TARO-RAMIPRIL HCTZ TABLET

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

RAMIPRIL; HYDROCHLOROTHIAZIDE

Sẵn có từ:

SUN PHARMA CANADA INC

Mã ATC:

C09BA05

INN (Tên quốc tế):

RAMIPRIL AND DIURETICS

Liều dùng:

2.5MG; 12.5MG

Dạng dược phẩm:

TABLET

Thành phần:

RAMIPRIL 2.5MG; HYDROCHLOROTHIAZIDE 12.5MG

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: 0251649002; AHFS:

Tình trạng ủy quyền:

APPROVED

Ngày ủy quyền:

2020-01-06

Đặc tính sản phẩm

_Pr_
_TARO-RAMIPRIL HCTZ (Ramipril/Hydrochlorothiazide Tablets) Product
Monograph _
Page 1 of 62
_ _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
TARO-RAMIPRIL HCTZ
Ramipril/Hydrochlorothiazide Tablets
Tablets, 2.5 mg ramipril/12.5 mg hydrochlorothiazide, Oral
Tablets, 5 mg ramipril/12.5 mg hydrochlorothiazide, Oral
Tablets, 10 mg ramipril/12.5 mg hydrochlorothiazide, Oral
Tablets, 5 mg ramipril/25 mg hydrochlorothiazide, Oral
Tablets, 10 mg ramipril/25 mg hydrochlorothiazide, Oral
Angiotensin Converting Enzyme Inhibitor Plus Diuretic
Sun Pharma Canada Inc.,
126 East Drive
Brampton, ON
L6T 1C1
Date of Initial Authorization:
NOV 25, 2015
Submission Control No.: 276408
Date of Revision:
OCT 05, 2023
_Pr_
_TARO-RAMIPRIL HCTZ (Ramipril/Hydrochlorothiazide Tablets) Product
Monograph _
Page 2 of 62
_ _
RECENT MAJOR LABEL CHANGES
7 WARNING AND PRECAUTIONS, Ophthalmologic
02/2022
7 WARNINGS AND PRECAUTIONS, Respiratory
10/2023
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………�