SEPTA-CANDESARTAN HCTZ TABLET
국가: 캐나다
언어: 영어
출처: Health Canada
제품 특성 요약
(SPC)
28-04-2015
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유효 성분:
HYDROCHLOROTHIAZIDE; CANDESARTAN CILEXETIL
제공처:
SEPTA PHARMACEUTICALS INC
ATC 코드:
C09DA06
INN (국제 이름):
CANDERSARTAN AND DIURETICS
복용량:
25MG; 32MG
약제 형태:
TABLET
구성:
HYDROCHLOROTHIAZIDE 25MG; CANDESARTAN CILEXETIL 32MG
관리 경로:
ORAL
패키지 단위:
30/80/1000
처방전 유형:
Prescription
치료 영역:
ANGIOTENSIN II RECEPTOR ANTAGONISTS
제품 요약:
Active ingredient group (AIG) number: 0244181003; AHFS:
승인 상태:
APPROVED
승인 날짜:
2015-04-29
제품 특성 요약
Page 1 of 38
_Septa-Candesartan HCTZ_
PRODUCT
MONOGRAPH
PR
SEPTA-CANDESARTAN HCTZ
CANDESARTAN CILEXETIL/HYDROCHLOROTHIAZIDE TABLETS
32 MG / 12.5 MG,
32 MG / 25 MG
ANGIOTENSIN II AT1 RECEPTOR BLOCKER + DIURETIC
Septa Pharmaceuticals Inc
Date of Preparation:
7490 Pacific Circle, # 1
April 22, 2015
Mississauga, ON L5T 2A3
Canada
Submission Control Number : 183582
Page 2 of 38
_Septa-Candesartan HCTZ_
TABLE OF CONTENTS
CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.................................................................................................
3
INDICATIONS AND CLINICAL USE
...........................................................................................
3
CONTRAINDICATIONS
.................................................................................................................
4
WARNINGS AND PRECAUTIONS
...............................................................................................
4
ADVERSE REACTIONS
.................................................................................................................
9
DRUG INTERACTIONS
...............................................................................................................
13
DOSAGE AND ADMINISTRATION
...........................................................................................
18
OVERDOSAGE
..............................................................................................................................
20
ACTION AND CLINICAL PHARMACOLOGY
..........................................................................
20
STORAGE AND STABILITY
.......................................................................................................
23
DOSAGE FORMS, COMPOSITION AND PACKAGING
........................................................... 24
PART II: SCIENTIFIC INFORMATION
...................................................................................................................
25
PHARMACEUTICAL INFORMATION
..................................................
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