AURO-CANDESARTAN TABLET
国家: 加拿大
语言: 英文
来源: Health Canada
产品特点
(SPC)
27-09-2018
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有效成分:
CANDESARTAN CILEXETIL
可用日期:
AURO PHARMA 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:
30/90/500
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:
2015-09-18
产品特点
Page 1 of 36
PRODUCT MONOGRAPH
PR
AURO-CANDESARTAN
candesartan cilexetil tablets
4 mg, 8 mg, 16 mg and 32 mg
House standard
Angiotensin II AT
1
Receptor Blocker
AURO PHARMA INC.
Date of Revision:
3700 Steeles Avenue West, Suite # 402
September 27, 2018
Woodbridge, Ontario, L4L 8K8
CANADA
Submission Control No: 211944
Page 2 of 36
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
...............................................................................................................
19
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 19
STORAGE AND STABILITY
.........................................................................................
22
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 22
PART II: SCIENTIFIC INFORMATION
...............................................................................
23
PHARMACEUTICAL INFORMATION
.........................................................................
23
CLINICAL TRIALS
.........................................................................................................
24
DETAILED PHARMACOLOGY
......................
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