ALTACE HCT TABLET

Država: Kanada

Jezik: engleski

Izvor: Health Canada

Aktivni sastojci:

RAMIPRIL; HYDROCHLOROTHIAZIDE

Dostupno od:

BAUSCH HEALTH, CANADA INC.

ATC koda:

C09BA05

INN (International ime):

RAMIPRIL AND DIURETICS

Doziranje:

2.5MG; 12.5MG

Farmaceutski oblik:

TABLET

Sastav:

RAMIPRIL 2.5MG; HYDROCHLOROTHIAZIDE 12.5MG

Administracija rute:

ORAL

Jedinice u paketu:

15G/50G

Tip recepta:

Prescription

Područje terapije:

ANGIOTENSIN-CONVERTING ENZYME INHIBITORS

Proizvod sažetak:

Active ingredient group (AIG) number: 0251649002; AHFS:

Status autorizacije:

APPROVED

Datum autorizacije:

2021-03-03

Svojstava lijeka

_Pr_
_ALTACE _
_®_
_ HCT (Ramipril and Hydrochlorothiazide Tablets) Product Monograph
Page 1 of 65_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
ALTACE
® HCT
Ramipril and hydrochlorothiazide Tablets
Tablets, 2.5/12.5 mg, 5/12.5 mg, 10/12.5 mg, 5/25 mg, 10/25 mg, Oral
Angiotensin Converting Enzyme Inhibitor Plus Diuretic
Bausch Health, Canada Inc.
2150 St-Elzear Blvd. West
Laval, Quebec
H7L 4A8
Date of Initial Authorization:
April 23, 2015
Date of Revision:
January 6, 2023
Submission Control Number: 265837
_ _
_Pr_
_ALTACE _
_®_
_ HCT (Ramipril and Hydrochlorothiazide Tablets) Product Monograph
Page 2 of 65_
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Ophthalmologic
06/2021
7 WARNINGS AND PRECAUTIONS, Respiratory
01/2023
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT
LISTED.
RECENT MAJOR LABEL CHANGES
....................................................................................
2
TABLE OF CONTENTS
.........................................................................................................
2
PART I: HEALTH PROFESSIONAL
INFORMATION..............................................................
4
1
INDICATIONS.............................................................................................................
4
1.1
Pediatrics
..........................................................................................................
4
1.2
Geriatrics...........................................................................................................
4
2
CONTRAINDICATIONS
..............................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS
BOX..................................................... 5
4
DOSAGE AND ADMINISTRATION
.............................................................................
5
4.1
Dosing Considerations
.......................................................................................
5
4.2
Recommended Dose and