AREDIA 30MG POWDER FOR SOLUTION

País: Canadà

Idioma: anglès

Font: Health Canada

ingredients actius:

PAMIDRONATE DISODIUM

Disponible des:

NOVARTIS PHARMACEUTICALS CANADA INC

Codi ATC:

M05BA03

Designació comuna internacional (DCI):

PAMIDRONIC ACID

Dosis:

30MG

formulario farmacéutico:

POWDER FOR SOLUTION

Composición:

PAMIDRONATE DISODIUM 30MG

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: 0123608004; AHFS:

Estat d'Autorització:

CANCELLED POST MARKET

Data d'autorització:

2016-02-23

Fitxa tècnica

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_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
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_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
..................................................................