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JEVTANA Concentrate and solvent for solution for infusion (2019)

Active ingredients: Cabazitaxel

Product Name and Form

JEVTANA 60 mg concentrate and solvent for solution for infusion.

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.

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.

Excipient with known effect: Each vial of solvent contains 573.3 mg of ethanol 96%.

For the full list of excipients, see section 6.1.

Chemical substance
Description
Cabazitaxel

Cabazitaxel is an antineoplastic agent that acts by disrupting the microtubular network in cells. Cabazitaxel binds to tubulin and promotes the assembly of tubulin into microtubules while simultaneously inhibiting their disassembly.

List of excipients

Concentrate:

Polysorbate 80
Citric acid

Solvent:

Ethanol 96%
Water for injections

Pack sizes and Marketing

One pack contains one vial of concentrate and one vial of solvent:

Concentrate: 1.5 ml of concentrate in a 15 ml clear glass vial (type I) closed with a grey chlorobutyl rubber closure sealed by an aluminium cap covered with a light green plastic flip-off cap. Each vial contains 60 mg cabazitaxel per 1.5 ml nominal volume (fill volume: 73.2 mg of cabazitaxel/1.83 ml). This fill volume has been established during the development of JEVTANA to compensate for liquid loss during preparation of the premix. This overfill ensures that after dilution with the entire content of the accompanying solvent for JEVTANA, there is a minimal extractable premix volume of 6 ml containing 10 mg/ml JEVTANA which corresponds to the labelled amount of 60 mg per vial.

Solvent: 4.5 ml of solvent in a 15 ml clear glass vial (type I) closed with a grey chlorobutyl rubber closure sealed by a gold colour aluminium cap covered with a colourless plastic flip-off cap. Each vial contains 4.5 ml nominal volume (fill volume: 5.67 ml). This fill volume has been established during the development and the overfill ensures, after the addition of the entire content of the solvent vial to the content of JEVTANA 60 mg concentrate vial, a concentration of the premix solution of 10 mg/ml JEVTANA.

Marketing authorization holder
Authorization dates

Sanofi-aventis groupe, 54, rue La Bo├ętie, F-75008 Paris, France

Date of first authorisation: 17 March 2011
Date of latest renewal: 19 November 2015

Marketing authorization number:

EU/1/11/676/001