TAXOTERE docetaxel 20mg/1mL injection vial

Nazione: Australia

Lingua: inglese

Fonte: Department of Health (Therapeutic Goods Administration)

Principio attivo:

Docetaxel

Commercializzato da:

Sanofi-Aventis Australia Pty Ltd

INN (Nome Internazionale):

Docetaxel

Foglio illustrativo

TAXOTERE
®
(TAX-O-TEAR)
_Docetaxel (dox-e-tax-elle)_
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Taxotere.
It does not contain all the available
information. It does not take the
place of talking to your doctor, nurse
or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you being given this
medicine against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN THIS MEDICINE, ASK YOUR
DOCTOR, NURSE OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT TAXOTERE IS USED
FOR
Taxotere is used to treat breast
cancer, ovarian cancer, some types of
lung cancer, head and neck cancer
and prostate cancer.
Taxotere works by stopping cells
from growing and multiplying.
Taxotere belongs to a group of
medicines called antineoplastic or
cytotoxic medicines. You may also
hear of these being called
chemotherapy medicines.
Your doctor, however, may prescribe
Taxotere for another purpose.
ASK YOUR DOCTOR, NURSE OR
PHARMACIST IF YOU HAVE ANY
QUESTIONS ABOUT WHY TAXOTERE HAS
BEEN PRESCRIBED FOR YOU.
You may have probably taken
another medicine to treat your breast,
ovarian, lung, head and neck or
prostate cancer. However, your
doctor has now decided to treat you
with Taxotere.
Taxotere may be used alone or in
combination with other medicines to
treat cancer.
This medicine is only available with
a doctor's prescription.
Taxotere is not addictive.
BEFORE YOU ARE GIVEN IT
_WHEN YOU MUST NOT BE GIVEN_
_IT_
Taxotere is not recommended for use
in children.
DO NOT RECEIVE TAXOTERE IF YOU HAVE
AN ALLERGY TO DOCETAXEL OR ANY OF
THE INGREDIENTS LISTED AT THE END OF
THIS LEAFLET.
Symptoms of an allergic reaction
include:
•
shortness of breath, wheezing,
difficulty breathing or a tight
feeling in your chest
•
swelling of the face, lips, tongue
or other parts of the body
•
rash, itching, hives or flushed, red
skin
•
dizziness or light-headedness
•
back pain
DO NOT RE

Scheda tecnica

PRODUCT INFORMATION
Taxotere (1-Vial) - docetaxel
taxotere-1-vial-ccdsv34-piv28-9nov17
Page 1
PRODUCT INFORMATION
TAXOTERE
®
NAME OF THE MEDICINE
AUSTRALIAN APPROVED NAME
Docetaxel
CHEMICAL STRUCTURE
Molecular Formula: C
43
H
53
NO
14
.3H2O
Molecular Weight: 861.9
Chemical Name: (2R,3S)-N-carboxy-3-phenylisoserine, N-tert-butyl
ester, 13-ester with 5β, 20
epoxy 1, 2α , 4, 7β, 10β, 13α -hexahydroxytax-11-en-9-one
4-acetate 2-
benzoate, trihydrate
CAS REGISTRY NUMBER
148408-66-6
PRODUCT INFORMATION
Taxotere (1-Vial) - docetaxel
taxotere-1-vial-ccdsv34-piv28-9nov17
Page 2
DESCRIPTION
DOCETAXEL
Docetaxel is a white to almost white powder. It is highly lipophilic
and practically insoluble in
water.
Single-dose vials of TAXOTERE concentrated injection containing 20 or
80 or 160mg of
docetaxel per 1.0 or 4.0 or 8.0mL, respectively, in 50/50 (v/v)
polysorbate 80/ absolute ethanol.
The sterile pyrogen-free viscous solution contains 20mg/mL docetaxel
(anhydrous).
In each TAXOTERE 20mg/1ml concentrate vial, the absolute ethanol
amount is 395 mg.
In each TAXOTERE 80mg/4ml concentrate vial, the absolute ethanol
amount is 1.58 g.
In each TAXOTERE 160mg/8ml concentrate vial, the absolute ethanol
amount is 3.16 g.
PHARMACOLOGY
CLASS
TAXOTERE is an antineoplastic agent which acts by promoting the
assembly of tubulin into
stable microtubules and inhibits their disassembly which leads to a
marked decrease of free
tubulin. The binding of docetaxel to microtubules does not alter the
number of protofilaments.
PHARMACODYNAMICS
MECHANISM OF ACTION
TAXOTERE has been shown in vitro to disrupt the microtubular network
in cells which is
essential for vital mitotic and interphase cellular functions.
_PRECLINICAL DATA _
TAXOTERE was found to be cytotoxic
_in vitro_
against various murine and human tumour cell
lines and against freshly excised human tumour cells in clonogenic
assays. Docetaxel achieves
high intracellular concentrations with a long cell residence time. In
addition, TAXOTERE was
found to be active on some, but not all, cel