AA-FENO-SUPER TABLET
Krajina: Kanada
Jazyk: angličtina
Zdroj: Health Canada
Súhrn charakteristických
(SPC)
13-08-2021
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Aktívna zložka:
FENOFIBRATE
Dostupné z:
AA PHARMA INC
ATC kód:
C10AB05
INN (Medzinárodný Name):
FENOFIBRATE
Dávkovanie:
200MG
Forma lieku:
TABLET
Zloženie:
FENOFIBRATE 200MG
Spôsob podávania:
ORAL
Počet v balení:
100
Typ predpisu:
Prescription
Terapeutické oblasti:
FRIBIC ACID DERIVATIVES
Prehľad produktov:
Active ingredient group (AIG) number: 0118895001; AHFS:
Stav Autorizácia:
APPROVED
Dátum Autorizácia:
2021-08-17
Súhrn charakteristických
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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