VASERETIC TABLET

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

ENALAPRIL SODIUM; HYDROCHLOROTHIAZIDE

Mevcut itibaren:

MERCK CANADA INC

ATC kodu:

C09BA02

INN (International Adı):

ENALAPRIL AND DIURETICS

Doz:

4MG; 12.5MG

Farmasötik formu:

TABLET

Kompozisyon:

ENALAPRIL SODIUM 4MG; HYDROCHLOROTHIAZIDE 12.5MG

Uygulama yolu:

ORAL

Paketteki üniteler:

30

Reçete türü:

Prescription

Terapötik alanı:

ANGIOTENSIN-CONVERTING ENZYME INHIBITORS

Ürün özeti:

Active ingredient group (AIG) number: 0252326002; AHFS:

Yetkilendirme durumu:

CANCELLED POST MARKET

Yetkilendirme tarihi:

2008-05-06

Ürün özellikleri

_ _
_VASERETIC_
®
_ (enalapril and hydrochlorothiazide tablets) _
_Page 1 of 42_
PRODUCT MONOGRAPH
VASERETIC
®
(enalapril and hydrochlorothiazide tablets)
10 mg/25 mg
Each tablet is made with 10 mg of enalapril maleate that appears as 8
mg of enalapril sodium in
the tablet and 25 mg of hydrochlorothiazide.
Angiotensin Converting Enzyme Inhibitor / Diuretic
MERCK CANADA INC.
Date of revision:
16750 route Transcanadienne
June 14, 2019
Kirkland, QC Canada
H9H 4M7
www.merck.ca
SUBMISSION CONTROL NO:
224595
_ _
_VASERETIC_
®
_ (enalapril and hydrochlorothiazide tablets) _
_Page 2 of 42_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
..........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
..................................................................................................10
DRUG INTERACTIONS
..................................................................................................15
DOSAGE AND ADMINISTRATION
..............................................................................19
OVERDOSAGE
................................................................................................................20
ACTION AND CLINICAL PHARMACOLOGY
............................................................21
STORAGE AND STABILITY
..........................................................................................23
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................23
PART II: SCIENTIFIC INFORMATION
................................................................................25
PHARMACEUTICAL