APO-QUINAPRIL/HCTZ TABLET

Land: Kanada

Språk: engelska

Källa: Health Canada

Aktiva substanser:

QUINAPRIL (QUINAPRIL HYDROCHLORIDE); HYDROCHLOROTHIAZIDE

Tillgänglig från:

APOTEX INC

ATC-kod:

C09BA06

INN (International namn):

QUINAPRIL AND DIURETICS

Dos:

20MG; 25MG

Läkemedelsform:

TABLET

Sammansättning:

QUINAPRIL (QUINAPRIL HYDROCHLORIDE) 20MG; HYDROCHLOROTHIAZIDE 25MG

Administreringssätt:

ORAL

Enheter i paketet:

30/100

Receptbelagda typ:

Prescription

Terapiområde:

ANGIOTENSIN-CONVERTING ENZYME INHIBITORS

Produktsammanfattning:

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

Bemyndigande status:

APPROVED

Tillstånd datum:

2021-06-08

Produktens egenskaper

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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
...............................................................................