TEVA-OLMESARTAN/HCTZ TABLET

Šalis: Kanada

kalba: anglų

Šaltinis: Health Canada

Veiklioji medžiaga:

HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL

Prieinama:

TEVA CANADA LIMITED

ATC kodas:

C09DA08

INN (Tarptautinis Pavadinimas):

OLMESARTAN MEDOXOMIL AND DIURETICS

Dozė:

12.5MG; 40MG

Vaisto forma:

TABLET

Sudėtis:

HYDROCHLOROTHIAZIDE 12.5MG; OLMESARTAN MEDOXOMIL 40MG

Vartojimo būdas:

ORAL

Vienetai pakuotėje:

30

Recepto tipas:

Prescription

Gydymo sritis:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

Produkto santrauka:

Active ingredient group (AIG) number: 0252502002; AHFS:

Autorizacija statusas:

CANCELLED PRE MARKET

Leidimo data:

2021-07-29

Prekės savybės

TEVA-OLMESARTAN / HCTZ
Page 1 of 41
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
TEVA-OLMESARTAN / HCTZ
Olmesartan Medoxomil and Hydrochlorothiazide Tablets
Tablets, 20 mg / 12.5 mg, 40 mg / 12.5 mg, and 40 mg / 25 mg, Oral
Angiotensin II AT
1
Receptor Blocker – Diuretic
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9
Date of Initial Approval:
May 1, 2017
Date of Revision:
November 29, 2023
Submission Control No: 271790
TEVA-OLMESARTAN / HCTZ
Page 2 of 41
RECENT MAJOR LABEL CHANGES
TABLE OF CONTENTS
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
4.3
Reconstitution
.........................................................................................................
7
4.4
Administration
.........................................................................................................
7
4.5
Missed Dose
...........................................................................................................
7
5
OVERDOSAGE ..............................................................................