CABAZITAXEL SANOFI

দেশ: অস্ট্রেলিয়া

ভাষা: ইংরেজি

সূত্র: Department of Health (Therapeutic Goods Administration)

সক্রিয় উপাদান:

cabazitaxel acetone solvate

থেকে পাওয়া:

Sanofi-Aventis Australia Pty Ltd

INN (আন্তর্জাতিক নাম):

cabazitaxel acetone solvate

তথ্য লিফলেট

CABAZITAXEL SANOFI
®
_ _
_Cabazitaxel (ca-ba-zi-tax-el) _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Cabazitaxel Sanofi.
It does not contain all the available
information. It does not take the
place of talking to your doctor.
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.
Keep this leaflet in a safe place as
you may need to read it again.
WHAT CABAZITAXEL
SANOFI IS USED FOR
The name of your medicine is
Cabazitaxel Sanofi. It belongs to a
group of medicines called 'taxanes'
used to treat cancers. Cabazitaxel
Sanofi is used to treat prostate cancer
that has progressed after having had
other chemotherapy. It works by
stopping cells from growing and
multiplying.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY IT HAS BEEN
PRESCRIBED FOR YOU.
This medicine is only available with
a doctor's prescription.
There is no evidence that this
medicine is addictive.
BEFORE YOU ARE GIVEN
CABAZITAXEL SANOFI
DO NOT RECEIVE CABAZITAXEL SANOFI
IF:
•
the number of your white blood
cells is too low (neutrophil counts
of 1,500 per cubic millimetre, or
less - your doctor will advise you
on this),
•
you have a liver disease
•
you are pregnant or breast-
feeding
•
you have recently received or are
about to receive a vaccine against
yellow fever.
DO NOT RECEIVE CABAZITAXEL SANOFI
IF YOU ARE ALLERGIC TO IT OR ANY OF THE
INGREDIENTS LISTED AT THE END OF THIS
LEAFLET.
Some symptoms of an allergic
reaction include skin rash, itching,
shortness of breath or swelling of the
face, lips or tongue, which may cause
difficulty in swallowing or breathing.
DO NOT RECEIVE CABAZITAXEL SANOFI
IF YOU ARE PREGNANT OR INTEND TO
BECOME PREGNANT.
Cabazitaxel Sanofi may affect your
developing baby if you are given
Cabazitaxel Sanofi during pregnancy.
If your partner is pregnant or is
planning on bec

পণ্য বৈশিষ্ট্য

PRODUCT INFORMATION
CABAZITAXEL SANOFI
®
NAME OF THE MEDICINE
NON-PROPRIETARY NAME
Cabazitaxel
CHEMICAL STRUCTURE
The chemical structure of cabazitaxel is:
,
O
O
O
HO
O
O
O
O
O
H
O
OH
NH
O
O
O
O
DESCRIPTION
Cabazitaxel belongs to the taxanes class. It is prepared by semi
synthesis with a precursor
extracted from yew needles.
Chemical name of cabazitaxel is
(2α,5β,7β,10β,13α)-4-acetoxy-13-({(2R,3S)-3-
[(tertbutoxycarbonyl)
amino]-2-hydroxy-3-phenylpropanoyl}oxy)-1-hydroxy-7,10-dimethoxy-9-oxo-
5,20-epoxytax-11-en-2-yl benzoate - propan-2-one (1:1).
Cabazitaxel is a white to off-white powder with a molecular formula of
C
45
H
57
NO
14
,C
3
H
6
O and a
molecular weight of 894.01 (for the acetone solvate) / 835.93 (for the
solvent free). It is lipophilic,
practically insoluble in water and soluble in alcohol.
Cabazitaxel Sanofi (cabazitaxel) 60 mg/1.5 mL concentrate is a
sterile, non-pyrogenic, clear yellow
to brownish-yellow viscous solution and is available in single-use
vials containing 60 mg (1.5 mL)
cabazitaxel and 1.56 mg polysorbate 80.
Each mL of concentrate contains 40 mg cabazitaxel (anhydrous), 1.04 mg
polysorbate 80 and citric
acid.
Diluent for Cabazitaxel Sanofi is a clear, colourless, sterile, and
non-pyrogenic, solution containing
13% (w/w) ethanol in water for injection, 4.5 mL.
PHARMACOLOGY
CLASS
Antineoplastic agent
ATC code: L01CD04
SITE AND MODE OF ACTION
Cabazitaxel is an antineoplastic agent that acts by disrupting the
microtubular network in cells.
Cabazitaxel binds to tubulin and promotes the assembly of tubulin into
microtubules while
simultaneously inhibiting their disassembly. This leads to the
stabilisation of microtubules, which
results in the inhibition of mitotic and interphase cellular
functions.
cabazitaxel-sanofi-ccdsv10-piv7-
17mar17
_ _
_Page 1 _
PHARMACODYNAMICS
Cabazitaxel demonstrated a broad spectrum of antitumour activity
against advanced human
tumours xenografted in mice, including intracranial human
glioblastomas. Cabazitaxel is active in
docetaxel-sensitive tumours. I