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SPC, UK: Jevtana (2012)

Αναφορές

Βιβλιογραφική αναφορά

Στοιχεία εκδότη

Εκδότης :
SANOFI
Διεύθυνση :
1 Onslow Street, Guildford, Surrey, GU1 4YS, UK
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Δωρεάν εγγραφή

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 ...

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.

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 ...

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 ...

Contraindications

Hypersensitivity to cabazitaxel, to other taxanes, or to any excipients of the formulation including polysorbate 80. Neutrophil counts less than 1,500/mm³. Hepatic impairment (bilirubin ≥1 x ULN, or AST ...

Special warnings and precautions for use

Hypersensitivity reactions All patients should be pre-medicated prior to the initiation of the infusion of cabazitaxel (see section 4.2). Patients should be observed closely for hypersensitivity reactions ...

Shelf life

No interaction studies have been performed. In vitro studies have shown that cabazitaxel is mainly metabolised through CYP3A (80% to 90%) and inhibits CYP3A. CYP3A inhibitors Though no formal drug interaction ...

Fertility, pregnancy and lactation

Pregnancy There are no data from the use of cabazitaxel in pregnant women. Studies in animals have shown reproductive toxicity at maternotoxic doses (see section 5.3) and that cabazitaxel crosses the placenta ...

Effects on ability to drive and use machines

Based on the safety profile, cabazitaxel may have moderate influence on the ability to drive and use machines as it may cause fatigue and dizziness. Patients should be advised not to drive or use machines ...

Undesirable effects

Summary of safety profile The safety of JEVTANA in combination with prednisone or prednisolone was evaluated in 371 patients with hormone refractory metastatic prostate cancer who were treated with 25 ...

Overdose

There is no known antidote to JEVTANA. The anticipated complications of overdose would consist of exacerbation of adverse reactions as bone marrow suppression and gastrointestinal disorders. In case of ...

Pharmacodynamic properties

Pharmacotherapeutic group: Antineoplastic agents, Taxanes ATC code: not yet assigned Mechanism of action Cabazitaxel is an antineoplastic agent that acts by disrupting the microtubular network in cells. ...

Pharmacokinetic properties

A population pharmacokinetic analysis was carried out in 170 patients including patients with advanced solid tumours (n=69), metastatic breast cancer (n=34) and metastatic prostate cancer (n=67). These ...

Preclinical safety data

Adverse reactions not observed in clinical studies, but seen in dogs after single dose, 5-day and weekly administation at exposure levels lower than clinical exposure levels and with possible relevance ...

List of excipients

Concentrate Polysorbate 80 Citric acid Solvent Ethanol 96% Water for injections

Incompatibilities

This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6. PVC infusion containers or polyurethane infusion sets should not be used for the preparation ...

Shelf life

Unopened vials: 3 years After opening: The concentrate and solvent vials must be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user. After ...

Special precautions for storage

Do not store above 30°C. Do not refrigerate. For storage conditions after dilution of the medicinal product, see section 6.3.

Nature and contents of container

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 ...

Special precautions for disposal and other handling

JEVTANA should only be prepared and administered by personnel trained in handling cytotoxic agents. Pregnant staff should not handle the product. As for any other antineoplastic agent, caution should be ...

Marketing authorization holder

Sanofi-aventis groupe 54, rue La Boétie F 75008 Paris France

Marketing authorization holder

EU/1/11/676/001

Date of first authorization / renewal of the authorization

Date of first authorisation: 17 March 2011

Date of revision of the text

10 September 2012