Jevtana
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
06-07-2023
Charakterystyka produktu
(SPC)
06-07-2023
Sprawozdanie z oceny publicznego
(PAR)
05-05-2017
Składnik aktywny:
cabazitaxel
Dostępny od:
Sanofi Winthrop Industrie
Kod ATC:
L01CD
INN (International Nazwa):
cabazitaxel
Grupa terapeutyczna:
Antineoplastic agents
Dziedzina terapeutyczna:
Prostatic Neoplasms
Wskazania:
Jevtana in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone-refractory metastatic prostate cancer previously treated with a docetaxel-containing regimen.
Podsumowanie produktu:
Revision: 23
Status autoryzacji:
Authorised
Data autoryzacji:
2011-03-17
Ulotka dla pacjenta
33
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
VIAL LABEL FOR SOLVENT
1.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION
SOLVENT for JEVTANA
2.
METHOD OF ADMINISTRATION
USE THE ENTIRE CONTENT FOR DILUTION
(see package leaflet)
.
3.
EXPIRY DATE
EXP
4.
BATCH NUMBER
Lot
5.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
4.5 ml
(
ethanol 96% and water for injections
)
.
6.
OTHER
This vial contains an overfill.
34
B. PACKAGE LEAFLET
35
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
JEVTANA 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 JEVTANA is and what it is used for
2.
What you need to know before you are given JEVTANA
3.
How to use JEVTANA
4.
Possible side effects
5.
How to store JEVTANA
6.
Contents of the pack and other information
1.
WHAT JEVTANA IS AND WHAT IT IS USED FOR
The name of your medicine is JEVTANA. Its common name is cabazitaxel.
It belongs to a group of
medicines called “taxanes” used to treat cancers.
JEVTANA 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 JEVTANA
DO NOT USE JEVTANA 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
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Charakterystyka produktu
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
JEVTANA 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 JEVTANA 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
One 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 yellow to brownish-yellow oily solution.
The solvent is a clear and colourless solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
JEVTANA 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 JEVTANA 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 JEVTANA with the following intravenous medicinal
products to mitigate the risk
and severity of hypersensi
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