ILEVRO SUSPENSION

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

NEPAFENAC

Disponibil de la:

NOVARTIS PHARMACEUTICALS CANADA INC

Codul ATC:

S01BC10

INN (nume internaţional):

NEPAFENAC

Dozare:

0.3%

Forma farmaceutică:

SUSPENSION

Compoziție:

NEPAFENAC 0.3%

Calea de administrare:

OPHTHALMIC

Unități în pachet:

3ML

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

NONSTEROIDAL ANTI-INFLAMMATORY AGENTS

Rezumat produs:

Active ingredient group (AIG) number: 0152459002; AHFS:

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2017-02-10

Caracteristicilor produsului

_ _
_ILEVRO Product Monograph _
_Page 1 of 33 _
_ _
PRODUCT MONOGRAPH
Pr
ILEVRO
®
(Nepafenac) Ophthalmic Suspension
0.3% w/v
Nonsteroidal Anti-Inflammatory
Novartis Pharmaceuticals Canada Inc.
385 Bouchard Blvd.
Dorval, Quebec
H9S 1A9
www.novartis.ca
Submission Control No.: 206913
Date of Revision:
April 13, 2018
_ _
_ILEVRO Product Monograph _
_Page 2 of 33 _
_ _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................3
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
....................................................................................................6
DRUG INTERACTIONS
....................................................................................................8
DOSAGE AND ADMINISTRATION
................................................................................9
OVERDOSAGE
................................................................................................................10
ACTION AND CLINICAL PHARMACOLOGY
............................................................10
STORAGE AND STABILITY
..........................................................................................13
SPECIAL HANDLING INSTRUCTIONS
.......................................................................13
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................13
PART II: SCIENTIFIC INFORMATION
...............................................................................15
PHARMACEUTICAL INFORMATION
..........................................................................15
CLINICAL TRIALS
.............