AA-FENO-SUPER TABLET
Land: Canada
Språk: engelsk
Kilde: Health Canada
Preparatomtale
(SPC)
13-08-2021
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Aktiv ingrediens:
FENOFIBRATE
Tilgjengelig fra:
AA PHARMA INC
ATC-kode:
C10AB05
INN (International Name):
FENOFIBRATE
Dosering :
200MG
Legemiddelform:
TABLET
Sammensetning:
FENOFIBRATE 200MG
Administreringsrute:
ORAL
Enheter i pakken:
100
Resept typen:
Prescription
Terapeutisk område:
FRIBIC ACID DERIVATIVES
Produkt oppsummering:
Active ingredient group (AIG) number: 0118895001; AHFS:
Autorisasjon status:
APPROVED
Autorisasjon dato:
2021-08-17
Preparatomtale
Page 1 of 38
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
AA-FENO-SUPER
FENOFIBRATE TABLETS
HOUSE STANDARD
100 MG, 160 MG AND 200 MG
LIPID METABOLISM REGULATOR
AA PHARMA INC.
DATE OF REVISION:
1165 CREDITSTONE ROAD UNIT #1
AUGUST 13, 2021
VAUGHAN, ONTARIO
L4K 4N7
CONTROL # 254380
Page 2 of 38
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
....................................................................................................................
16
OVERDOSAGE
......................................................................................................................................................
16
ACTION AND CLINICAL PHARMACOLOGY
..................................................................................................
17
STORAGE AND STABILITY
................................................................................................................................
18
DOSAGE FORMS, COMPOSITION AND PACKAGING
.....................................
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