SPC, UK: Taxotere 20mg/1ml concentrate for solution for infusion
||1 Onslow Street, Guildford, Surrey, GU1 4YS, UK
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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 ...
Concentrate for solution for infusion (sterile concentrate). The concentrate is a pale yellow to brownish-yellow ...
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 ...
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.
Summary of the safety profile for all indications The adverse reactions considered to be possibly or ...
There were a few reports of overdose. There is no known antidote for docetaxel overdose. In case of overdose, ...
Pharmacotherapeutic group: Taxanes ATC Code: L01CD02 Mechanism of action Docetaxel is an antineoplastic ...
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
This medicinal product must not be mixed with other medicinal products except those mentioned in section ...
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)
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.