IRBESARTAN TABLET

Šalis: Kanada

kalba: anglų

Šaltinis: Health Canada

Veiklioji medžiaga:

IRBESARTAN

Prieinama:

SIVEM PHARMACEUTICALS ULC

ATC kodas:

C09CA04

INN (Tarptautinis Pavadinimas):

IRBESARTAN

Dozė:

300MG

Vaisto forma:

TABLET

Sudėtis:

IRBESARTAN 300MG

Vartojimo būdas:

ORAL

Vienetai pakuotėje:

100/500

Recepto tipas:

Prescription

Gydymo sritis:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

Produkto santrauka:

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

Autorizacija statusas:

APPROVED

Leidimo data:

2012-05-25

Prekės savybės

_IRBESARTAN _
_Page 1 of 37_
_ _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
IRBESARTAN
Irbesartan tablets
Tablets, 75 mg, 150 mg and 300 mg, Oral
USP
Angiotensin II AT
1
Receptor Blocker
Sivem Pharmaceuticals ULC
4705 Dobrin Street
Saint-Laurent, Quebec, Canada
H4R 2P7
www.sivem.ca
Date of Initial Authorization
MAY 25, 2012
Date of revision
JAN 02, 2024
Submission Control No.: 281898
_IRBESARTAN _
_Page 2 of 37_
_ _
RECENT MAJOR LABEL CHANGES
7. WARNINGS AND PRECAUTIONS
01/2024
TABLE OF CONTENTS
RECENT MAJOR LABEL
CHANGES………………………………………………………………………….…...............2
TABLES 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
............................................................ 5
4
DOSAGE AND ADMINISTRATION
.................................................................................
5
4.1
Dosing Considerations
..............................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
......................................................... 5
4.4
Administration
..........................................................................................................
6
4.5
Missed Dose
...............................................