PRZ-OLMESARTAN/HCTZ TABLET

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

OLMESARTAN MEDOXOMIL; HYDROCHLOROTHIAZIDE

Dostopno od:

PHARMARIS CANADA INC

Koda artikla:

C09DA08

INN (mednarodno ime):

OLMESARTAN MEDOXOMIL AND DIURETICS

Odmerek:

40MG; 25MG

Farmacevtska oblika:

TABLET

Sestava:

OLMESARTAN MEDOXOMIL 40MG; HYDROCHLOROTHIAZIDE 25MG

Pot uporabe:

ORAL

Enote v paketu:

15G/50G

Tip zastaranja:

Prescription

Povzetek izdelek:

Active ingredient group (AIG) number: 0252502003; AHFS:

Status dovoljenje:

APPROVED

Datum dovoljenje:

2022-04-08

Lastnosti izdelka

Page 1 of 40
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
PRZ-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
PHARMARIS CANADA INC.
8310-130 Street, Suite 102,
Surrey, British Columbia,
Canada V3W 8J9
Date of Initial Authorization:
April 06, 2022
Submission Control No: 228559
Page 2 of 40
RECENT MAJOR LABEL CHANGES
None at the time of authorization.
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.................................................... 4
4
DOSAGE AND ADMINISTRATION
............................................................................
5
4.1
Dosing
Considerations.....................................................................................
5
4.2
Recommended Dose and Dosage Adjustment Replacement Therapy
............. 5
4.3
Reconstitution
..................................................................................................
7
4.4
Administration
..................................................................................................
7
4.5
Missed Dose
....................................................................................................
7
5
OVERDOSAGE
...........................................................................................................
7
6
DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING
.....