AREDIA POWDER FOR SOLUTION

Land: Kanada

Sprache: Englisch

Quelle: Health Canada

Wirkstoff:

PAMIDRONATE DISODIUM

Verfügbar ab:

NOVARTIS PHARMACEUTICALS CANADA INC

ATC-Code:

M05BA03

INN (Internationale Bezeichnung):

PAMIDRONIC ACID

Dosierung:

60MG

Darreichungsform:

POWDER FOR SOLUTION

Zusammensetzung:

PAMIDRONATE DISODIUM 60MG

Verabreichungsweg:

INTRAVENOUS

Einheiten im Paket:

1

Verschreibungstyp:

Prescription

Therapiebereich:

BONE RESORPTION INHIBITORS

Produktbesonderheiten:

Active ingredient group (AIG) number: 0123608003; AHFS:

Berechtigungsstatus:

CANCELLED POST MARKET

Berechtigungsdatum:

2001-07-30

Fachinformation

Product Monograph
Pr
AREDIA*
(pamidronate disodium for injection)
30 mg, 60 mg, 90 mg
For I.V. infusion only
Bone Metabolism Regulator
Novartis Pharmaceuticals Canada Inc.
Dorval, Québec H9S 1A9
Date of Preparation:
February 24, 1993
Control No.: 094193
Date of Revision:
January 7, 2005
Pr
AREDIA* is a registered trademark
- 2 -
Product Monograph
Name of Drug
Pr
AREDIA*
(pamidronate disodium for injection)
30 mg, 60 mg, 90 mg
For I.V. infusion only
Therapeutic Classification
Bone Metabolism Regulator
Actions and Clinical Pharmacology
AREDIA (pamidronate disodium) belongs to a class of bisphosphonates
(previously termed
diphosphonate), which inhibit bone resorption. The therapeutic
activity of AREDIA is
attributable to its potent anti-osteoclastic activity on bone. In
animal studies, at therapeutic
doses, pamidronate disodium inhibits bone resorption apparently
without inhibiting bone
formation and mineralization.
The predominant means by which AREDIA reduces bone turnover both _in
vitro_ and _in vivo_
appears to be through the local, direct antiresorptive effect of
bone-bound bisphosphonate.
Pamidronate disodium binds to calcium phosphate (hydroxyapatite)
crystals and directly
inhibits the formation and dissolution of this bone mineral component
_in vitro_. _In vitro_ studies
indicate that pamidronate disodium is a potent inhibitor of
osteoclastic bone resorption.
Pamidronate disodium also suppresses the migration of osteoclast
precursors onto the bone
and their subsequent transformation into the mature resorbing
osteoclast.
- 3 -
Tumour-induced hypercalcemia
In tumour-induced hypercalcemia, AREDIA normalizes plasma calcium
between 3 and 7 days
following the initiation of treatment irrespective of the type of
malignancy or presence of
detectable metastases. This effect is dependent on initial calcium
levels.
AREDIA improves symptoms associated with hypercalcemia, e.g. anorexia,
nausea, vomiting
and diminished mental status.
The kidneys play a prominent role in calcium homeostasis. In addition
to skeletal osteoly