Stritoxol Paclitaxel Concentrate For Solution For Infusion 6 mg mL

Land: Malaysia

Sprog: engelsk

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

Aktiv bestanddel:

PACLITAXEL

Tilgængelig fra:

MYLAN HEALTHCARE SDN. BHD.

INN (International Name):

PACLITAXEL

Enheder i pakken:

5ml mL; 16.7ml mL; 50ml mL

Fremstillet af:

Mylan Laboratories Limited (OTL)

Produktets egenskaber

COMPOSITION:
Each mL contains Paclitaxel 6 mg.
PRODUCT DESCRIPTION:
Clear, colorless to slightly yellow viscous solution free from visible
particles.
PHARMACOLOGY:
Paclitaxel
is
an
antimicrotubule
antineoplastic
agent.
It
promotes
microtubule
assembly by enhancing the polymerisation of tubulin, the protein
subunit of spindle
microtubules even in the absence of the mediators normally required
for microtubule
assembly (eg, guanosine triphosphate [GTP]) thereby inducing the
formation of stable,
non-functional microtubules. While the precise mechanism of action of
the drug is not
completely known, paclitaxel disrupts the dynamic equilibrium within
the microtubule
system and blocks cells in the late G2 phase and M phase of the cell
cycle, inhibitting
cell replicaton and impairing function of nervous tissue.
PHARMACOKINETICS
Following intravenous administration, Paclitaxel exhibits a biphasic
decline in plasma
concentrations. The 1
st
phase shows rapid decline representing distribution of
Paclitaxel to the peripheral compartment and elimination. This initial
phase is followed
by a relatively slow elimination of Paclitaxel from the peripheral
compartment.
The following ranges for the pharmacokinetic parameters have been
determined in
patients given doses of 135 and 175 mg/m
2
as 3- and 24-hr infusions of Paclitaxel:
Mean terminal half-life: 3-52.7 hrs; total body clearance: 11.6-24
L/hr/m
2
; mean
steady-state volume of distribution: 198-688 L/m
2
.
These indicate extensive distribution of Paclitaxel outside the
vascular system and/
or tissue binding.
The following mean values for the pharmacokinetic have been reported
following a
3-hr infusion of 175 mg/m
2
Paclitaxel: Mean terminal half-life: 9.9 hrs; mean total
body clearance: 12.4 L/hr/m
2
.
The serum protein-binding of paclitaxel is 89%.
The liver is thought to be the primary site of metabolism for
Paclitaxel. The mean
cumulative urinary recovery of unchanged Pactitaxel has been reported
as 1.8-12.6%
of the dose.
INDICATIONS:
Paclitaxel is indicated in the primary