Cabazitaxel MSN 60 mg concentrate and solvent for solution for infusion

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

Cabazitaxel

Tilgjengelig fra:

MSN Labs Europe Limited

ATC-kode:

L01CD04

INN (International Name):

Cabazitaxel

Legemiddelform:

Concentrate and solvent for solution for infusion

Terapeutisk område:

cabazitaxel

Autorisasjon dato:

2022-01-28

Informasjon til brukeren

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CABAZITAXEL MSN 60 MG CONCENTRATE AND SOLVENT FOR SOLUTION FOR
INFUSION
cabazitaxel
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor, pharmacist or
nurse.
•
If you get any side effects talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Cabazitaxel MSN is and what it is used for
2.
What you need to know before you are given Cabazitaxel MSN
3.
How to use Cabazitaxel MSN
4.
Possible side effects
5.
How to store Cabazitaxel MSN
6.
Contents of the pack and other information
1.
WHAT CABAZITAXEL MSN IS AND WHAT IT IS USED FOR
The name of your medicine is Cabazitaxel MSN. Its common name is
cabazitaxel. It belongs to a
group of medicines called “taxanes” used to treat cancers.
Cabazitaxel MSN is used to treat prostate cancer that has progressed
after having had other
chemotherapy. It works by stopping cells from growing and multiplying.
As part of your treatment, you will also take a corticosteroid
medicine (prednisone or prednisolone)
by mouth every day. Ask your doctor to give you information about this
other medicine.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN CABAZITAXEL MSN
DO NOT USE CABAZITAXEL MSN IF:
•
you are allergic (hypersensitive) to cabazitaxel, to other taxanes, or
polysorbate 80 or any of the
other excipients of this medicine (listed in section 6),
•
the number of your white blood cells is too low (neutrophil counts
less than or equal to 1,500
/mm
3
),
•
you have severe abnormal liver function,
•
you have recently received or are about to receive a vaccine against
yellow fever.
You should not be given Cabazitaxel MSN if any of the above apply to
you. If you are not sure, talk to
your doctor before having Cabazitaxel MSN.
WARNINGS AND PRECAUTIONS
Before each tr

Preparatomtale

Health Products Regulatory Authority
06 October 2023
CRN00DQTN
Page 1 of 21
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cabazitaxel MSN 60 mg concentrate and solvent for solution for
infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml of concentrate contains 40 mg cabazitaxel.
One vial of 1.5 ml (nominal volume) of concentrate contains 60 mg
cabazitaxel.
After initial dilution with the entire solvent, each ml of solution
contains 10 mg cabazitaxel.
Note: Both the Cabazitaxel MSN 60 mg/1.5 ml concentrate vial (fill
volume: 73.2 mg of cabazitaxel/1.83 ml) and the solvent vial
(fill volume: 5.67 ml) contain an overfill to compensate for liquid
loss during preparation. This overfill ensures that after dilution
with the ENTIRE contents of the accompanying solvent, there is
solution containing 10 mg/ml cabazitaxel.
Excipient with known effect
Each vial of solvent contains 573.3 mg of ethanol 96%.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Concentrate and solvent for solution for infusion (sterile
concentrate).
The concentrate is a clear colorless to pale yellow viscous solution
practically free from particles.
The solvent is a clear and colourless solution practically free from
particles.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Cabazitaxel MSN in combination with prednisone or prednisolone is
indicated for the treatment of adult patients with
metastatic castration resistant prostate cancer previously treated
with a docetaxel-containing regimen (see section 5.1).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The use of Cabazitaxel MSN 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. Facilities and equipment
for the treatment of serious hypersensitivity reactions like
hypotension and bronchospasm must be available (see section 4.4).
Premedication
The recommended premedication regimen should be performed at le