M-EZETIMIBE TABLET

Land: Kanada

Tungumál: enska

Heimild: Health Canada

Virkt innihaldsefni:

EZETIMIBE

Fáanlegur frá:

MANTRA PHARMA INC

ATC númer:

C10AX09

INN (Alþjóðlegt nafn):

EZETIMIBE

Skammtar:

10MG

Lyfjaform:

TABLET

Samsetning:

EZETIMIBE 10MG

Stjórnsýsluleið:

ORAL

Einingar í pakka:

100/500

Gerð lyfseðils:

Prescription

Lækningarsvæði:

CHOLESTEROL ABSORPTION INHIBITORS

Vörulýsing:

Active ingredient group (AIG) number: 0149164001; AHFS:

Leyfisstaða:

APPROVED

Leyfisdagur:

2017-08-18

Vara einkenni

Page
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PRODUCT MONOGRAPH
PR
M-EZETIMIBE
Ezetimibe Tablets, USP
10 mg
Cholesterol Absorption Inhibitor
Mantra Pharma Inc.,
1000 du Lux, suite 201
Brossard, Quebec
J4Y 0E3
Control # 275104
Date
of
Revision:
MAY
30, 2023
Page
2
of
30
TABLE OF CONTENT
Table of Content
.....................................................................................................................................2
PART I: HEALTH PROFESSIONAL INFORMATION
.......................................................................3
SUMMARY PRODUCT INFORMATION
...........................................................................................3
INDICATIONS AND CLINICAL USE
............................................................................................3
CONTRAINDICATIONS
.................................................................................................................4
WARNINGS AND PRECAUTIONS
................................................................................................4
ADVERSE REACTIONS
.................................................................................................................7
DRUG INTERACTIONS
................................................................................................................11
DOSAGE AND ADMINISTRATION
............................................................................................13
OVERDOSAGE
..............................................................................................................................14
ACTION AND CLINICAL PHARMACOLOGY
..........................................................................14
STORAGE AND STABILITY
........................................................................................................16
DOSAGE FORMS, COMPOSITION AND PACKAGING
...........................................................16
PART II: SCIENTIFIC INFORMATION
............................................................................................17
PHARMACEUTICAL INFORMATION
.......