TEVA-ENALAPRIL/HCTZ TABLET

Država: Kanada

Jezik: engleski

Izvor: Health Canada

Aktivni sastojci:

ENALAPRIL SODIUM; HYDROCHLOROTHIAZIDE

Dostupno od:

TEVA CANADA LIMITED

ATC koda:

C09BA02

INN (International ime):

ENALAPRIL AND DIURETICS

Doziranje:

4MG; 12.5MG

Farmaceutski oblik:

TABLET

Sastav:

ENALAPRIL SODIUM 4MG; HYDROCHLOROTHIAZIDE 12.5MG

Administracija rute:

ORAL

Jedinice u paketu:

30

Tip recepta:

Prescription

Područje terapije:

ANGIOTENSIN-CONVERTING ENZYME INHIBITORS

Proizvod sažetak:

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

Status autorizacije:

CANCELLED POST MARKET

Datum autorizacije:

2018-06-15

Svojstava lijeka

PRODUCT MONOGRAPH
PR
TEVA-ENALAPRIL/HCTZ
Enalapril / Hydrochlorothiazide Tablets
5 mg/12.5 mg and 10 mg/25 mg
Professed Standard
Each tablet is made with 5 or 10 mg of enalapril maleate that appears
as 4 or 8 mg of
enalapril sodium, and 12.5 mg or 25 mg of hydrochlorothiazide,
respectively
Angiotensin Converting Enzyme Inhibitor / Diuretic
Teva Canada Limited
Date of Revision:
30 Novopharm Court
July 23, 2015
Toronto ON M1B 2K9
CANADA
www.tevacanada.com
Submission Control No: 185425
2
PART I: HEALTH PROFESSIONAL
INFORMATION................................................... 3
SUMMARY PRODUCT INFORMATION
................................................................... 3
INDICATIONS AND CLINICAL USE
.........................................................................
3
CONTRAINDICATIONS
..............................................................................................
3
WARNINGS AND PRECAUTIONS
.............................................................................
4
ADVERSE REACTIONS
...............................................................................................
9
DRUG INTERACTIONS
.............................................................................................
13
DOSAGE AND ADMINISTRATION
.........................................................................
15
OVERDOSAGE
...........................................................................................................
16
ACTION AND CLINICAL PHARMACOLOGY
....................................................... 16
STORAGE AND STABILITY
.....................................................................................
19
DOSAGE FORMS, COMPOSITION AND PACKAGING
........................................ 19
PART II: SCIENTIFIC INFORMATION
........................................................................
21
PHARMACEUTICAL INFORMATION
.....................................................................
21
CLINICAL TRIALS
...........................................................................