TEVA-TELMISARTAN TABLET

البلد: كندا

اللغة: الإنجليزية

المصدر: Health Canada

العنصر النشط:

TELMISARTAN

متاح من:

TEVA CANADA LIMITED

ATC رمز:

C09CA07

INN (الاسم الدولي):

TELMISARTAN

جرعة:

80MG

الشكل الصيدلاني:

TABLET

تركيب:

TELMISARTAN 80MG

طريقة التعاطي:

ORAL

الوحدات في الحزمة:

28/30/100/500

نوع الوصفة الطبية :

Prescription

المجال العلاجي:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

ملخص المنتج:

Active ingredient group (AIG) number: 0138223002; AHFS:

الوضع إذن:

APPROVED

تاريخ الترخيص:

2012-01-06

خصائص المنتج

TEVA-TELMISARTAN
Page 1 of 38
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
TEVA-TELMISARTAN
Telmisartan Tablets
Tablet, 40 mg and 80 mg, Oral
USP
Angiotensin II AT1 Receptor Blocker
Teva Canada Limited
30 Novopharm Court
Toronto, ON
M1B 2K9
Canada
www.tevacanada.com
Date of Initial Authorization:
January 06, 2012
Date of Revision:
August 15, 2023
Submission Control No: 272815
TEVA-TELMISARTAN
Page 2 of 38
RECENT MAJOR LABEL CHANGES
2 CONTRAINDICATIONS
08/2023
7 WARNINGS AND PRECAUTIONS
08/2023
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
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
................................................................ 5
4
DOSAGE AND ADMINISTRATION
.....................................................................................
5
4.1 Dosing Considerations
......................................................................................................
5
4.2 Recommended Dose and Dosage Adjustment
................................................................. 5
4.4 Administration
......................................