MYLAN-CILAZAPRIL TABLET

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

CILAZAPRIL (CILAZAPRIL MONOHYDRATE)

Disponible desde:

MYLAN PHARMACEUTICALS ULC

Código ATC:

C09AA08

Designación común internacional (DCI):

CILAZAPRIL

Dosis:

2.5MG

formulario farmacéutico:

TABLET

Composición:

CILAZAPRIL (CILAZAPRIL MONOHYDRATE) 2.5MG

Vía de administración:

ORAL

Unidades en paquete:

100

tipo de receta:

Prescription

Área terapéutica:

ANGIOTENSIN-CONVERTING ENZYME INHIBITORS

Resumen del producto:

Active ingredient group (AIG) number: 0122806004; AHFS:

Estado de Autorización:

APPROVED

Fecha de autorización:

2009-07-10

Ficha técnica

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_Page 1_
PRODUCT MONOGRAPH
PR MYLAN-CILAZAPRIL
Cilazapril
Monohydrate Tablets
1 mg, 2.5 mg, 5 mg
Angiotensin Converting Enzyme Inhibitor
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke, ON
M8Z 2S6
Submission
Control No.: 257402
Date of Revision:
November 16, 2021
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_Page 2_
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............................................................................................12
DRUG INTERACTIONS
............................................................................................19
DOSAGE AND ADMINISTRATION
.........................................................................23
OVERDOSAGE
.........................................................................................................26
ACTION AND CLINICAL
PHARMACOLOGY.........................................................27
STORAGE AND STABILITY
....................................................................................30
SPECIAL HANDLING INSTRUCTIONS
...................................................................30
DOSAGE FORMS, COMPOSITION AND PACKAGING
..........................................30
PART II: SCIENTIFIC INFORMATION
..........................................................................
32
PHARMACEUTICAL INFORMATION
.....................................................................32
CLINICAL TRIALS
...................................................................................................33
DETAILED
PHARMACOLOGY..........................................