ATORVASTATIN TABLET

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

ATORVASTATIN (ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE)

Disponible desde:

APOTEX INC

Código ATC:

C10AA05

Designación común internacional (DCI):

ATORVASTATIN

Dosis:

80MG

formulario farmacéutico:

TABLET

Composición:

ATORVASTATIN (ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE) 80MG

Vía de administración:

ORAL

Unidades en paquete:

250ML

tipo de receta:

Prescription

Área terapéutica:

HMG-COA REDUCTASE INHIBITORS

Resumen del producto:

Active ingredient group (AIG) number: 0133055004; AHFS:

Estado de Autorización:

MARKETED

Fecha de autorización:

2013-01-07

Ficha técnica

Page 1 of 46
PRODUCT MONOGRAPH
Pr
ATORVASTATIN
(ATORVASTATIN CALCIUM TABLETS)
10 MG, 20 MG, 40 MG AND 80 MG
(ATORVASTATIN AS ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE)
LIPID METABOLISM REGULATOR
APOTEX INC.
DATE OF PREPARATION:
150 SIGNET DRIVE
NOVEMBER 5, 2012
TORONTO, ONTARIO
M9L 1T9
SUBMISSION CONTROL NO: 159558
Page 2 of 46
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.....................................................................
3
SUMMARY PRODUCT INFORMATION
...........................................................................................
3
INDICATIONS AND CLINICAL USE
.................................................................................................
3
CONTRAINDICATIONS
......................................................................................................................
4
WARNINGS AND PRECAUTIONS
.....................................................................................................
5
ADVERSE REACTIONS
......................................................................................................................
9
DRUG INTERACTIONS
.....................................................................................................................
12
DOSAGE AND ADMINISTRATION
.................................................................................................
16
OVERDOSAGE
...................................................................................................................................
17
ACTION AND CLINICAL PHARMACOLOGY
...............................................................................
18
STORAGE AND STABILITY
.............................................................................................................
20
SPECIAL HANDLING INSTRUCTIONS
..........................................................................................
20
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................................ 21
PART II: SCIENTIFIC INFORMATION