorisation:

2016-12-08

Résumé des caractéristiques du produit

_Page 1 of 28_
_OTIXAL™ Product Monograph_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
OTIXAL
TM
Ciprofloxacin and Fluocinolone acetonide Otic Solution
0.3% w/v ciprofloxacin (as ciprofloxacin hydrochloride) and 0.025% w/v
fluocinolone acetonide
Antibacterial - Corticosteroid
Medexus Inc.
35 Nixon Road, Unit 1
Bolton, Ontario
L7E 1K1
Submission Control No.: 270667
Date of Preparation:
JAN
23, 2023
_ _
_OTIXAL™ Product Monograph _
_Page 2 of 28 _
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
....................................................................................................8
DOSAGE AND ADMINISTRATION
................................................................................8
OVERDOSAGE
..................................................................................................................9
ACTION AND CLINICAL PHARMACOLOGY
..............................................................9
STORAGE AND STABILITY
..........................................................................................10
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................10
PART II: SCIENTIFIC INFORMATION
...............................................................................11
PHARMACEUTICAL INFORMATION
..........................................................................11
CLINICAL TRIALS
...........