AURO-QUINAPRIL HCTZ TABLET

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

QUINAPRIL (QUINAPRIL HYDROCHLORIDE); HYDROCHLOROTHIAZIDE

Mevcut itibaren:

AURO PHARMA INC

ATC kodu:

C09BA06

INN (International Adı):

QUINAPRIL AND DIURETICS

Doz:

20MG; 12.5MG

Farmasötik formu:

TABLET

Kompozisyon:

QUINAPRIL (QUINAPRIL HYDROCHLORIDE) 20MG; HYDROCHLOROTHIAZIDE 12.5MG

Uygulama yolu:

ORAL

Paketteki üniteler:

2X14/90

Reçete türü:

Prescription

Terapötik alanı:

ANGIOTENSIN-CONVERTING ENZYME INHIBITORS

Ürün özeti:

Active ingredient group (AIG) number: 0231789002; AHFS:

Yetkilendirme durumu:

APPROVED

Yetkilendirme tarihi:

2019-01-02

Ürün özellikleri

_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
...............