Jevtana® Concentrate and Solvent for Solution for Infusion 60mg1.5ml

国: シンガポール

言語: 英語

ソース: HSA (Health Sciences Authority)

有効成分:

Cabazitaxel

から入手可能:

SANOFI-AVENTIS SINGAPORE PTE. LTD.

ATCコード:

L01CD04

投薬量:

60mg/1.5ml

医薬品形態:

INFUSION, SOLUTION CONCENTRATE

構図:

Cabazitaxel 60mg/1.5ml

投与経路:

INTRAVENOUS

処方タイプ:

Prescription Only

製:

Sanofi-Aventis Deutschland GmbH (Drug Product & Solvent)

認証ステータス:

ACTIVE

承認日:

2011-11-02

情報リーフレット

1 

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. 

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 patients  with hormone refractory metastatic 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 

2 

The recommended premedication regimen should be performed at
least 30 minutes prior 
to each administration of JEVTANA with
the following intravenous medicinal product to 
mitigate the risk and severity of hypersensitivity: 

•  antihistamine (dexchlorpheniramine 5
mg or dip

製品の特徴

1
SG/JEV/0623/CCDSV11-12
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.
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.
Excipients with known effect:
One 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.
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 severity of hypersensitivity
2
SG/