UNITAXEL Inj. 100mg16.67mL Concentrate for Solution for Infusion

Pays: Malaisie

Langue: anglais

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

Ingrédients actifs:

Paclitaxel USP

Disponible depuis:

Eucogen Pharma Sdn. Bhd.

DCI (Dénomination commune internationale):

Paclitaxel USP

Unités en paquet:

1 vials x 16.67 ml

Fabriqué par:

Korea United Pharm. Inc.

Notice patient

Not applicable

Résumé des caractéristiques du produit

UNITAXEL INJ. 100 MG/ 16.67 ML
CONCENTRATE FOR SOLUTION
FOR INFUSION
Paclitaxel 100 mg
ROUTE OF ADMINISTRATION : For Intravenous use
COMPOSITION
Each vial (16.67 mL) contains
Paclitaxel
‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥‥
100 mg
Excipients :
Povidone, Polyoxyl 35 Caster Oil, Polysorbate 80, Polyethylene Glycol
400, Malic Acid, Dehadrated Alcohol
DESCRIPTION
After opening before dilution : Colorless to pale yellow viscous
liquid in an amber vial
After dilution : Colorless to pale yellow viscous liquid
PHARMACODYNAMICS
Paclitaxel is an antimicrotubule agent that promotes the assembly of
microtubules from tubulin dimers and
stabilises microtubules by preventing depolymerization. This stability
results in the inhibition of the normal
dynamic reorganisation of the microtubule network that is essential
for vital interphase and mitotic cellular
functions. In addition, paclitaxel induces abnormal arrays or bundles
of microtubules throughout the cell cycle and
multiple asters of microtubules during mitosis.
PHARMACOKINETICS
Following intravenous administration, paclitaxel exhibits a biphasic
decline in plasma concentrations. The
pharmacokinetics of paclitaxel were determined following 3 and 24 hour
infusions at doses of 135 and 175 mg/m
2
.
Mean terminal half-life estimates ranged from 3.0 to 52.7 hours, and
mean, non-compartmentally derived, values
for total body clearance ranged from 11.6 to 24.0 l/hr/m
2
; total body clearance appeared to decrease with higher
plasma concentrations of paclitaxel. Mean steady-state volume of
distribution ranged from 198 to 688 l/m
2
,
indicating extensive extravascular distribution and/or tissue binding.
With the 3-hour infusion, increasing doses
result in non-linear pharmacokinetics. For the 30% increase in dose
from 135 mg/m
2
to 175 mg/m
2
, the Cmax and
AUC
→
∞
values increased 75% and 81%, respectively.
Intrapatient variability in systemic paclitaxel exposure was minimal.
There was no evid