APO-NEBIVOLOL TABLET

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

NEBIVOLOL (NEBIVOLOL HYDROCHLORIDE)

Disponible desde:

APOTEX INC

Código ATC:

C07AB12

Designación común internacional (DCI):

NEBIVOLOL

Dosis:

20MG

formulario farmacéutico:

TABLET

Composición:

NEBIVOLOL (NEBIVOLOL HYDROCHLORIDE) 20MG

Vía de administración:

ORAL

Unidades en paquete:

100

tipo de receta:

Prescription

Área terapéutica:

BETA-ADRENERGIC BLOCKING AGENTS

Resumen del producto:

Active ingredient group (AIG) number: 0153531004; AHFS:

Estado de Autorización:

APPROVED

Fecha de autorización:

2020-12-22

Ficha técnica

Page 1 of 34
PRODUCT MONOGRAPH
PR
APO-NEBIVOLOL
Nebivolol Tablets
2.5 mg, 5 mg and 20 mg Nebivolol
(as nebivolol hydrochloride)
Antihypertensive Agent
APOTEX INC.
Date of Preparation:
150 Signet Drive
September 23, 2019
Toronto, Ontario
M9L 1T9
Submission Control No: 223530
Page 2 of 34
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.................................................................................
3
SUMMARY PRODUCT INFORMATION
.......................................................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................................................
3
CONTRAINDICATIONS
..................................................................................................................................
3
WARNINGS AND PRECAUTIONS
.................................................................................................................
4
ADVERSE REACTIONS
..................................................................................................................................
7
DRUG INTERACTIONS
.................................................................................................................................
11
DOSAGE AND ADMINISTRATION
.............................................................................................................
13
OVERDOSAGE
...............................................................................................................................................
14
ACTION AND CLINICAL PHARMACOLOGY
...........................................................................................
15
STORAGE AND
STABILITY.........................................................................................................................
18
SPECIAL HANDLING INSTRUCTIONS
......................................................................................................
18
DOSAGE FORMS, COMPOSITION AND PACKAGING
..