DOCETAXEL DAKOTA docetaxel 160mg/8mL concentrated injection vial

Country: অস্ট্রেলিয়া

ভাষা: ইংরেজি

সূত্র: Department of Health (Therapeutic Goods Administration)

সক্রিয় উপাদান:

Docetaxel

থেকে পাওয়া:

Sanofi-Aventis Australia Pty Ltd

INN (International Name):

Docetaxel

তথ্য লিফলেট

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 DOCETAXEL DAKOTA
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

পণ্য বৈশিষ্ট্য

PRODUCT INFORMATION
Docetaxel Dakota - docetaxel
docetaxel-dakota-160mg-ccdsv34-piv28-9nov17
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
Docetaxel Dakota - docetaxel
docetaxel-dakota-160mg-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
DAKOTA
concentrated
injection
containing
160mg
of
docetaxel per 8.0mL in 50/50 (v/v) polysorbate 80/absolute ethanol.
The sterile pyrogen-free
viscous solution contains 20mg/mL docetaxel (anhydrous).
In each DOCETAXEL DAKOTA 160mg/8ml concentrate vial, the absolute
ethanol amount is
3.16 g.
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
addition,
DOCETAXEL DAKOTA was found to be active on some, but not all, cell
lines overexpressing
the p-glycoprotein which is encoded by the multidrug resistance gene.
In vivo, DOCETAXEL
DAKOTA is schedule independe