MYLAN-CANDESARTAN HCTZ TABLET

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE

제공처:

MYLAN PHARMACEUTICALS ULC

ATC 코드:

C09DA06

INN (국제 이름):

CANDERSARTAN AND DIURETICS

복용량:

16.0MG; 12.5MG

약제 형태:

TABLET

구성:

CANDESARTAN CILEXETIL 16.0MG; HYDROCHLOROTHIAZIDE 12.5MG

관리 경로:

ORAL

패키지 단위:

30/100

처방전 유형:

Prescription

치료 영역:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

제품 요약:

Active ingredient group (AIG) number: 0244181001; AHFS:

승인 상태:

CANCELLED POST MARKET

승인 날짜:

2017-01-11

제품 특성 요약

PAGE 1 OF 45
PRODUCT MONOGRAPH
PR
MYLAN-CANDESARTAN HCTZ
Candesartan Cilexetil/Hydrochlorothiazide Tablets
16 mg / 12.5 mg, 32 mg / 12.5 mg and 32 mg / 25 mg
Angiotensin II AT
1
Receptor Blocker + Diuretic
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke, ON
M8Z 2S6
Date of Revision: April 18, 2016
Submission Control No.: 193747
PAGE 2 OF 45
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY
PRODUCT
INFORMATION
................................................................................
3
INDICATIONS
AND
CLINICAL
USE
.....................................................................................
3
CONTRAINDICATIONS
..........................................................................................................
3
WARNINGS
AND
PRECAUTIONS
.........................................................................................
5
ADVERSE
REACTIONS
.........................................................................................................
10
DRUG
INTERACTIONS
.........................................................................................................
15
DOSAGE
AND
ADMINISTRATION
.....................................................................................
20
OVERDOSAGE
.......................................................................................................................
22
ACTION
AND
CLINICAL
PHARMACOLOGY
....................................................................
23
STORAGE
AND
STABILITY
.................................................................................................
26
DOSAGE
FORMS,
COMPOSITION
AND
PACKAGING ..................................................... 26
PART II: SCIENTIFIC INFORMATION
...............................................................................
28
PHARMACEUTICAL
INFORMATION
.................................................................................
28
CLINICAL
TRIALS
........................................