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

Summary of Product characteristics

PRODUCT INFORMATION
Docetaxel winthrop (1-vial)- docetaxel
docetaxel-winthrop-1vial-ccdsv34-piv28-9nov17
Page 1
PRODUCT INFORMATION
DOCETAXEL WINTHROP
®
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 winthrop (1-vial)- docetaxel
docetaxel-winthrop-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 WINTHROP 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 WINTHROP 20mg/1ml concentrate vial, the absolute
ethanol amount is
395 mg.
In each DOCETAXEL WINTHROP 80mg/4ml concentrate vial, the absolute
ethanol amount is
1.58 g.
In each DOCETAXEL WINTHROP 160mg/8ml concentrate vial, the absolute
ethanol amount is
3.16 g.
PHARMACOLOGY
CLASS
DOCETAXEL WINTHROP 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 WINTHROP 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 WINTHROP 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
co