TARO-FENOFIBRATE E TABLET

Country: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

FENOFIBRATE

Доступно од:

SUN PHARMA CANADA INC

АТЦ код:

C10AB05

INN (Међународно име):

FENOFIBRATE

Дозирање:

145MG

Фармацеутски облик:

TABLET

Састав:

FENOFIBRATE 145MG

Пут администрације:

ORAL

Јединице у пакету:

10/30/500

Тип рецептора:

Prescription

Терапеутска област:

FRIBIC ACID DERIVATIVES

Резиме производа:

Active ingredient group (AIG) number: 0118895006; AHFS:

Статус ауторизације:

APPROVED

Датум одобрења:

2016-05-12

Карактеристике производа

_Page 1 of 41_
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_TARO-FENOFIBRATE E (Fenofibrate Tablets, Mfr. Std.) Product Monograph
_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
TARO-FENOFIBRATE E
Fenofibrate Tablets, Mfr. Std.
145 mg
LIPID METABOLISM REGULATOR
Sun Pharma Canada Inc.
126 East Drive
Brampton, ON
L6T 1C1
Date of Revision:
July 13, 2020
Submission Control No: 234145
_Page 2 of 41_
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_TARO-FENOFIBRATE E (Fenofibrate Tablets, Mfr. Std.) Product Monograph
_
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
......................................................................
17
STORAGE AND STABILITY
....................................................................................................
18
DOSAGE FORMS, COMPOSITION AND PACKAGING
....................................................... 19
PART II: SCIENTIFIC INFORMATION
..............................................................................
20
PHARMACEUTICAL INFORMATION
......