AREDIA 90MG POWDER FOR SOLUTION

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

PAMIDRONATE DISODIUM

Disponible desde:

NOVARTIS PHARMACEUTICALS CANADA INC

Código ATC:

M05BA03

Designación común internacional (DCI):

PAMIDRONIC ACID

Dosis:

90MG

formulario farmacéutico:

POWDER FOR SOLUTION

Composición:

PAMIDRONATE DISODIUM 90MG

Vía de administración:

INTRAVENOUS

Unidades en paquete:

10ML

tipo de receta:

Prescription

Área terapéutica:

BONE RESORPTION INHIBITORS

Resumen del producto:

Active ingredient group (AIG) number: 0123608002; AHFS:

Estado de Autorización:

MARKETED

Fecha de autorización:

1999-07-19

Ficha técnica

_ _
_ _
_Page 1 of 38_
PRODUCT MONOGRAPH
PR
AREDIA
®
(pamidronate disodium for injection)
30 mg, 90 mg
For i.v. infusion only
Bone Metabolism Regulator
Novartis Pharmaceuticals Canada Inc.
Dorval, Quebec, H9S 1A9
Date of Revision:
April 17, 2014
Control No.: 172078
_ _
_ _
_Page 2 of 38_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................3
WARNINGS AND PRECAUTIONS
..................................................................................3
ADVERSE REACTIONS
....................................................................................................9
DRUG INTERACTIONS
..................................................................................................13
DOSAGE AND ADMINISTRATION
..............................................................................14
OVERDOSAGE
................................................................................................................18
ACTION AND CLINICAL PHARMACOLOGY
............................................................18
STORAGE AND STABILITY
..........................................................................................22
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................22
PART II: SCIENTIFIC INFORMATION
...............................................................................23
PHARMACEUTICAL INFORMATION
..........................................................................23
CLINICAL TRIALS
..........................................................................................................23
DETAILED PHARMACOLOGY
..................................................................