FENOMAX CAPSULE

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

FENOFIBRATE

Saatavilla:

CIPHER PHARMACEUTICALS INC

ATC-koodi:

C10AB05

INN (Kansainvälinen yleisnimi):

FENOFIBRATE

Annos:

100MG

Lääkemuoto:

CAPSULE

Koostumus:

FENOFIBRATE 100MG

Antoreitti:

ORAL

Kpl paketissa:

100

Prescription tyyppi:

Prescription

Terapeuttinen alue:

FRIBIC ACID DERIVATIVES

Tuoteyhteenveto:

Active ingredient group (AIG) number: 0118895002; AHFS:

Valtuutuksen tilan:

APPROVED

Valtuutus päivämäärä:

2006-07-27

Valmisteyhteenveto

Page 1 of 29
PRODUCT MONOGRAPH
PR
FENOMAX™
(Fenofibrate Capsules)
100 MG AND 160 MG CAPSULES
Professed Standard
LIPID METABOLISM REGULATOR
Cipher Pharmaceuticals Ltd.
Suite 201
Lauriston, Collymore Rock
St. Michael, Barbados
IMPORTED AND DISTRIBUTED BY:
Oryx Pharmaceuticals Inc., a subsidiary
of Arrow Pharmaceuticals Inc.
6500 Kitimat Road
Mississauga, Ontario
Canada, L5N 2B8
Date of Revision:
October 18, 2006
Control Nos.:
105932
105933
105934
Page 2 of 29
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.............................................................................
10
OVERDOSAGE
...............................................................................................................
10
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 10
STORAGE AND
STABILITY.........................................................................................
12
SPECIAL HANDLING INSTRUCTIONS
......................................................................
12
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 12
PART II: SCIENTIFIC INFORMATION
..............................................................................
13
PHARMACEUTICAL
INFORMATION..................