TARO-CANDESARTAN TABLET

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

CANDESARTAN CILEXETIL

Sẵn có từ:

SUN PHARMA CANADA INC

Mã ATC:

C09CA06

INN (Tên quốc tế):

CANDESARTAN

Liều dùng:

32MG

Dạng dược phẩm:

TABLET

Thành phần:

CANDESARTAN CILEXETIL 32MG

Tuyến hành chính:

ORAL

Các đơn vị trong gói:

30

Loại thuốc theo toa:

Prescription

Khu trị liệu:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

Tóm tắt sản phẩm:

Active ingredient group (AIG) number: 0135220004; AHFS:

Tình trạng ủy quyền:

APPROVED

Ngày ủy quyền:

2020-03-04

Đặc tính sản phẩm

_ _
_PR_
_TARO-CANDESARTAN (CANDESARTAN CILEXETIL) TABLETS_
_ _
_Page 1 of 39_
PRODUCT MONOGRAPH
PR
TARO–CANDESARTAN
candesartan cilexetil tablets
4 mg, 8 mg, 16 mg and 32 mg
Angiotensin II AT
1
Receptor Blocker
Sun Pharma Canada Inc.
126 East Drive
Brampton, Ontario
L6T 1C1
Date of Revision:
March 2, 2020
Submission Control Number: 236155
_ _
_PR_
_TARO-CANDESARTAN (CANDESARTAN CILEXETIL) TABLETS_
_ _
_Page 2 of 39_
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
..................................................................................................15
DOSAGE AND ADMINISTRATION
..............................................................................19
OVERDOSAGE
................................................................................................................21
ACTION AND CLINICAL PHARMACOLOGY
............................................................22
STORAGE AND STABILITY
..........................................................................................24
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................24
PART II: SCIENTIFIC INFORMATION
....................................................................................26
PHARMACEUTICAL INFORMATION
..........................................................................26
CLINICAL TRIALS
......................................................