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Φάρμακα Δραστικές ουσίες Συμπληρώματα διατροφής Έλεγχος συγχορήγησης Νόσοι ICD-10
Κλαύδιος Γαληνός
Είσοδος χρηστών
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Βιβλιογραφική αναφορά

Προτάσεις

SPC, UK: Jevtana (2012)

Εκδότης

Εκδότης SANOFI
Διεύθυνση 1 Onslow Street, Guildford, Surrey, GU1 4YS, UK
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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 ...

Pharmaceutical form

Concentrate and solvent for solution for infusion (sterile concentrate). The concentrate is a clear yellow ...

Therapeutic indications

JEVTANA in combination with prednisone or prednisolone is indicated for the treatment of patients with ...

Posology and method of administration

The use of JEVTANA should be confined to units specialised in the administration of cytotoxics and it ...

Contraindications

Hypersensitivity to cabazitaxel, to other taxanes, or to any excipients of the formulation including ...

Special warnings and precautions for use

Hypersensitivity reactions All patients should be pre-medicated prior to the initiation of the infusion ...

Shelf life

No interaction studies have been performed. In vitro studies have shown that cabazitaxel is mainly metabolised ...

Fertility, pregnancy and lactation

Pregnancy There are no data from the use of cabazitaxel in pregnant women. Studies in animals have shown ...

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 ...

Undesirable effects

Summary of safety profile The safety of JEVTANA in combination with prednisone or prednisolone was evaluated ...

Overdose

There is no known antidote to JEVTANA. The anticipated complications of overdose would consist of exacerbation ...

Pharmacodynamic properties

Pharmacotherapeutic group: Antineoplastic agents, Taxanes ATC code: not yet assigned Mechanism of action ...

Pharmacokinetic properties

A population pharmacokinetic analysis was carried out in 170 patients including patients with advanced ...

Preclinical safety data

Adverse reactions not observed in clinical studies, but seen in dogs after single dose, 5-day and weekly ...

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 ...

Shelf life

Unopened vials: 3 years After opening: The concentrate and solvent vials must be used immediately. If ...

Special precautions for storage

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

Nature and contents of container

One pack contains one vial of concentrate and one vial of solvent: Concentrate: 1.5 ml of concentrate ...

Special precautions for disposal and other handling

JEVTANA should only be prepared and administered by personnel trained in handling cytotoxic agents. Pregnant ...

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
Απαγορεύεται η αναπαραγωγή και αναδιανομή. Το έργο επεξεργασίας των παραπάνω πληροφοριών αποτελεί πνευματική ιδιοκτησία της Ergobyte Πληροφορική Α.Ε. και προστατεύεται από τη νομοθεσία περί πνευματικών δικαιωμάτων.