CILOXAN SOLUTION

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE)

Disponibil de la:

NOVARTIS PHARMACEUTICALS CANADA INC

Codul ATC:

S03AA07

INN (nume internaţional):

CIPROFLOXACIN

Dozare:

0.3%

Forma farmaceutică:

SOLUTION

Compoziție:

CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) 0.3%

Calea de administrare:

OPHTHALMIC

Unități în pachet:

5ML/10ML

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

ANTIBACTERIALS

Rezumat produs:

Active ingredient group (AIG) number: 0123207004; AHFS:

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2017-04-03

Caracteristicilor produsului

_CILOXAN_
_®_
_ Product Monograph _
_ _
1
_ _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
CILOXAN
®
Ciprofloxacin Ophthalmic Solution, USP
0.3% w/v (as ciprofloxacin hydrochloride)
Antibacterial Agent
and
Pr
CILOXAN
®
Ciprofloxacin Ophthalmic Ointment, USP
0.3% w/w (as ciprofloxacin hydrochloride)
Antibacterial Agent
Novartis Pharmaceuticals Canada Inc.
385 Bouchard Blvd.
Dorval, Quebec
H9S 1A9
Date of Revision:
www.novartis.ca
May 22, 2018
Submission Control No.: 210590
CILOXAN and DROP-TAINER are registered trademarks.
_CILOXAN_
_®_
_ Product Monograph _
_ _
2
_ _
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
....................................................................................................7
DRUG INTERACTIONS
....................................................................................................8
DOSAGE AND ADMINISTRATION
................................................................................8
ACTION AND CLINICAL PHARMACOLOGY
............................................................10
STORAGE AND STABILITY
..........................................................................................10
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................10
PART II: SCIENTIFIC INFORMATION
................................................................................11
DETAILED PHARMACOLOGY
.....................................................................................11
MICROBIOLOGY............