APO-VALSARTAN TABLET
País: Canadà
Idioma: anglès
Font: Health Canada
Fitxa tècnica
(SPC)
01-10-2015
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ingredients actius:
VALSARTAN
Disponible des:
APOTEX INC
Codi ATC:
C09CA03
Designació comuna internacional (DCI):
VALSARTAN
Dosis:
80MG
formulario farmacéutico:
TABLET
Composición:
VALSARTAN 80MG
Vía de administración:
ORAL
Unidades en paquete:
30
tipo de receta:
Prescription
Área terapéutica:
ANGIOTENSIN II RECEPTOR ANTAGONISTS
Resumen del producto:
Active ingredient group (AIG) number: 0131885001; AHFS:
Estat d'Autorització:
MARKETED
Data d'autorització:
2012-07-12
Fitxa tècnica
_APO-VALSARTAN Tablets Product Monograph_
_ _Page 1 of 41
PRODUCT MONOGRAPH
PR
APO-VALSARTAN
(VALSARTAN)
40 MG, 80 MG, 160 MG AND 320 MG TABLETS
Angiotensin II AT
1
Receptor Blocker
APOTEX INC. DATE OF REVISION:
150 SIGNET DRIVE SEPTEMBER 16, 2015
TORONTO, ONTARIO
M9L 1T9
CONTROL NUMBER: 187072
_APO-VALSARTAN Tablets Product Monograph_
_ _Page 2 of 41
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.............................................................. 3
SUMMARY PRODUCT INFORMATION
...............................................................................
3
INDICATIONS AND CLINICAL USE
.....................................................................................
3
CONTRAINDICATIONS
.......................................................................................................
4
WARNINGS AND PRECAUTION
.........................................................................................
4
ADVERSE REACTIONS
......................................................................................................
8
DRUG INTERACTIONS
......................................................................................................12
DOSAGE AND ADMINISTRATION
.....................................................................................14
OVERDOSAGE
...................................................................................................................16
ACTION AND CLINICAL PHARMACOLOGY
......................................................................16
STORAGE AND
STABILITY................................................................................................19
SPECIAL HANDLING INSTRUCTIONS
..............................................................................19
DOSAGE FORMS, COMPOSITION AND PACKAGING
......................................................19
PART II: SCIENTIFIC INFORMATION
....................................................................................21
PHARMACEUTICAL INFORMATION
...................................
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