ENALAPRIL/HCTZ TABLET

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

ENALAPRIL SODIUM; HYDROCHLOROTHIAZIDE

Dostępny od:

FROSST A DIVISION OF MERCK CANADA INC

Kod ATC:

C09BA02

INN (International Nazwa):

ENALAPRIL AND DIURETICS

Dawkowanie:

8MG; 25MG

Forma farmaceutyczna:

TABLET

Skład:

ENALAPRIL SODIUM 8MG; HYDROCHLOROTHIAZIDE 25MG

Droga podania:

ORAL

Sztuk w opakowaniu:

28

Typ recepty:

Prescription

Dziedzina terapeutyczna:

ANGIOTENSIN-CONVERTING ENZYME INHIBITORS

Podsumowanie produktu:

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

Status autoryzacji:

CANCELLED PRE MARKET

Data autoryzacji:

2016-05-05

Charakterystyka produktu

_ENALAPRIL/HCTZ (enalapril and hydrochlorothiazide tablets) _
_Page 1 of 44_
PRODUCT MONOGRAPH
PR ENALAPRIL/HCTZ
(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
FROSST, A DIVISION OF MERCK CANADA INC Date of Revision:
16750 route Transcanadienne
March 21, 2016
Kirkland, QC Canada
H9H 4M7
SUBMISSION CONTROL NO: 192763
_ENALAPRIL/HCTZ (enalapril and hydrochlorothiazide tablets) _
_Page 2 of 44_
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
..................................................................................................14
DOSAGE AND ADMINISTRATION
..............................................................................19
OVERDOSAGE
................................................................................................................20
ACTION AND CLINICAL PHARMACOLOGY
............................................................21
STORAGE AND STABILITY
..........................................................................................25
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................25
PART II: SCIENTIFIC INFORMATION
...............................................................................26
PHARMACEUTI