TEVA-CANDESARTAN TABLET

국가: 캐나다

언어: 영어

출처: Health Canada

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제품 특성 요약 제품 특성 요약 (SPC)
09-05-2016

유효 성분:

CANDESARTAN CILEXETIL

제공처:

TEVA CANADA LIMITED

ATC 코드:

C09CA06

INN (International Name):

CANDESARTAN

복용량:

32MG

약제 형태:

TABLET

구성:

CANDESARTAN CILEXETIL 32MG

관리 경로:

ORAL

패키지 단위:

30

처방전 유형:

Prescription

치료 영역:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

제품 요약:

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

승인 상태:

APPROVED

승인 날짜:

2012-02-10

제품 특성 요약

                                PRODUCT MONOGRAPH
PR
TEVA-CANDESARTAN
Candesartan cilexetil Tablets
8 mg, 16 mg, and 32 mg
Angiotensin II AT
1
Receptor Blocker
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9
Control No. 194121
Date of Revision:
May 2, 2016
2
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
.....................................................................................
13
DOSAGE AND ADMINISTRATION
................................................................. 15
OVERDOSAGE
...................................................................................................
17
ACTION AND CLINICAL PHARMACOLOGY
............................................... 18
STORAGE AND STABILITY
.............................................................................
20
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................ 20
PART II: SCIENTIFIC INFORMATION
....................................................................................
22
PHARMACEUTICAL INFORMATION
............................................................. 22
CLINICAL TRIALS
.............................................................................................
23
DETAILED PHARMACOLOGY
........................................................................
26
TOXICOLOGY
....................................................................................................
26
REFERENCES
.......................................................
                                
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