APO-RAMIPRIL/HCTZ TABLET

Страна: Канада

Език: английски

Източник: Health Canada

Активна съставка:

HYDROCHLOROTHIAZIDE; RAMIPRIL

Предлага се от:

APOTEX INC

АТС код:

C09BA05

INN (Международно Name):

RAMIPRIL AND DIURETICS

дозиране:

12.5MG; 2.5MG

Лекарствена форма:

TABLET

Композиция:

HYDROCHLOROTHIAZIDE 12.5MG; RAMIPRIL 2.5MG

Начин на приложение:

ORAL

Броя в опаковка:

30/100

Вид предписание :

Prescription

Терапевтична област:

ANGIOTENSIN-CONVERTING ENZYME INHIBITORS

Каталог на резюме:

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

Статус Оторизация:

APPROVED

Дата Оторизация:

2010-07-02

Данни за продукта

_ _
_ _
_Pr_
_APO-RAMIPRIL/HCTZ, ramipril/hydrochlorothiazide _
_Page 1 of 62_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
APO-RAMIPRIL/HCTZ
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
APOTEX INC.
150 Signet Drive
Toronto, Ontario M9L 1T9
Date of Initial Authorization:
JUL 02, 2010
Date of Revision:
APR 28, 2022
Submission Control Number: 258626
_ _
_ _
_Pr_
_APO-RAMIPRIL/HCTZ, ramipril/hydrochlorothiazide _
_Page 2 of 62_
RECENT MAJOR LABEL CHANGES
7 WARNING AND PRECAUTIONS
04/2022
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
WARNINGS AND PRECAUTIONS BOX
.........................................................................................
5
4
DOSAGE AND
ADMINISTRATION...............................................................................................
6
4.1 Dosing
Considerations..................................................................................