SANDOZ FENOFIBRATE E TABLET

国家: 加拿大

语言: 英文

来源: Health Canada

有效成分:

FENOFIBRATE

可用日期:

SANDOZ CANADA INCORPORATED

ATC代码:

C10AB05

INN（国际名称）:

FENOFIBRATE

剂量:

145.0MG

药物剂型:

TABLET

组成:

FENOFIBRATE 145.0MG

给药途径:

ORAL

每包单位数:

30

处方类型:

Prescription

治疗领域:

FRIBIC ACID DERIVATIVES

產品總結:

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

授权状态:

APPROVED

授权日期:

2012-08-02

产品特点

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