Q-VALSARTAN HCTZ TABLET

Riik: Kanada

keel: inglise

Allikas: Health Canada

Toimeaine:

VALSARTAN; HYDROCHLOROTHIAZIDE

Saadav alates:

QD PHARMACEUTICALS ULC

ATC kood:

C09DA03

INN (Rahvusvaheline Nimetus):

VALSARTAN AND DIURETICS

Annus:

320MG; 25MG

Ravimvorm:

TABLET

Koostis:

VALSARTAN 320MG; HYDROCHLOROTHIAZIDE 25MG

Manustamisviis:

ORAL

Ühikuid pakis:

30/100

Retsepti tüüp:

Prescription

Terapeutiline ala:

ANGIOTENSIN-CONVERTING ENZYME INHIBITORS

Toote kokkuvõte:

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

Volitamisolek:

CANCELLED PRE MARKET

Loa andmise kuupäev:

2015-08-21

Toote omadused

PRODUCT MONOGRAPH
PR
Q-VALSARTAN HCTZ
Valsartan and Hydrochlorothiazide Tablets
80 mg/12.5 mg, 160 mg/12.5 mg, 160 mg/25 mg,
320 mg/12.5 mg and 320 mg/25 mg
USP
Angiotensin II AT
1
Receptor Blocker and Diuretic
QD Pharmaceuticals ULC
85 Advance Road
Etobicoke, ON
M8Z 2S6
Submission Control No.: 177603
Date of Revision: September 12, 2014
2
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
............................................. 3
SUMMARY PRODUCT INFORMATION
................................................................ 3
INDICATIONS AND CLINICAL USE
......................................................................
4
CONTRAINDICATIONS
............................................................................................
4
WARNINGS AND PRECAUTIONS
..........................................................................
5
ADVERSE REACTIONS
...........................................................................................
11
DRUG INTERACTIONS
.............................................................................................
15
DOSAGE AND ADMINISTRATION
......................................................................
20
OVERDOSAGE
..........................................................................................................
22
ACTION AND CLINICAL PHARMACOLOGY
................................................... 23
STORAGE AND STABILITY
..................................................................................
27
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................... 27
PART II: SCIENTIFIC INFORMATION ................................................................ 30
PHARMACEUTICAL INFORMATION
................................................................. 30
CLINICAL TRIALS
...................................................................................................
31
DETAILED PHARMACOLOGY
.............................................................................
33
TOXICOLOGY
...................................