NRA-TELMISARTAN HCTZ TABLET

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

TELMISARTAN; HYDROCHLOROTHIAZIDE

Sẵn có từ:

NORA PHARMA INC

Mã ATC:

C09DA07

INN (Tên quốc tế):

TELMISARTAN AND DIURETICS

Liều dùng:

80MG; 25MG

Dạng dược phẩm:

TABLET

Thành phần:

TELMISARTAN 80MG; HYDROCHLOROTHIAZIDE 25MG

Tuyến hành chính:

ORAL

Các đơn vị trong gói:

15G/50G

Loại thuốc theo toa:

Prescription

Khu trị liệu:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

Tóm tắt sản phẩm:

Active ingredient group (AIG) number: 0244783002; AHFS:

Tình trạng ủy quyền:

APPROVED

Ngày ủy quyền:

2020-08-25

Đặc tính sản phẩm

_NRA-Telmisartan - Product Monograph _
_1 of 31 _
PRODUCT MONOGRAPH
PR
NRA-TELMISARTAN
Telmisartan Tablets
40 mg and 80 mg
Manufacturer’s Standard
Angiotensin II AT
1
Receptor Blocker
Nora Pharma Inc.
1565 Lionel-Boulet Blvd.
Varennes, Québec
J3X 1P7 Canada
SUBMISSION CONTROL NO.:
266032
Date of
Revision:
August 9, 2022
_NRA-Telmisartan - Product Monograph _
_2 of 31 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT INFORMATION
...............................................................................
3
INDICATIONS AND CLINICAL USE
.....................................................................................
3
CONTRAINDICATIONS
..........................................................................................................
4
WARNINGS AND PRECAUTIONS
.........................................................................................
4
ADVERSE REACTIONS
...........................................................................................................
8
DRUG INTERACTIONS
.........................................................................................................
14
DOSAGE AND ADMINISTRATION
.....................................................................................
16
OVERDOSAGE
.......................................................................................................................
17
ACTION AND CLINICAL PHARMACOLOGY
................................................................... 17
STORAGE AND STABILITY
.................................................................................................
20
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 20
PART II: SCIENTIFIC INFORMATION
...............................................................................
21
PHARMACEUTICAL INFORMATION
.................................................................................
21
CLINICAL TRIALS
..............