SEPTA-CANDESARTAN TABLET

国家: 加拿大

语言: 英文

来源: Health Canada

有效成分:

CANDESARTAN CILEXETIL

可用日期:

SEPTA PHARMACEUTICALS INC

ATC代码:

C09CA06

INN（国际名称）:

CANDESARTAN

剂量:

16MG

药物剂型:

TABLET

组成:

CANDESARTAN CILEXETIL 16MG

给药途径:

ORAL

每包单位数:

100

处方类型:

Prescription

治疗领域:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

產品總結:

Active ingredient group (AIG) number: 0135220003; AHFS:

授权状态:

APPROVED

授权日期:

2015-10-20

产品特点

_SEPTA-CANDESARTAN – Product Monograph _
_ Page 1 of 30_
PRODUCT MONOGRAPH
Pr
SEPTA-CANDESARTAN
candesartan cilexetil tablets
16 mg and 32 mg
Angiotensin II AT
1
Receptor Blocker
Septa Pharmaceuticals Inc.
7490 Pacific Circle, Unit # 1
Mississauga, ON L5T 2A3
Canada
Date of Preparation:
October 16, 2015
SUBMISSION CONTROL NO: 187806
_ _
_SEPTA-CANDESARTAN – Product Monograph Page 2 of 30 _
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
....................................................................................................7
DRUG INTERACTIONS
..................................................................................................12
DOSAGE AND ADMINISTRATION
..............................................................................14
OVERDOSAGE…………………………………………………………………………16
ACTION AND CLINICAL PHARMACOLOGY
............................................................17
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................19
PART II: SCIENTIFIC INFORMATION
...............................................................................20
PHARMACEUTICAL INFORMATION
..........................................................................20
CLINICAL TRIALS
..........................................................................................................21
DETAILED PHARMACOLOGY
.....................................................................................23
TOXICOLOGY
......................