DOCETAXEL DAKOTA
Country: Аустралија
Језик: Енглески
Извор: Department of Health (Therapeutic Goods Administration)
Информативни летак
(PIL)
20-05-2024
Карактеристике производа
(SPC)
20-05-2024
Активни састојак:
Docetaxel
Доступно од:
Sanofi-Aventis Australia Pty Ltd
Класа:
Medicine Registered
Информативни летак
docetaxel-dakota-ccdsv25-27-cmiv2-23oct12
1
_ _
DOCETAXEL DAKOTA
_DOCETAXEL _
_(DOX-E-TAX-ELLE)_
_ _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Docetaxel Dakota.
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
DAKOTA IS USED FOR
Docetaxel Dakota is used to treat
breast cancer, ovarian cancer, some
types of lung cancer, head and neck
cancer and prostate cancer.
Docetaxel Dakota works by
stopping cells from growing and
multiplying.
Docetaxel Dakota 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 Dakota for
another purpose.
ASK YOUR DOCTOR, NURSE OR
PHARMACIST IF YOU HAVE ANY
QUESTIONS ABOUT WHY DOCETAXEL
DAKOTA 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 Dakota.
Docetaxel Dakota may be used
alone or in combination with other
medicines to treat cancer.
This medicine is only available with
a doctor’s prescription.
Docetaxel Dakota is not addictive.
BEFORE YOU ARE GIVEN
IT
_WHEN YOU MUST NOT BE _
_GIVEN IT _
Docetaxel Dakota is not
recommended for use in children.
DO NOT RECEIVE DOCETA
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Карактеристике производа
PRODUCT INFORMATION
July 2013
Docetaxel Dakota - docetaxel
docetaxel-dakota-160mg-ccdsv28-piv23-12jul13
Page 1
PRODUCT INFORMATION
DOCETAXEL DAKOTA
®
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
July 2013
Docetaxel Dakota - docetaxel
docetaxel-dakota-160mg-ccdsv28-piv23-12jul13
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 DAKOTA concentrated injection containing 160mg of
docetaxel per 8.0mL in 50/50
(v/v) polysorbate 80/ethanol (anhydrous). The sterile pyrogen-free
viscous solution contains 20mg/mL docetaxel (anhydrous).
PHARMACOLOGY
CLASS
DOCETAXEL DAKOTA 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 DAKOTA 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 DAKOTA 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 add
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