TARO-RAMIPRIL HCTZ TABLET

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

RAMIPRIL; HYDROCHLOROTHIAZIDE

Tilgjengelig fra:

SUN PHARMA CANADA INC

ATC-kode:

C09BA05

INN (International Name):

RAMIPRIL AND DIURETICS

Dosering :

2.5MG; 12.5MG

Legemiddelform:

TABLET

Sammensetning:

RAMIPRIL 2.5MG; HYDROCHLOROTHIAZIDE 12.5MG

Administreringsrute:

ORAL

Enheter i pakken:

15G/50G

Resept typen:

Prescription

Terapeutisk område:

ANGIOTENSIN-CONVERTING ENZYME INHIBITORS

Produkt oppsummering:

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

Autorisasjon status:

APPROVED

Autorisasjon dato:

2020-01-06

Preparatomtale

_Pr_
_TARO-RAMIPRIL HCTZ (Ramipril/Hydrochlorothiazide Tablets) Product
Monograph _
Page 1 of 62
_ _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
TARO-RAMIPRIL HCTZ
Ramipril/Hydrochlorothiazide Tablets
Tablets, 2.5 mg ramipril/12.5 mg hydrochlorothiazide, Oral
Tablets, 5 mg ramipril/12.5 mg hydrochlorothiazide, Oral
Tablets, 10 mg ramipril/12.5 mg hydrochlorothiazide, Oral
Tablets, 5 mg ramipril/25 mg hydrochlorothiazide, Oral
Tablets, 10 mg ramipril/25 mg hydrochlorothiazide, Oral
Angiotensin Converting Enzyme Inhibitor Plus Diuretic
Sun Pharma Canada Inc.,
126 East Drive
Brampton, ON
L6T 1C1
Date of Initial Authorization:
NOV 25, 2015
Submission Control No.: 276408
Date of Revision:
OCT 05, 2023
_Pr_
_TARO-RAMIPRIL HCTZ (Ramipril/Hydrochlorothiazide Tablets) Product
Monograph _
Page 2 of 62
_ _
RECENT MAJOR LABEL CHANGES
7 WARNING AND PRECAUTIONS, Ophthalmologic
02/2022
7 WARNINGS AND PRECAUTIONS, Respiratory
10/2023
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………�