MSN CABAZITAXEL cabazitaxel 60 mg/1.5 mL concentrated injection vial and diluent vial

Țară: Australia

Limbă: engleză

Sursă: Department of Health (Therapeutic Goods Administration)

Ingredient activ:

cabazitaxel, Quantity: 60 mg

Disponibil de la:

Reach Pharmaceuticals Pty Ltd

Forma farmaceutică:

Injection, diluent for

Compoziție:

Excipient Ingredients: ethanol; water for injections

Calea de administrare:

Intravenous Infusion

Unități în pachet:

1 vial of cabazitaxel concentrated injection and 1 vial of Diluent

Tip de prescriptie medicala:

(S4) Prescription Only Medicine

Indicații terapeutice:

MSN Cabazitaxel in combination with prednisone or prednisolone is indicated for the treatment of patients with metastatic castration resistant prostate cancer previously treated with a docetaxel containing regimen.

Rezumat produs:

Visual Identification: Clear colourless solution; Container Type: Multiple containers; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Statutul autorizaţiei:

Registered

Data de autorizare:

2020-08-26

Prospect

MSN Cabazitaxel CMI Ver 0.4
1
MSN CABAZITAXEL
_Cabazitaxel (ca-ba-zi-tax-el) _
_ _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about MSN
Cabazitaxel.
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 MSN CABAZITAXEL IS
USED FOR
The name of your medicine is
MSN Cabazitaxel. It belongs to a
group of medicines called
'taxanes' used to treat cancers.
MSN Cabazitaxel 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 MSN
CABAZITAXEL
DO NOT RECEIVE MSN
CABAZITAXEL 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
breastfeeding
•
you have recently received or
are about to receive a
vaccine against yellow fever.
DO NOT RECEIVE MSN
CABAZITAXEL 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 MSN
CABAZITAXEL IF YOU ARE PREGNANT
OR INTEND TO BECOME PREGNANT.
MSN Cabazitaxel may affect your
developing baby if you are given
MSN Cabazitaxel during
pregnancy. If your partner is
pregnant or is planning on
becoming pre

Caracteristicilor produsului

Cabazitaxel PI Ver 0.8
1
AUSTRALIAN PRODUCT INFORMATION – MSN CABAZITAXEL (CABAZITAXEL)
1.
NAME OF THE MEDICINE
Cabazitaxel
2.
QUALITIATIVE AND QUANTITATIVE COMPOSITION
Cabazitaxel is a white to off-white powder with a molecular formula of
C
45
H
57
NO
14
and a
molecular weight of 835.93 . It is lipophilic, practically insoluble
in water,freely soluble in
acetone and soluble in dichloromethane.
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.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3.
PHARMACEUTICAL FORM
MSN Cabazitaxel 60 mg/1.5 mL concentrate is a sterile, colourless to
pale yellow viscous
solution and is available in single-use vials containing 60 mg (1.5
mL) cabazitaxel and 1.56 g
polysorbate 80.
Each mL of concentrate contains 40 mg cabazitaxel (anhydrous) and 1.04
g polysorbate 80 .
Diluent for MSN Cabazitaxel is a clear, colourless, sterile, and
non-pyrogenic, solution
containing 13% (w/w) ethanol in water for injection, 4.5 mL.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
MSN Cabazitaxel in combination with prednisone or prednisolone is
indicated for the
treatment of patients with metastatic castration resistant prostate
cancer previously treated
with a docetaxel containing regimen.
4.2 DOSE AND METHOD OF ADMINISTRATION
The use of MSN Cabazitaxel should be confined to units specialised in
the administration of
cytotoxics and it should only be administered under the supervision of
a physician experienced
in the use of anticancer chemotherapy.
Do not use PVC infusion containers (bags or bottles) for the
preparation of the infusion
solution.
Do not use polyurethane infusion sets (tubing, filter, pumps) for the
administration of the
infusion solution.
PREMEDICATION
Premedicate at least 30 minute