DOCETAXEL SANOFI docetaxel 20mg/1mL injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Docetaxel

Available from:

Sanofi-Aventis Australia Pty Ltd

INN (International Name):

Docetaxel

Patient Information leaflet

docetaxel-sanofi-ccdsv25-27-cmiv3-23oct12
1
_ _
DOCETAXEL SANOFI

_DOCETAXEL _
_(DOX-E-TAX-ELLE)_
_ _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Docetaxel Sanofi.
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 DOCETAXEL
SANOFI IS USED FOR
Docetaxel Sanofi is used to treat
breast cancer, ovarian cancer, some
types of lung cancer, head and neck
cancer and prostate cancer.
Docetaxel Sanofi works by
stopping cells from growing and
multiplying.
Docetaxel Sanofi 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 Docetaxel Sanofi for
another purpose.
ASK YOUR DOCTOR, NURSE OR
PHARMACIST IF YOU HAVE ANY
QUESTIONS ABOUT WHY DOCETAXEL
SANOFI 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 Docetaxel Sanofi.
Docetaxel Sanofi may be used
alone or in combination with other
medicines to treat cancer.
This medicine is only available with
a doctor’s prescription.
Docetaxel Sanofi is not addictive.
BEFORE YOU ARE GIVEN
IT
_WHEN YOU MUST NOT BE _
_GIVEN IT _
Docetaxel Sanofi is not
recommended for use in children.
DO NOT RECEIVE DOCETAXEL SANOFI 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 th

Summary of Product characteristics

PRODUCT INFORMATION
Docetaxel-sanofi-1vial - docetaxel
docetaxel-sanofi-1vial-ccdsv34-piv28-9nov17
Page 1
PRODUCT INFORMATION
DOCETAXEL SANOFI
®
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
Docetaxel-sanofi-1vial - docetaxel
docetaxel-sanofi-1vial-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 DOCETAXEL SANOFI 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 DOCETAXEL SANOFI 20mg/1ml concentrate vial, the absolute
ethanol amount is 395
mg.
In each DOCETAXEL SANOFI 80mg/4ml concentrate vial, the absolute
ethanol amount is 1.58
g.
In each DOCETAXEL SANOFI 160mg/8ml concentrate vial, the absolute
ethanol amount is 3.16
g.
PHARMACOLOGY
CLASS
DOCETAXEL SANOFI 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
DOCETAXEL SANOFI has been shown in vitro to disrupt the microtubular
network in cells
which is essential for vital mitotic and interphase cellular
functions.
_PRECLINICAL DATA _
DOCETAXEL SANOFI 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
cel