RASILEZ HCT TABLET

Země: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktivní složka:

ALISKIREN (ALISKIREN FUMARATE); HYDROCHLOROTHIAZIDE

Dostupné s:

NODEN PHARMA DAC

ATC kód:

C09XA52

INN (Mezinárodní Name):

ALISKIREN AND HYDROCHLOROTHIAZIDE

Dávkování:

300MG; 12.5MG

Léková forma:

TABLET

Složení:

ALISKIREN (ALISKIREN FUMARATE) 300MG; HYDROCHLOROTHIAZIDE 12.5MG

Podání:

ORAL

Jednotky v balení:

28

Druh předpisu:

Prescription

Terapeutické oblasti:

RENIN INHIBITORS

Přehled produktů:

Active ingredient group (AIG) number: 0252648003; AHFS:

Stav Autorizace:

CANCELLED POST MARKET

Datum autorizace:

2020-02-11

Charakteristika produktu

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PRODUCT MONOGRAPH
PR
RASILEZ HCT
®
ALISKIREN (AS ALISKIREN FUMARATE) & HYDROCHLOROTHIAZIDE TABLETS
150 mg/12.5 mg, 150 mg/25 mg, 300 mg/12.5 mg and 300 mg /25 mg
Renin inhibitor and diuretic
Noden Pharma DAC
D'Olier Chambers, 16A D'Olier Street, Dublin 2, Ireland
Date of Preparation:
September 2, 2009
Date of revision:
August 7, 2019
Control No. 228128
®
RASILEZ HCT is a Registered trademark
_ _
_Page 2 of 46_
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
................................................................................................11
DRUG INTERACTIONS
................................................................................................17
DOSAGE AND ADMINISTRATION
...........................................................................25
OVERDOSAGE
...............................................................................................................26
ACTION AND CLINICAL PHARMACOLOGY
........................................................26
STORAGE AND
STABILITY........................................................................................31
DOSAGE FORMS, COMPOSITION AND PACKAGING
........................................31
PART II: SCIENTIFIC INFORMATION
...............................................................................33
PHARMACEUTICAL INFORMATION
......................................................................33
CLINICAL TRIALS
.......................................................................................