JEVTANA 60mg CONCENTRATE AND SOLVENT FOR SOLUTION FOR INFUSION

Land: Malaysia

Sprache: Englisch

Quelle: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Wirkstoff:

CABAZITAXEL 60MG/1.5ML

Verfügbar ab:

SANOFI-AVENTIS (MALAYSIA) SDN. BHD.

INN (Internationale Bezeichnung):

CABAZITAXEL 60MG/1.5ML

Einheiten im Paket:

1Units Units; 1Units Units

Hergestellt von:

Sanofi-Aventis Deutschland GmbH

Fachinformation

NAME OF THE MEDICINAL PRODUCT
JEVTANA 60 mg concentrate and solvent for solution for infusion.
_ _
QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml of concentrate contains 40 mg cabazitaxel.
Each 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.
Excipients with known effect:
Each vial of solvent contains 573.3 mg of ethanol 96%.
For the full list of excipients, see section
_List of Excipients_
.
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.
CLINICAL PARTICULARS
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
_Pharmacodynamic Properties_
).
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
_Special Warnings and Precautions for Use_
).
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 sev