TEVA-IRBESARTAN TABLET

البلد: كندا

اللغة: الإنجليزية

المصدر: Health Canada

العنصر النشط:

IRBESARTAN

متاح من:

TEVA CANADA LIMITED

ATC رمز:

C09CA04

INN (الاسم الدولي):

IRBESARTAN

جرعة:

300MG

الشكل الصيدلاني:

TABLET

تركيب:

IRBESARTAN 300MG

طريقة التعاطي:

ORAL

الوحدات في الحزمة:

100

نوع الوصفة الطبية :

Prescription

المجال العلاجي:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

ملخص المنتج:

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

الوضع إذن:

APPROVED

تاريخ الترخيص:

2018-06-11

خصائص المنتج

_TEVA-IRBESARTAN Page 1 of 40_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
TEVA-IRBESARTAN
Irbesartan tablets
Tablets, 75, 150 and 300 mg, Oral
Teva Standard
Angiotensin II AT
1
Receptor Blocker
Teva Canada Limited
30 Novopharm Court
Toronto, ON
M1B 2K9
Canada
www.tevacanada.com
Date of Initial Authorization
September 14, 2009
Date of Revision:
February 17, 2023
Submission Control Number: 271205
_TEVA-IRBESARTAN Page 2 of 40_
RECENT MAJOR LABEL CHANGES
7. WARNINGS AND PRECAUTIONS
07/2021
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
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
_
................