AURO-QUINAPRIL HCTZ TABLET

Krajina: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktívna zložka:

QUINAPRIL (QUINAPRIL HYDROCHLORIDE); HYDROCHLOROTHIAZIDE

Dostupné z:

AURO PHARMA INC

ATC kód:

C09BA06

INN (Medzinárodný Name):

QUINAPRIL AND DIURETICS

Dávkovanie:

10MG; 12.5MG

Forma lieku:

TABLET

Zloženie:

QUINAPRIL (QUINAPRIL HYDROCHLORIDE) 10MG; HYDROCHLOROTHIAZIDE 12.5MG

Spôsob podávania:

ORAL

Počet v balení:

2X14/90

Typ predpisu:

Prescription

Terapeutické oblasti:

ANGIOTENSIN-CONVERTING ENZYME INHIBITORS

Prehľad produktov:

Active ingredient group (AIG) number: 0231789001; AHFS:

Stav Autorizácia:

APPROVED

Dátum Autorizácia:

2019-01-02

Súhrn charakteristických

_AURO-QUINAPRIL HCTZ PRODUCT MONOGRAPH _
Page 1 of 56
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
AURO-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
AURO PHARMA INC
3700 Steeles Avenue West, Suite # 402
Woodbridge, Ontario, L4L 8K8
Canada
Date of Initial Authorization:
January 02, 2019
Date of Revision:
August 11, 2023
Submission Control Number: 272657
_AURO-QUINAPRIL HCTZ PRODUCT MONOGRAPH _
Page 2 of 56
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
.................................................................................................
5
4.2 Recommended Dose and Dosage Adjustment
...............