SANDOZ FENOFIBRATE E TABLET

国: カナダ

言語: 英語

ソース: Health Canada

有効成分:

FENOFIBRATE

から入手可能:

SANDOZ CANADA INCORPORATED

ATCコード:

C10AB05

INN（国際名）:

FENOFIBRATE

投薬量:

48.0MG

医薬品形態:

TABLET

構図:

FENOFIBRATE 48.0MG

投与経路:

ORAL

パッケージ内のユニット:

30

処方タイプ:

Prescription

治療領域:

FRIBIC ACID DERIVATIVES

製品概要:

Active ingredient group (AIG) number: 0118895005; AHFS:

認証ステータス:

APPROVED

承認日:

2012-08-02

製品の特徴

_Sandoz Fenofibrate E Page 1 of 43_
PRODUCT MONOGRAPH
PR
SANDOZ FENOFIBRATE E
Fenofibrate tablets
48 mg and 145 mg
Manufacturer’s standard
Lipid Metabolism Regulator
Sandoz Canada Inc. Date of Revision: November 17, 2017
145 Jules-Léger
Boucherville, QC, Canada
J4B 7K8
Submission Control No: 204109
_ _
_Sandoz Fenofibrate E Page 2 of 43_
TABLE OF CONTENTS
PART 1: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
....................................................................................................9
DRUG INTERACTIONS
..................................................................................................13
DOSAGE AND ADMINISTRATION
..............................................................................17
OVERDOSAGE
................................................................................................................18
ACTION AND CLINICAL PHARMACOLOGY
............................................................18
STORAGE AND STABILITY
..........................................................................................20
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................20
PART II: SCIENTIFIC INFORMATION
................................................................................22
PHARMACEUTICAL INFORMATION
..........................................................................22
CLINICAL TRIALS
..........................................................................................................23
DETAILED PHARMACOLOGY
............