AA-AMILZIDE TABLET

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

HYDROCHLOROTHIAZIDE; AMILORIDE HYDROCHLORIDE

זמין מ:

AA PHARMA INC

קוד ATC:

C03EA01

INN (שם בינלאומי):

HYDROCHLOROTHIAZIDE AND POTASSIUM-SPARING AGENTS

כמות:

50MG; 5MG

טופס פרצבטיות:

TABLET

הרכב:

HYDROCHLOROTHIAZIDE 50MG; AMILORIDE HYDROCHLORIDE 5MG

מסלול נתינה (של תרופות):

ORAL

יחידות באריזה:

15G/50G

סוג מרשם:

Prescription

איזור תרפויטי:

POTASSIUM-SPARING DIURETICS

leaflet_short:

Active ingredient group (AIG) number: 0213868001; AHFS:

מצב אישור:

APPROVED

תאריך אישור:

2019-03-22

מאפייני מוצר

_AA_-_AMILZIDE (Amiloride Hydrochloride and Hydrochlorothiazide) _
_Page 1 of 43_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
AA-AMILZIDE
Amiloride Hydrochloride and Hydrochlorothiazide Tablets
Tablet, 5 mg / 50 mg, Oral
USP
Diuretic-Antihypertensive
AA PHARMA INC
1165 Creditstone Road Unit #1
Vaughan, Ontario
L4K 4N7
www.aapharma.ca/en/
Date of Initial Authorization:
MAR 13, 2019
Date of Revision:
MAR 15, 2023
Submission Control Number: 268237
_AA_-_AMILZIDE (Amiloride Hydrochloride and Hydrochlorothiazide) _
_Page 2 of 43_
RECENT
MAJOR LABEL CHANGES
4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and
Dosage Adjustment
03/2023
4 DOSAGE AND ADMINISTRATION, 4.4 Administration
03/2023
7 WARNINGS AND PRECAUTIONS, Driving and Operating
Machinery
03/2023
7 WARNINGS AND PRECAUTIONS, Respiratory
03/2023
7 WARNINGS AND PRECAUTIONS, Ophthalmologic
03/2023
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