Taxotere 20mg/1ml concentrate for solution for infusion (2012)
Βιβλιογραφική αναφορά
Στοιχεία εκδότη
| Εκδότης | SANOFI |
|---|---|
| Διεύθυνση | 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 20 mg of docetaxel. Excipient with known effect: Each vial of concentrate contains 0.5 ml of ethanol ...
Pharmaceutical form
Concentrate for solution for infusion (sterile concentrate). The concentrate is a pale yellow to brownish-yellow solution.
Therapeutic indications
Breast cancer TAXOTERE in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with: operable node-positive breast cancer. operable node-negative breast ...
Posology and method of administration
The use of docetaxel should be confined to units specialised in the administration of cytotoxic chemotherapy and it should only be administered under the supervision of a physician qualified in the use ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Patients with baseline neutrophil count of < 1,500 cells/mm<sup>3</sup>. Patients with severe liver impairment ...
Special warnings and precautions for use
For breast and non-small cell lung cancers, premedication consisting of an oral corticosteroid, such as dexamethasone 16 mg per day (e.g. 8 mg BID) for 3 days starting 1 day prior to docetaxel administration, ...
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 of compounds which induce, inhibit or are metabolised by (and thus may inhibit the enzyme ...
Fertility, pregnancy and lactation
Pregnancy There is no information on the use of docetaxel in pregnant women. Docetaxel has been shown to be both embryotoxic and foetotoxic in rabbits and rats, and to reduce fertility in rats. As with ...
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 probably related to the administration of docetaxel have been obtained in: 1312 and 121 patients who ...
Overdose
There were a few reports of overdose. There is no known antidote for docetaxel overdose. In case of overdose, the patient should be kept in a specialised unit and vital functions closely monitored. In ...
Pharmacodynamic properties
Pharmacotherapeutic group: Taxanes ATC Code: L01CD02 Mechanism of action Docetaxel is an antineoplastic agent which acts by promoting the assembly of tubulin into stable microtubules and inhibits their ...
Pharmacokinetic properties
Absorption The pharmacokinetics of docetaxel have been evaluated in cancer patients after administration of 20-115 mg/m² in phase I studies. The kinetic profile of docetaxel is dose independent and consistent ...
Preclinical safety data
The carcinogenic potential of docetaxel has not been studied. Docetaxel has been shown to be mutagenic in the in vitro micronucleus and chromosome aberration test in CHO-K1 cells and in the in vivo micronucleus ...
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 6.6.
Shelf life
Unopened vial: 2 years After opening of the vial Each vial is for single use and should be used immediately after opening. If not used immediately, in-use storage times and conditions are the responsibility ...
Special precautions for storage
Do not store above 25°C. Store in the original package in order to protect from light. For storage conditions of the diluted medicinal product, see section 6.3.
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 1 ml of concentrate. Each box contains one vial. Not all pack sizes may be marketed.
Special precautions for disposal and other handling
TAXOTERE is an antineoplastic agent and, as with other potentially toxic compounds, caution should be exercised when handling it and preparing TAXOTERE solutions. The use of gloves is recommended. If ...
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