MYLAN-TELMISARTAN HCTZ TABLET
País: Canadà
Idioma: anglès
Font: Health Canada
Fitxa tècnica
(SPC)
17-07-2013
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ingredients actius:
TELMISARTAN; HYDROCHLOROTHIAZIDE
Disponible des:
MYLAN PHARMACEUTICALS ULC
Codi ATC:
C09DA07
Designació comuna internacional (DCI):
TELMISARTAN AND DIURETICS
Dosis:
80MG; 12.5MG
formulario farmacéutico:
TABLET
Composición:
TELMISARTAN 80MG; HYDROCHLOROTHIAZIDE 12.5MG
Vía de administración:
ORAL
Unidades en paquete:
28/100/500
tipo de receta:
Prescription
Área terapéutica:
ANGIOTENSIN II RECEPTOR ANTAGONISTS
Resumen del producto:
Active ingredient group (AIG) number: 0244783001; AHFS:
Estat d'Autorització:
CANCELLED POST MARKET
Data d'autorització:
2017-05-08
Fitxa tècnica
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
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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
.............................................................................................................
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