APO-IRBESARTAN TABLET

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

IRBESARTAN

제공처:

APOTEX INC

ATC 코드:

C09CA04

INN (International Name):

IRBESARTAN

복용량:

300MG

약제 형태:

TABLET

구성:

IRBESARTAN 300MG

관리 경로:

ORAL

패키지 단위:

100/500

처방전 유형:

Prescription

치료 영역:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

제품 요약:

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

승인 상태:

APPROVED

승인 날짜:

2012-05-25

제품 특성 요약

_Product Monograph Master Template _
_APO-IRBESARTAN _
Page 1 of 35
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
APO-IRBESARTAN
Irbesartan tablets
Tablets, 75 mg, 150 mg and 300 mg, Oral
USP
Angiotensin II AT
1
Receptor Blocker
APOTEX INC.
150 SIGNET DRIVE
TORONTO, ONTARIO
M9L 1T9
Date of Initial Authorization:
May 24, 2012
Date of Revision:
August 12, 2021
Submission Control Number: 251515
_Product Monograph Master Template _
_APO-IRBESARTAN _
Page 2 of 35
RECENT MAJOR LABEL CHANGES
7. WARNINGS AND PRECAUTIONS
08/2021
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 Essential Hypertension
................................ 5
4.4 Administration
...........................................................................................................
6
4.5 Missed Dose
........