CILOXAN SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE)

Available from:

NOVARTIS PHARMACEUTICALS CANADA INC

ATC code:

S03AA07

INN (International Name):

CIPROFLOXACIN

Dosage:

0.3%

Pharmaceutical form:

SOLUTION

Composition:

CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) 0.3%

Administration route:

OPHTHALMIC

Units in package:

5ML/10ML

Prescription type:

Prescription

Therapeutic area:

ANTIBACTERIALS

Product summary:

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

Authorization status:

APPROVED

Authorization date:

2017-04-03

Summary of Product characteristics

_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............