PAMIDRONATE DISODIUM FOR INJECTION POWDER FOR SOLUTION

国: カナダ

言語: 英語

ソース: Health Canada

有効成分:

PAMIDRONATE DISODIUM

から入手可能:

SANDOZ CANADA INCORPORATED

ATCコード:

M05BA03

INN（国際名）:

PAMIDRONIC ACID

投薬量:

30MG

医薬品形態:

POWDER FOR SOLUTION

構図:

PAMIDRONATE DISODIUM 30MG

投与経路:

INTRAVENOUS

パッケージ内のユニット:

100

処方タイプ:

Prescription

治療領域:

BONE RESORPTION INHIBITORS

製品概要:

Active ingredient group (AIG) number: 0123608004; AHFS:

認証ステータス:

CANCELLED PRE MARKET

承認日:

2017-05-26

製品の特徴

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