AVA-VALSARTAN HCT TABLET

Land: Kanada

Tungumál: enska

Heimild: Health Canada

Virkt innihaldsefni:

VALSARTAN; HYDROCHLOROTHIAZIDE

Fáanlegur frá:

AVANSTRA INC

ATC númer:

C09DA03

INN (Alþjóðlegt nafn):

VALSARTAN AND DIURETICS

Skammtar:

320MG; 12.5MG

Lyfjaform:

TABLET

Samsetning:

VALSARTAN 320MG; HYDROCHLOROTHIAZIDE 12.5MG

Stjórnsýsluleið:

ORAL

Einingar í pakka:

30

Gerð lyfseðils:

Prescription

Lækningarsvæði:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

Vörulýsing:

Active ingredient group (AIG) number: 0240204004; AHFS:

Leyfisstaða:

CANCELLED POST MARKET

Leyfisdagur:

2014-08-21

Vara einkenni

_Ava-Valsartan HCT _
_Page 1 of 34 _
PRODUCT MONOGRAPH
PR
AVA-VALSARTAN HCT
(VALSARTAN AND HYDROCHLOROTHIAZIDE TABLETS)
80MG/12.5MG, 160MG/12.5MG, 160 MG/25 MG,
320MG/12.5MG AND 320MG/25MG TABLETS
Angiotensin II AT
1
Receptor Blocker and Diuretic
Avanstra Inc.
Date of Revision: June 12, 2012
10761-25
th
street NE, Suite 110,
Calgary, Alberta, Canada
T3N 0A4
Submission Control No: 155873
_Ava-Valsartan HCT _
_Page 2 of 34 _
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
....................................................................................................8
DRUG INTERACTIONS
..................................................................................................12
DOSAGE AND ADMINISTRATION
..............................................................................15
OVERDOSAGE
................................................................................................................16
ACTION AND CLINICAL PHARMACOLOGY
............................................................17
STORAGE AND STABILITY
..........................................................................................20
SPECIAL HANDLING INSTRUCTIONS
.......................................................................21
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................21
PART II: SCIENTIFIC INFORMATION
...............................................................................23
PHARMACEUTICAL INFORMATION
.................................................