Cabazitaxel Fresenius Kabi 20 mg/ml concentrate for solution for infusion

Land: Irland

Sprog: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv bestanddel:

Cabazitaxel

Tilgængelig fra:

Fresenius Kabi Deutschland GmbH

ATC-kode:

L01CD04

INN (International Name):

Cabazitaxel

Lægemiddelform:

Concentrate for solution for infusion

Terapeutisk område:

cabazitaxel

Autorisation status:

Not marketed

Autorisation dato:

2023-01-06

Indlægsseddel

UK-IE PIL Carbazitaxel V001
1
PACKAGE LEAFLET: INFORMATION FOR THE
PATIENT
CABAZITAXEL FRESENIUS KABI 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 Fresenius Kabi is and what it is used for
2
What you need to know before you are given Cabazitaxel Fresenius Kabi
3
How to use Cabazitaxel Fresenius Kabi
4
Possible side effects
5
How to store Cabazitaxel Fresenius Kabi
6
Contents of the pack and other information
1.
WHAT CABAZITAXEL FRESENIUS KABI IS AND WHAT IT IS USED FOR
The name of your medicine is Cabazitaxel Fresenius Kabi. Its common
name is cabazitaxel. It
belongs to a group of medicines called “taxanes” used to treat
cancers.
Cabazitaxel Fresenius Kabi 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 FRESENIUS KABI
DO NOT USE CABAZITAXEL FRESENIUS KABI IF
•
you are allergic to cabazitaxel, to other taxanes, or polysorbate 80
or any of the other
ingredients 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 Fresenius Kabi if any of the above
apply t

Produktets egenskaber

Health Products Regulatory Authority
06 January 2023
CRN00C8K4
Page 1 of 18
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cabazitaxel Fresenius Kabi 20 mg/ml concentrate for solution for
infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of concentrate contains 20 mg cabazitaxel.
Each 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 1185,0 mg ethanol anhydrous.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Concentrate for solution for infusion.
The concentrate is a clear colorless to pale yellow solution
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Cabazitaxel Fresenius Kabi 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 Fresenius Kabi 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 o