Cabazitaxel Accord

Riik: Euroopa Liit

keel: inglise

Allikas: EMA (European Medicines Agency)

Toimeaine:

cabazitaxel

Saadav alates:

Accord Healthcare S.L.U.

ATC kood:

L01CD04

INN (Rahvusvaheline Nimetus):

cabazitaxel

Terapeutiline rühm:

Antineoplastic agents

Terapeutiline ala:

Prostatic Neoplasms, Castration-Resistant

Näidustused:

Treatment of patients with hormone refractory metastatic prostate cancer previously treated with a docetaxel-containing regimen.

Toote kokkuvõte:

Revision: 5

Volitamisolek:

Authorised

Loa andmise kuupäev:

2020-08-28

Infovoldik

31
B.
PACKAGE LEAFLET
32
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CABAZITAXEL ACCORD 20 MG/ML CONCENTRATE 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 Accord is and what it is used for
2
What you need to know before you are given Cabazitaxel Accord
3
How to use Cabazitaxel Accord
4
Possible side effects
5
How to store Cabazitaxel Accord
6
Contents of the pack and other information
1.
WHAT CABAZITAXEL ACCORD IS AND WHAT IT IS USED FOR
The name of your medicine is Cabazitaxel Accord. Its common name is
cabazitaxel. It belongs to a
group of medicines called “taxanes” used to treat cancers.
Cabazitaxel Accord is used to treat adults with 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 ACCORD
DO NOT USE CABAZITAXEL ACCORD 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 Accord if any of the above apply
to you. If you are not sure,
talk to your doctor before having Cab

Toote omadused

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Cabazitaxel Accord 20 mg/ml concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml of concentrate contains 20 mg cabazitaxel.
One vial of 3 ml of concentrate contains 60 mg cabazitaxel.
Excipient with known effect
The finished product contains 395 mg/ml of ethanol anhydrous, thus
each 3 ml vial contains 1,185 mg
ethanol anhydrous.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion (sterile concentrate).
The concentrate is a clear colourless to pale yellow or brownish
yellow solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Cabazitaxel Accord 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 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 least 30
minutes prior to each
administration of cabazitaxel with the following intravenous medicinal
products to mitigate the risk and
severity of hypersensitivity:
•
antihistamine (dexchlorpheniramine 5 mg or diphenhydramine 25 mg or
equivalent),
•
corticosteroid (dexamethasone 8 mg or equivalent), and
•
H2 antagonist (ranitidine or equivalent) (see section 4.4).
Antiemetic prophylaxis is recommended and can be given orally or
intravenously as needed.
Throughout the treatment, adequate hydration of the patient needs to
be ensured, in order to prevent
complications like renal failure.
P