NTP-TELMISARTAN HCTZ TABLET

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

TELMISARTAN (TELMISARTAN SODIUM); HYDROCHLOROTHIAZIDE

Dostępny od:

TEVA CANADA LIMITED

Kod ATC:

C09DA07

INN (International Nazwa):

TELMISARTAN AND DIURETICS

Dawkowanie:

80.0MG; 25.0MG

Forma farmaceutyczna:

TABLET

Skład:

TELMISARTAN (TELMISARTAN SODIUM) 80.0MG; HYDROCHLOROTHIAZIDE 25.0MG

Droga podania:

ORAL

Sztuk w opakowaniu:

30/100/500

Typ recepty:

Prescription

Dziedzina terapeutyczna:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

Podsumowanie produktu:

Active ingredient group (AIG) number: 0244783002; AHFS:

Status autoryzacji:

CANCELLED PRE MARKET

Data autoryzacji:

2017-06-13

Charakterystyka produktu

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_NTP-TELMISARTAN HCTZ _
_Page 1 of 50_
PRODUCT MONOGRAPH
PR
NTP-TELMISARTAN HCTZ
Telmisartan (as Telmisartan Sodium) and Hydrochlorothiazide Tablets
80 mg/12.5 mg and 80 mg/25 mg
NTP standard
Angiotensin II AT
1
Receptor Blocker/Diuretic
Teva Canada Ltd.
30 Novopharm Court
Toronto, Ontario
Canada, M1B 2K9
Date of Preparation:
September 23, 2013
Submission Control No: 167610
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_NTP-TELMISARTAN HCTZ _
_Page 2 of 50_
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
...................................................................................................
9
DRUG INTERACTIONS
.................................................................................................
20
DOSAGE AND ADMINISTRATION
.............................................................................
23
OVERDOSAGE
...............................................................................................................
25
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 25
STORAGE AND STABILITY
.........................................................................................
31
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 31
PART II: SCIENTIFIC INFORMATION
..............................................................................
32
PHARMACEUTICAL INFORMATION
.........................................................................
32
CLINICAL TRIALS
...............................................................