VALSARTAN-HCTZ TABLET

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

HYDROCHLOROTHIAZIDE; VALSARTAN

Commercializzato da:

PRO DOC LIMITEE

Codice ATC:

C09DA03

INN (Nome Internazionale):

VALSARTAN AND DIURETICS

Dosaggio:

25MG; 320MG

Forma farmaceutica:

TABLET

Composizione:

HYDROCHLOROTHIAZIDE 25MG; VALSARTAN 320MG

Via di somministrazione:

ORAL

Confezione:

100

Tipo di ricetta:

Prescription

Dettagli prodotto:

Active ingredient group (AIG) number: 0240204005; AHFS:

Stato dell'autorizzazione:

APPROVED

Data dell'autorizzazione:

2022-01-13

Scheda tecnica

_Valsartan-HCTZ _
_Page 1 of 41 _
PRODUCT MONOGRAPH
PR VALSARTAN-HCTZ
valsartan and hydrochlorothiazide tablets
80mg/12.5mg, 160mg/12.5mg, 160 mg/25 mg,
320mg/12.5mg and 320mg/25mg tablets
Manufacturer’s Standard
Angiotensin II AT
1
Receptor Blocker and Diuretic
PRO DOC LTÉE
2925 boul. Industriel
Laval, Quebec
H7L 3W9
Date of Revision:
January 10, 2022
Submission Control No.: 259434
_Valsartan-HCTZ _
_Page 2 of 41 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
..................................................................................................10
DRUG INTERACTIONS
..................................................................................................14
DOSAGE AND ADMINISTRATION
..............................................................................17
OVERDOSAGE
................................................................................................................20
ACTION AND CLINICAL PHARMACOLOGY
............................................................20
STORAGE AND STABILITY
..........................................................................................24
SPECIAL HANDLING INSTRUCTIONS
.......................................................................24
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................24
PART II: SCIENTIFIC INFORMATION
...............................................................................26
PHARMACEUTICAL INFORMATION
......................................................