APO-QUINAPRIL/HCTZ TABLET

국가: 캐나다

언어: 영어

출처: Health Canada

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제품 특성 요약 제품 특성 요약 (SPC)
05-03-2024

유효 성분:

QUINAPRIL (QUINAPRIL HYDROCHLORIDE); HYDROCHLOROTHIAZIDE

제공처:

APOTEX INC

ATC 코드:

C09BA06

INN (International Name):

QUINAPRIL AND DIURETICS

복용량:

20MG; 25MG

약제 형태:

TABLET

구성:

QUINAPRIL (QUINAPRIL HYDROCHLORIDE) 20MG; HYDROCHLOROTHIAZIDE 25MG

관리 경로:

ORAL

패키지 단위:

30/100

처방전 유형:

Prescription

치료 영역:

ANGIOTENSIN-CONVERTING ENZYME INHIBITORS

제품 요약:

Active ingredient group (AIG) number: 0231789003; AHFS:

승인 상태:

APPROVED

승인 날짜:

2021-06-08

제품 특성 요약

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_APO-QUINAPRIL/HCTZ (Quinapril and Hydrochlorothiazide Tablets)
PRODUCT MONOGRAPH_
_Page 1 of 61_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
APO-QUINAPRIL/HCTZ
Quinapril and Hydrochlorothiazide Tablets
Tablets, 10 mg /12.5 mg, 20 mg /12.5 mg and 20 mg /25 mg Quinapril (as
Quinapril
Hydrochloride) / Hydrochlorothiazide, Oral
House Standard
Angiotensin Converting Enzyme Inhibitor/Diuretic
Apotex. Inc.
150 Signet Drive
Toronto Ontario
M9L 1T9
Submission Control Number: 283798
Date of Initial Authorization:
JUN
28,
2013
Date of Revision:
MAR 05, 2024
_ _
_ _
_APO-QUINAPRIL/HCTZ (Quinapril and Hydrochlorothiazide Tablets)
PRODUCT MONOGRAPH_
_Page 2 of 61_
RECENT MAJOR LABEL CHANGES
N/A
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
...................................................................................................
2
TABLE OF CONTENTS
......................................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
...........................................................................
4
1
INDICATIONS
.........................................................................................................................
4
1.1
Pediatrics (<18 years of age)
........................................................................................
4
1.2
Geriatrics (> 65 years of age)
.......................................................................................
4
2
CONTRAINDICATIONS
...................................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
............................................................... 5
4
DOSAGE AND ADMINISTRATION
...................................................................................
5
4.1
Dosing Considerations
...............................................................................
                                
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