MINT-IRBESARTAN TABLET

Země: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktivní složka:

IRBESARTAN

Dostupné s:

MINT PHARMACEUTICALS INC

ATC kód:

C09CA04

INN (Mezinárodní Name):

IRBESARTAN

Dávkování:

300MG

Léková forma:

TABLET

Složení:

IRBESARTAN 300MG

Podání:

ORAL

Jednotky v balení:

100

Druh předpisu:

Prescription

Terapeutické oblasti:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

Přehled produktů:

Active ingredient group (AIG) number: 0131700003; AHFS:

Stav Autorizace:

APPROVED

Datum autorizace:

2014-12-09

Charakteristika produktu

_Product Monograph MINT-IRBESARTAN (Irbesartan) _
_Page 1 of 33 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
MINT-IRBESARTAN
Irbesartan tablets
Tablets, 75, 150 and 300 mg, Oral
USP
Angiotensin II AT
1
Receptor Blocker
Mint Pharmaceuticals Inc.
6575 Davand Drive,
Mississauga, Ontario
L5T 2M3
Date of Initial Authorization:
December 19, 2014
Date of Revision:
March 27, 2023
Submission Control Number: 271580
_Product Monograph MINT-IRBESARTAN (Irbesartan) _
_Page 2 of 33 _
RECENT MAJOR LABEL CHANGES
7. WARNINGS AND PRECAUTIONS
07/2021
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
......................................................... 5
4.4
Administration
.........................................................................................................
5
4.5
Missed Do