资料单张
TAXOL
®
_Paclitaxel_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Taxol. It does not
take the place of talking to your
doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Taxol against
the benefits that are expected. This
leaflet does not contain everything
about Taxol. Your doctor has been
provided with full information and
can answer any questions you may
have. Follow your doctor's advice
even if it differs from what is in this
leaflet.
Please read this leaflet carefully and
keep it in a safe place so you may
refer to it later.
WHAT TAXOL IS USED FOR
Taxol is used to treat cancer of the
ovary, the breast, and non small cell
cancer of the lung. Taxol may be
used alone or in combination with
other anticancer agents.
Taxol is not recommended for use in
children as its safety and
effectiveness in patients under 18
years of age has not been established.
Ask your doctor if you have any
questions about why Taxol was
prescribed for you.
_HOW TAXOL WORKS_
Taxol belongs to a class of anticancer
agents known as taxanes. These
agents prevent the division of cells,
particularly cancer cells.
The use of Taxol to treat your cancer
can lead to side-effects, which are
discussed below.
_HOW TAXOL IS USED_
Taxol will be administered as an
infusion in a hospital clinic. Taxol
may be used alone or with other
anticancer medicines.
The dose is worked out based on
your body weight and height, and so
may be different from the dose
chosen for other people. Taxol is
administered as an intravenous
infusion over a 3 hour period.
Administration will occur at 3 week
intervals. The administration of
Taxol requires all patients to be given
premedication prior to Taxol.
The premedication consists of three
other drugs which work by reducing
the likelihood of an allergic reaction
occurring when you receive your
Taxol. They are given as tablets 12
and 6 hours before the Taxol is given
and two injections into the vein
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产品特点
Taxol V5 26 August 2013
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PRODUCT INFORMATION
TAXOL
NAME OF THE MEDICINE
TAXOL contains paclitaxel, a natural product with antitumour activity. TAXOL is the first of a new
class of anticancer agents known as taxanes.
The CAS number for paclitaxel is 33069-62-4 (USAN).
Paclitaxel has the following structural formula:
Molecular Formula: C
47
H
51
NO
14
Molecular Weight: 853.929
DESCRIPTION
Paclitaxel is a white to off-white crystalline powder that is highly lipophilic and insoluble in water.
PHARMACOLOGY
PHARMACOKINETICS
The pharmacokinetics of paclitaxel have been evaluated over a wide range of doses, up to 300
mg/m
2
, and infusion schedules, ranging from 3 to 24 hours.
Following intravenous administration, paclitaxel exhibits a biphasic decline in plasma
concentrations. The initial rapid decline represents distribution to the peripheral compartment and
elimination; the later phase is due, in part, to a relatively slow efflux of paclitaxel from the
peripheral compartment. Maximum plasma concentrations are related to dose. In patients treated
with doses of 135 and 175 mg/m
2
given as 3 and 24 hour infusions, mean terminal half-life has
ranged from 3.0 to 52.7 hours, and total body clearance has ranged
from 11.6 to 24.0 L/h/m
2
.
Taxol V5 26 August 2013
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Mean steady state volume of distribution following single dose infusion of 135 and 175 mg/m
2
has
ranged from 198 to 688 L/m
2
, indicating extensive extravascular distribution and/or tissue binding.
The volume of distribution is reduced in female subjects. Following 3 hour infusions of 175 mg/m
2
,
mean terminal half-life was estimated to be 9.9 hours; mean total body cle
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