ALREX SUSPENSION

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

LOTEPREDNOL ETABONATE

Saatavilla:

BAUSCH & LOMB INC

ATC-koodi:

S01BA14

INN (Kansainvälinen yleisnimi):

LOTEPREDNOL

Annos:

0.2%

Lääkemuoto:

SUSPENSION

Koostumus:

LOTEPREDNOL ETABONATE 0.2%

Antoreitti:

OPHTHALMIC

Kpl paketissa:

5ML

Prescription tyyppi:

Prescription

Terapeuttinen alue:

CORTICOSTEROIDS

Tuoteyhteenveto:

Active ingredient group (AIG) number: 0152508001; AHFS:

Valtuutuksen tilan:

APPROVED

Valtuutus päivämäärä:

2008-12-23

Valmisteyhteenveto

1
PRODUCT MONOGRAPH
PR
Alrex
®
(loteprednol etabonate ophthalmic suspension 0.2% w/v)
Corticosteroid
Professed Standard
Bausch and Lomb, Inc.
Rochester, NY 14609
www.bausch.com
Distributed in Canada by:
Bausch and Lomb Canada, Inc.
Vaughan, Ontario L4K 4B4
Date of Preparation:
December 22, 2008
Submission Control No: 117199
2
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......................................................................................7
DRUG INTERACTIONS
....................................................................................11
DOSAGE AND
ADMINISTRATION................................................................11
OVERDOSAGE
..................................................................................................12
ACTION AND CLINICAL PHARMACOLOGY
..............................................12
STORAGE AND
STABILITY............................................................................12
SPECIAL HANDLING INSTRUCTIONS
.........................................................13
DOSAGE FORMS, COMPOSITION AND PACKAGING
...............................13
PART II: SCIENTIFIC INFORMATION
.................................................................14
PHARMACEUTICAL
INFORMATION............................................................14
CLINICAL
TRIALS............................................................................................14
DETAILED
PHARMACOLOGY.......................................................................17
MICROBIOLOGY
....................................................................