Pamidronate Mylan (Pamidronate Disodium Injection 3mgml)

Valsts: Malaizija

Valoda: angļu

Klimata pārmaiņas: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Aktīvā sastāvdaļa:

Disodium Pamidronate

Pieejams no:

UNIMED SDN BHD

SNN (starptautisko nepatentēto nosaukumu):

Disodium Pamidronate

Vienības iepakojumā:

10ml1Units mL

Ražojis:

Mylan Laboratories Limited

Produkta apraksts

PAMIDRONATE MYLAN
PAMIDRONATE DISODIUM INJECTION 3MG/ML
PRODUCT DESCRIPTION:
Clear colorless solution free from visible particles.
COMPOSITION:
Each mL contains Pamidronate Disodium 3mg/mL.
PHARMACOLOGY:
Pamidronate Disodium is a potent inhibitor of osteoclastic bone
resorption. It binds strongly to
hydroxyapatite crystals and inhibits the formation and dissolution of
these crystals _in vitro_. Inhibition
of osteoclastic bone resorption in vivo may be at least partly due to
binding of the drug to be bone
mineral.
Pamidronate Disodium suppresses the accession of osteoclastic
precursors on to the bone and their
subsequent transformation into the mature, resorbing osteoclasts.
However, the local and direct
antiresorptive effect of bone-bound bisphosphonate appears to be the
predominant mode of action
in vitro and in vivo.
Experimental studies have demonstrated that Pamidronate Disodium
inhibits tumour induced
osteolysis when given prior to or at the time of inoculation or
transplantation with tumour cells.
Biochemical changes reflecting the inhibitory effect of Pamidronate
Disodium on tumour induced
hypercalcaemia, are characterized by a decrease in serum calcium and
phosphate and secondarily by
decrease in urinary excretion of calcium, phosphate and
hydroxyproline.
PHARMACOKINETICS
GENERAL CHARACTERISTICS
Pamidronate Disodium has a strong affinity for calcified tissues and
total elimination of Pamidronate
Disodium from the body is not observed within the time frame of
experimental studies. Calcified
tissues are, therefore, regarded as site of apparent elimination.
ABSORPTION
Pamidronate Disodium is given by IV infusion. By definition,
absorption is complete at the end of the
infusion.
DISTRIBUTION
Plasma concentrations of Pamidronate Disodium rise rapidly after the
start of an infusion
and fall rapidly when the infusion is stopped. The apparent half-life
in plasma is about
0.8 hr. Apparent steady-state concentrations are therefore achieved
with infusions of
more than about 2-3 hrs duration. Peak plasma Pamidronate