APO-QUINAPRIL/HCTZ TABLET

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

QUINAPRIL (QUINAPRIL HYDROCHLORIDE); HYDROCHLOROTHIAZIDE

Tersedia dari:

APOTEX INC

Kode ATC:

C09BA06

INN (Nama Internasional):

QUINAPRIL AND DIURETICS

Dosis:

20MG; 25MG

Bentuk farmasi:

TABLET

Komposisi:

QUINAPRIL (QUINAPRIL HYDROCHLORIDE) 20MG; HYDROCHLOROTHIAZIDE 25MG

Rute administrasi :

ORAL

Unit dalam paket:

30/100

Jenis Resep:

Prescription

Area terapi:

ANGIOTENSIN-CONVERTING ENZYME INHIBITORS

Ringkasan produk:

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

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2021-06-08

Karakteristik produk

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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
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_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
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2
TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL INFORMATION
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4
1
INDICATIONS
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4
1.1
Pediatrics (<18 years of age)
........................................................................................
4
1.2
Geriatrics (> 65 years of age)
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4
2
CONTRAINDICATIONS
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4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
............................................................... 5
4
DOSAGE AND ADMINISTRATION
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5
4.1
Dosing Considerations
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