TEVA-ENALAPRIL/HCTZ TABLET

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

ENALAPRIL SODIUM; HYDROCHLOROTHIAZIDE

Pieejams no:

TEVA CANADA LIMITED

ATĶ kods:

C09BA02

SNN (starptautisko nepatentēto nosaukumu):

ENALAPRIL AND DIURETICS

Deva:

8MG; 25MG

Zāļu forma:

TABLET

Kompozīcija:

ENALAPRIL SODIUM 8MG; HYDROCHLOROTHIAZIDE 25MG

Ievadīšanas:

ORAL

Vienības iepakojumā:

30/100

Receptes veids:

Prescription

Ārstniecības joma:

ANGIOTENSIN-CONVERTING ENZYME INHIBITORS

Produktu pārskats:

Active ingredient group (AIG) number: 0252326001; AHFS:

Autorizācija statuss:

CANCELLED POST MARKET

Autorizācija datums:

2018-06-15

Produkta apraksts

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
...........................................................................