OLMETEC TABLET

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

OLMESARTAN MEDOXOMIL

Boleh didapati daripada:

ORGANON CANADA INC.

Kod ATC:

C09CA08

INN (Nama Antarabangsa):

OLMESARTAN MEDOXOMIL

Dos:

40MG

Borang farmaseutikal:

TABLET

Komposisi:

OLMESARTAN MEDOXOMIL 40MG

Laluan pentadbiran:

ORAL

Unit dalam pakej:

15G/50G

Jenis preskripsi:

Prescription

Kawasan terapeutik:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

Ringkasan produk:

Active ingredient group (AIG) number: 0152496003; AHFS:

Status kebenaran:

APPROVED

Tarikh kebenaran:

2011-02-15

Ciri produk

_OLMETEC_
_®_
_ _
_(olmesartan medoxomil)_
_ _
_Page 1 of 28_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
OLMETEC
®
Olmesartan Medoxomil Tablets
5 mg
_*_
, 20 mg, and 40 mg Tablets
Oral
Angiotensin II AT
1
Receptor Blocker
ORGANON CANADA INC.
16766 route Transcanadienne
Kirkland, Quebec
H9H 4M7
www.organon.ca
Date of Initial Approval:
October 28, 2008
Date of Revision:
April 28, 2021
Submission Control No.: 250401
_*5 mg tablet not marketed_
_OLMETEC_
_®_
_ _
_(olmesartan medoxomil)_
_ _
_Page 2 of 28_
RECENT MAJOR LABEL CHANGES
Contraindications, Pregnancy and Breastfeeding, November 2020
Warnings and Precautions, Special Populations, Pregnant women,
November 2020
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
................................................................ 4
1
INDICATIONS
................................................................................................................
4
Pediatrics
........................................................................................................................
4
Geriatrics
........................................................................................................................
4
2
CONTRAINDICATIONS
.................................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
....................................................... 5
4
DOSAGE AND ADMINISTRATION
................................................................................
5
4.1 Dosing Considerations
..............................................................................................
5
4.2 Recommended Dose and Dosage
Adjustment.......................................................... 6
4.3 Reconstitution
...........................................................................................................
6
4.4 Administration
...........................................................................................................
6
4.5 Missed Dose
......