M-EZETIMIBE TABLET

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

EZETIMIBE

Tersedia dari:

MANTRA PHARMA INC

Kode ATC:

C10AX09

INN (Nama Internasional):

EZETIMIBE

Dosis:

10MG

Bentuk farmasi:

TABLET

Komposisi:

EZETIMIBE 10MG

Rute administrasi :

ORAL

Unit dalam paket:

100/500

Jenis Resep:

Prescription

Area terapi:

CHOLESTEROL ABSORPTION INHIBITORS

Ringkasan produk:

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

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2017-08-18

Karakteristik produk

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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
.......