SANDOZ FENOFIBRATE E TABLET

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

FENOFIBRATE

제공처:

SANDOZ CANADA INCORPORATED

ATC 코드:

C10AB05

INN (국제 이름):

FENOFIBRATE

복용량:

145.0MG

약제 형태:

TABLET

구성:

FENOFIBRATE 145.0MG

관리 경로:

ORAL

패키지 단위:

30

처방전 유형:

Prescription

치료 영역:

FRIBIC ACID DERIVATIVES

제품 요약:

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

승인 상태:

APPROVED

승인 날짜:

2012-08-02

제품 특성 요약

_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
............