PAMIDRONATE DISODIUM FOR INJECTION POWDER FOR SOLUTION

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

PAMIDRONATE DISODIUM

Tersedia dari:

SANDOZ CANADA INCORPORATED

Kode ATC:

M05BA03

INN (Nama Internasional):

PAMIDRONIC ACID

Dosis:

90MG

Bentuk farmasi:

POWDER FOR SOLUTION

Komposisi:

PAMIDRONATE DISODIUM 90MG

Rute administrasi :

INTRAVENOUS

Unit dalam paket:

100

Jenis Resep:

Prescription

Area terapi:

BONE RESORPTION INHIBITORS

Ringkasan produk:

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

Status otorisasi:

CANCELLED PRE MARKET

Tanggal Otorisasi:

2017-05-26

Karakteristik produk

Product Monograph
Pr
Pamidronate Disodium for Injection
30 mg, 90 mg
For I.V. infusion only
Bone Metabolism Regulator
Sandoz Canada Inc.
145 Jules-Léger
Boucherville (Québec) J4B 7K8
Date of Preparation:
April 1, 2005
Control#: 097809
- 2 -
Product Monograph
Name of Drug
Pr
Pamidronate Disodium for Injection
30 mg, 90 mg
For I.V. infusion only
Therapeutic Classification
Bone Metabolism Regulator
Actions and Clinical Pharmacology
Pamidronate disodium belongs to a class of bisphosphonates (previously
termed
diphosphonate),
which
inhibit
bone
resorption.
The
therapeutic
activity
of
pamidronate disodium 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 pamidronate disodium 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
- 3 -
suppresses
the
migration
of
osteoclast
precursors
onto
the
bone
and
their
subsequent transformation into the mature resorbing osteoclast.
Tumour-induced hypercalcemia
In tumour-induced hypercalcemia, pamidronate disodium 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.
Pamidronate disodium 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
osteolysis, renal dysfunction contributes to the pathogenesis of
t