PERINDOPRIL/INDAPAMIDE TABLET

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

PERINDOPRIL ERBUMINE; INDAPAMIDE

Sẵn có từ:

SANIS HEALTH INC

Mã ATC:

C09BA04

INN (Tên quốc tế):

PERINDOPRIL AND DIURETICS

Liều dùng:

4MG; 1.25MG

Dạng dược phẩm:

TABLET

Thành phần:

PERINDOPRIL ERBUMINE 4MG; INDAPAMIDE 1.25MG

Tuyến hành chính:

ORAL

Các đơn vị trong gói:

15G/50G

Loại thuốc theo toa:

Prescription

Khu trị liệu:

ANGIOTENSIN-CONVERTING ENZYME INHIBITORS

Tóm tắt sản phẩm:

Active ingredient group (AIG) number: 0248401001; AHFS:

Tình trạng ủy quyền:

APPROVED

Ngày ủy quyền:

2021-08-30

Đặc tính sản phẩm

_ _
_PERINDOPRIL/INDAPAMIDE Page 1 of 73 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
PERINDOPRIL/INDAPAMIDE
Perindopril Erbumine and Indapamide Tablets
Tablets, 2 mg/0.625 mg, 4 mg/1.25 mg and 8 mg/2.5 mg, Oral
Angiotensin converting enzyme inhibitor / Diuretic
Sanis Health Inc.
1 President's Choice Circle
Brampton, Ontario
L6Y 5S5
Submission Control Number: 276619
Date of Initial Authorization:
AUG 30, 2021
Date of
Revision:
JUL
17, 2023
_ _
_PERINDOPRIL/INDAPAMIDE Page 2 of 73 _
RECENT MAJOR LABEL CHANGES
2 CONTRAINDICATIONS
07/2023
7 WARNING AND PRECAUTIONS
07/2023
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 (<18 years of age)
..........................................................................................................
4
1.2 Geriatrics (> 65 years of age)
.........................................................................................................
4
2 CONTRAINDICATIONS
................................................................................................................
4
3 SERIOUS WARNINGS AND PRECAUTIONS BOX
...........................................................................
5
4 DOSAGE AND ADMINISTRATION
................................................................................................
6
4.1 Dosing Considerations
...................................................................................................................
6
4.2 Rec