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Βιβλιογραφική αναφορά

Προτάσεις

SPC, UK: Taxotere 20mg/1ml concentrate for solution for infusion (2012)

Εκδότης

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

Name of the medicinal product

TAXOTERE 20 mg/1 ml concentrate for solution for infusion.

Qualitative and quantitative composition

Each ml of concentrate contains 20 mg docetaxel (as trihydrate). One vial of 1 ml of concentrate contains ...

Pharmaceutical form

Concentrate for solution for infusion (sterile concentrate). The concentrate is a pale yellow to brownish-yellow ...

Therapeutic indications

Breast cancer TAXOTERE in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant ...

Posology and method of administration

The use of docetaxel should be confined to units specialised in the administration of cytotoxic chemotherapy ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Patients ...

Special warnings and precautions for use

For breast and non-small cell lung cancers, premedication consisting of an oral corticosteroid, such ...

Interaction with other medicinal products and other forms of interaction

In vitro studies have shown that the metabolism of docetaxel may be modified by the concomitant administration ...

Fertility, pregnancy and lactation

Pregnancy There is no information on the use of docetaxel in pregnant women. Docetaxel has been shown ...

Effects on ability to drive and use machines

No studies on the effects on the ability to drive and use machines have been performed.

Undesirable effects

Summary of the safety profile for all indications The adverse reactions considered to be possibly or ...

Overdose

There were a few reports of overdose. There is no known antidote for docetaxel overdose. In case of overdose, ...

Pharmacodynamic properties

Pharmacotherapeutic group: Taxanes ATC Code: L01CD02 Mechanism of action Docetaxel is an antineoplastic ...

Pharmacokinetic properties

Absorption The pharmacokinetics of docetaxel have been evaluated in cancer patients after administration ...

Preclinical safety data

The carcinogenic potential of docetaxel has not been studied. Docetaxel has been shown to be mutagenic ...

List of excipients

Polysorbate 80 Ethanol anhydrous Citric acid

Incompatibilities

This medicinal product must not be mixed with other medicinal products except those mentioned in section ...

Shelf life

Unopened vial: 2 years After opening of the vial Each vial is for single use and should be used immediately ...

Special precautions for storage

Do not store above 25°C. Store in the original package in order to protect from light. For storage conditions ...

Nature and contents of container

7 ml clear glass (type I) vial with a green aluminium seal and a green plastic flip-off cap containing ...

Special precautions for disposal and other handling

TAXOTERE is an antineoplastic agent and, as with other potentially toxic compounds, caution should be ...

Marketing authorization holder

Aventis Pharma S.A. 20 avenue Raymond Aron 92165 Antony Cedex France

Marketing authorization number(s)

EU/1/95/002/003

Date of first authorization / renewal of the authorization

Date of first authorisation: 27 November 1995 Date of latest renewal: 27 November 2005

Date of revision of the text

6 February 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.