LESCOL 20MG CAPSULE

Држава: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

FLUVASTATIN (FLUVASTATIN SODIUM)

Доступно од:

NOVARTIS PHARMACEUTICALS CANADA INC

АТЦ код:

C10AA04

INN (Међународно име):

FLUVASTATIN

Дозирање:

20MG

Фармацеутски облик:

CAPSULE

Састав:

FLUVASTATIN (FLUVASTATIN SODIUM) 20MG

Пут администрације:

ORAL

Јединице у пакету:

100

Тип рецептора:

Prescription

Терапеутска област:

HMG-COA REDUCTASE INHIBITORS

Резиме производа:

Active ingredient group (AIG) number: 0125247002; AHFS:

Статус ауторизације:

CANCELLED POST MARKET

Датум одобрења:

2018-09-21

Карактеристике производа

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_Page 1 of 67_
PRODUCT MONOGRAPH
Pr
LESCOL
®
Fluvastatin sodium capsules
20 and 40 mg
Pr
LESCOL
®
XL
Fluvastatin sodium extended release tablets
80 mg
Lipid Metabolism Regulator
Novartis Pharmaceuticals Canada Inc.
Dorval, Quebec
H9S 1A9
DATE OF REVISION:
August 26, 2016
CONTROL NUMBER: 195234
LESCOL is a registered trademark
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_Page 2 of 67_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
..........................................................3
SUMMARY PRODUCT INFORMATION
.....................................................................3
INDICATIONS AND CLINICAL USE
...........................................................................3
CONTRAINDICATIONS
.................................................................................................5
WARNINGS AND PRECAUTIONS
...............................................................................6
ADVERSE REACTIONS
................................................................................................17
DRUG INTERACTIONS
................................................................................................22
DOSAGE AND ADMINISTRATION
...........................................................................28
ACTION AND CLINICAL PHARMACOLOGY
........................................................32
STORAGE AND
STABILITY........................................................................................36
SPECIAL HANDLING INSTRUCTIONS
....................................................................36
DOSAGE FORMS, COMPOSITION AND PACKAGING
........................................36
PART II: SCIENTIFIC INFORMATION
...............................................................................38
PHARMACEUTICAL INFORMATION
......................................................................38
CLINICAL TRIALS
........................................................................................................39
DETAILED PHARMACOLOGY
........................................................