APO-IRBESARTAN/HCTZ TABLET

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

IRBESARTAN; HYDROCHLOROTHIAZIDE

Disponibil de la:

APOTEX INC

Codul ATC:

C09DA04

INN (nume internaţional):

IRBESARTAN AND DIURETICS

Dozare:

300MG; 12.5MG

Forma farmaceutică:

TABLET

Compoziție:

IRBESARTAN 300MG; HYDROCHLOROTHIAZIDE 12.5MG

Calea de administrare:

ORAL

Unități în pachet:

100/500

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

Rezumat produs:

Active ingredient group (AIG) number: 0240086002; AHFS:

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2012-06-12

Caracteristicilor produsului

Page 1 of 54
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
APO-IRBESARTAN/HCTZ
(Irbesartan and hydrochlorothiazide Tablets USP)
150/12.5 mg, 300/12.5 mg and 300/25 mg, Oral
Angiotensin II AT
1 Receptor
Blocker / Diuretic
APOTEX INC.
150 Signet Drive
Toronto, Ontario
M9L 1T9
Date of Initial Authorization:
June 12, 2012
Date of Revision:
September 29, 2021
Submission Control No.: 251965
Page 2 of 54
RECENT MAJOR LABEL CHANGES
7. Warnings and Precautions
10/2021
TABLE OF CONTENT
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 Dosage Adjustment
......................................................................
5
4.4 Administration
.............................................................................................................................
6
4.5 Missed Dose
................................................................................................................................
6
5
OVERDOSAGE
................................................................................