APO-IRBESARTAN TABLET

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

IRBESARTAN

Commercializzato da:

APOTEX INC

Codice ATC:

C09CA04

INN (Nome Internazionale):

IRBESARTAN

Dosaggio:

150MG

Forma farmaceutica:

TABLET

Composizione:

IRBESARTAN 150MG

Via di somministrazione:

ORAL

Confezione:

100/500

Tipo di ricetta:

Prescription

Area terapeutica:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

Dettagli prodotto:

Active ingredient group (AIG) number: 0131700002; AHFS:

Stato dell'autorizzazione:

APPROVED

Data dell'autorizzazione:

2012-05-25

Scheda tecnica

_Product Monograph Master Template _
_APO-IRBESARTAN _
Page 1 of 35
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
APO-IRBESARTAN
Irbesartan tablets
Tablets, 75 mg, 150 mg and 300 mg, Oral
USP
Angiotensin II AT
1
Receptor Blocker
APOTEX INC.
150 SIGNET DRIVE
TORONTO, ONTARIO
M9L 1T9
Date of Initial Authorization:
May 24, 2012
Date of Revision:
August 12, 2021
Submission Control Number: 251515
_Product Monograph Master Template _
_APO-IRBESARTAN _
Page 2 of 35
RECENT MAJOR LABEL CHANGES
7. WARNINGS AND PRECAUTIONS
08/2021
TABLE OF CONTENTS
RECENT MAJOR LABEL CHANGES
..............................................................................................
2
TABLE OF CONTENTS ..............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION .........................................................................
4
1
INDICATIONS
................................................................................................................
4
1.1
Pediatrics
.................................................................................................................
4
1.2
Geriatrics
.................................................................................................................
4
2
CONTRAINDICATIONS ...................................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX .................................................................. 4
4
DOSAGE AND ADMINISTRATION
.....................................................................................
5
4.1 Dosing Considerations
.................................................................................................
5
4.2
Recommended Dose and Dosage Adjustment Essential Hypertension
................................ 5
4.4 Administration
...........................................................................................................
6
4.5 Missed Dose
........