NTP-IRBESARTAN/HCTZ TABLET
Krajina: Kanada
Jazyk: angličtina
Zdroj: Health Canada
Súhrn charakteristických
(SPC)
12-09-2013
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Aktívna zložka:
IRBESARTAN; HYDROCHLOROTHIAZIDE
Dostupné z:
TEVA CANADA LIMITED
ATC kód:
C09DA04
INN (Medzinárodný Name):
IRBESARTAN AND DIURETICS
Dávkovanie:
150MG; 12.5MG
Forma lieku:
TABLET
Zloženie:
IRBESARTAN 150MG; HYDROCHLOROTHIAZIDE 12.5MG
Spôsob podávania:
ORAL
Počet v balení:
100
Typ predpisu:
Prescription
Terapeutické oblasti:
ANGIOTENSIN II RECEPTOR ANTAGONISTS
Prehľad produktov:
Active ingredient group (AIG) number: 0240086001; AHFS:
Stav Autorizácia:
CANCELLED PRE MARKET
Dátum Autorizácia:
2015-08-06
Súhrn charakteristických
PRODUCT MONOGRAPH
PR
NTP-IRBESARTAN/HCTZ
(irbesartan/hydrochlorothiazide)
tablets 150/12.5 mg, 300/12.5 mg and 300/25 mg
Manufacturer’s Standard
Angiotensin II AT
1
Receptor Blocker / Diuretic
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
Canada, M1B 2K9
Submission Control No: 167244
Date of Preparation:
September 4, 2013
2
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT INFORMATION
...............................................................................
3
INDICATIONS AND CLINICAL USE
.....................................................................................
3
CONTRAINDICATIONS
..........................................................................................................
3
WARNINGS AND PRECAUTIONS
.........................................................................................
4
ADVERSE REACTIONS
...........................................................................................................
7
DOSAGE AND ADMINISTRATION
.....................................................................................
14
OVERDOSAGE
.......................................................................................................................
16
ACTION AND CLINICAL PHARMACOLOGY
................................................................... 16
STORAGE AND STABILITY
.................................................................................................
20
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 20
PART II: SCIENTIFIC INFORMATION
...............................................................................
21
PHARMACEUTICAL INFORMATION
.................................................................................
21
CLINICAL TRIALS
.................................................................................................................
22
DETAILED PHARMACOLOGY
.......................................
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