MYLAN-TELMISARTAN HCTZ TABLET

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

TELMISARTAN; HYDROCHLOROTHIAZIDE

Commercializzato da:

MYLAN PHARMACEUTICALS ULC

Codice ATC:

C09DA07

INN (Nome Internazionale):

TELMISARTAN AND DIURETICS

Dosaggio:

80MG; 12.5MG

Forma farmaceutica:

TABLET

Composizione:

TELMISARTAN 80MG; HYDROCHLOROTHIAZIDE 12.5MG

Via di somministrazione:

ORAL

Confezione:

28/100/500

Tipo di ricetta:

Prescription

Area terapeutica:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

Dettagli prodotto:

Active ingredient group (AIG) number: 0244783001; AHFS:

Stato dell'autorizzazione:

CANCELLED POST MARKET

Data dell'autorizzazione:

2017-05-08

Scheda tecnica

1
_ _
PRODUCT MONOGRAPH
PR
MYLAN-TELMISARTAN HCTZ
Telmisartan/Hydrochlorothiazide Tablets
80/12.5 mg and 80/25 mg
Angiotensin II AT
1
Receptor Blocker/Diuretic
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke, ON
M8Z 2S6
Submission Control No.: 162850
Date of Revision: July 17, 2013
2
_ _
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
.........................................................................................................
21
DOSAGE AND ADMINISTRATION
.....................................................................................
27
OVERDOSAGE
.......................................................................................................................
28
ACTION AND CLINICAL PHARMACOLOGY
................................................................... 29
STORAGE AND STABILITY
.................................................................................................
35
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 35
PART II: SCIENTIFIC INFORMATION
.........................................................................
36
PHARMACEUTICAL INFORMATION
.................................................................................
36
CLINICAL TRIALS
.............................................................................................................