SANDOZ IRBESARTAN TABLET

Krajina: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktívna zložka:

IRBESARTAN

Dostupné z:

SANDOZ CANADA INCORPORATED

ATC kód:

C09CA04

INN (Medzinárodný Name):

IRBESARTAN

Dávkovanie:

75MG

Forma lieku:

TABLET

Zloženie:

IRBESARTAN 75MG

Spôsob podávania:

ORAL

Počet v balení:

30/100/500

Typ predpisu:

Prescription

Terapeutické oblasti:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

Prehľad produktov:

Active ingredient group (AIG) number: 0131700001; AHFS:

Stav Autorizácia:

APPROVED

Dátum Autorizácia:

2011-03-21

Súhrn charakteristických

_Sandoz Irbesartan _
_ _
_Page 1 of 37 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
SANDOZ IRBESARTAN
irbesartan tablets
Tablets, 75 mg, 150 mg and 300 mg, Oral
House Standard
Angiotensin II AT
1
Receptor Blocker
Sandoz Canada Inc.
110, De Lauzon Street
Boucherville, QC, Canada
J4B 1E6
Date of Initial Authorization
Mar 21, 2011
Date of revision
May 19, 2023
Submission Control No.: 271479
_Sandoz Irbesartan _
_ _
_Page 2 of 37 _
RECENT MAJOR LABEL CHANGES
7. WARNINGS AND PRECAUTIONS
05/2023
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
.................................