RAN-FENOFIBRATE S TABLET

Država: Kanada

Jezik: engleski

Izvor: Health Canada

Aktivni sastojci:

FENOFIBRATE

Dostupno od:

RANBAXY PHARMACEUTICALS CANADA INC.

ATC koda:

C10AB05

INN (International ime):

FENOFIBRATE

Doziranje:

100MG

Farmaceutski oblik:

TABLET

Sastav:

FENOFIBRATE 100MG

Administracija rute:

ORAL

Jedinice u paketu:

10/1000

Tip recepta:

Prescription

Područje terapije:

FRIBIC ACID DERIVATIVES

Proizvod sažetak:

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

Status autorizacije:

APPROVED

Datum autorizacije:

2012-12-17

Svojstava lijeka

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PRODUCT MONOGRAPH
PR
RAN
TM
-FENOFIBRATE S
FENOFIBRATE FILM-COATED TABLETS
100 MG AND 160 MG TABLETS
LIPID METABOLISM REGULATOR
Ranbaxy Pharmaceuticals Canada Inc.
126 East Drive
Brampton, ON
L6T 1C1
Date of Revision:
July 09, 2018
Control No.: 212763
RAN trademark owned by Sun Pharmaceutical Industries Ltd.
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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
................................................................................................
8
DRUG INTERACTIONS
..............................................................................................
12
DOSAGE AND ADMINISTRATION
..........................................................................
15
OVERDOSAGE
.............................................................................................................
16
ACTION AND CLINICAL PHARMACOLOGY
......................................................... 16
STORAGE AND STABILITY
......................................................................................
17
DOSAGE FORMS, COMPOSITION AND PACKAGING
......................................... 17
PART II: SCIENTIFIC INFORMATION
...............................................................................
19
PHARMACEUTICAL INFORMATION
......................................................................
19
CLINICAL TRIALS
......................................................................................................
20
DETAILED PHARMACOLOGY
..............................................