RAN-EZETIMIBE TABLET

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

EZETIMIBE

Tersedia dari:

RANBAXY PHARMACEUTICALS CANADA INC.

Kode ATC:

C10AX09

INN (Nama Internasional):

EZETIMIBE

Dosis:

10MG

Bentuk farmasi:

TABLET

Komposisi:

EZETIMIBE 10MG

Rute administrasi :

ORAL

Unit dalam paket:

28/100/500

Jenis Resep:

Prescription

Area terapi:

CHOLESTEROL ABSORPTION INHIBITORS

Ringkasan produk:

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

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2014-09-15

Karakteristik produk

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_RAN™-EZETIMIBE (Ezetimibe Tablets) Product Monograph _
_Page 1 of 30_
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PRODUCT MONOGRAPH
PR
RAN
™
-EZETIMIBE
Ezetimibe Tablets
10 mg
Cholesterol Absorption Inhibitor
Ranbaxy Pharmaceuticals Canada Inc.,
2680 Matheson Blvd. E., Suite 200
Mississauga, Ontario
L4W 0A5
Date of Preparation:
January 16, 2014
SUBMISSION CONTROL NO: 158635
Trademark owned by Ranbaxy Laboratories Limited
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_Pr_
_RAN_
_™_
_-EZETIMIBE (Ezetimibe Tablets) Product Monograph _
_Page 2 of 30_
TABLE OF CONTENTS
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
..........................................................................17
CLINICAL TRIALS