JEVTANA Concentrate and solvent for solution for infusion (2019)
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Περιεχόμενα
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 adult patients with metastatic castration resistant prostate cancer previously treated with a docetaxel-containing ...
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 polysorbate 80 or any excipients listed in section 6.1. Neutrophil counts less than 1,500/mm³. Severe hepatic impairment (total bilirubin >3 x ULN). ...
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 ...
Interaction with other medicinal products and other forms of interaction
In vitro studies have shown that cabazitaxel is mainly metabolised through CYP3A (80% to 90%) (see section 5.2). CYP3A inhibitors Repeated administration of ketoconazole (400 mg once daily), a strong CYP3A ...
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
Cabazitaxel may influence the ability to drive and use machines as it may cause fatigue and dizziness. Patients should be advised not to drive or use machines if they experience these adverse reactions ...
Undesirable effects
Summary of safety profile The safety of JEVTANA in combination with prednisone or prednisolone was evaluated in 371 patients with metastatic castration resistant prostate cancer who were treated with 25 ...
Overdose
There is no known antidote to cabazitaxel. The anticipated complications of overdose would consist of exacerbation of adverse reactions as bone marrow suppression and gastrointestinal disorders. In case ...
Pharmacodynamic properties
Pharmacotherapeutic group: Antineoplastic agents, taxanes ATC code: L01CD04 Mechanism of action Cabazitaxel is an antineoplastic agent that acts by disrupting the microtubular network in cells. Cabazitaxel ...
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
<u>Unopened vials:</u> 3 years. <u>After opening:</u> The concentrate and solvent vials must be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of ...
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 number(s)
EU/1/11/676/001
Date of first authorization / renewal of the authorization
Date of first authorisation: 17 March 2011 Date of latest renewal: 19 November 2015
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