DOCETAXEL TEVA Concentrate and solvent for solution (2019)
Βιβλιογραφική αναφορά
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Περιεχόμενα
Name of the medicinal product
Docetaxel Teva 20 mg/0.72 ml concentrate and solvent for solution for infusion.
Qualitative and quantitative composition
Each vial of Docetaxel Teva 20 mg/0.72 ml concentrate contains 20 mg docetaxel. Each ml of concentrate contains 27.73 mg docetaxel. Excipients with known effect: Each vial of concentrate contains 25.1% ...
Pharmaceutical form
Concentrate and solvent for solution for infusion. The concentrate is a clear viscous, yellow to brown-yellow solution. The solvent is a colourless solution.
Therapeutic indications
Breast cancer Docetaxel Teva 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. Docetaxel must not be used in patients with baseline neutrophil count of <1,500 cells/mm³. Docetaxel must not ...
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
The amount of alcohol in this medicinal product may alter the effects of other medicinal products. 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 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. The amount of alcohol in this medicinal product and the side effects of the product may impair the ability to drive ...
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: 1,312 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
<u>Concentrate vial:</u> Polysorbate 80 Ethanol, anhydrous <u>Solvent vial:</u> Water for injections
Incompatibilities
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Shelf life
Shelf life: 18 months. Premix solution: Chemical and physical in-use stability has been demonstrated for 8 hours when stored either between 2°C and 8°C or at room temperature (below 25°C). From a microbiological ...
Special precautions for storage
Do not store above 25°C. Do not freeze. 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
Each carton contains: One vial of concentrate and, One vial of solventDocetaxel Teva 20 mg/0.72 ml concentrate for solution for infusion vial 6 ml clear glass Type I vial with a bromobutyl rubber stopper ...
Special precautions for disposal and other handling
Docetaxel Teva is an antineoplastic agent and, as with other potentially toxic compounds, caution should be exercised when handling it and preparing Docetaxel solutions. The use of gloves is recommended. ...
Marketing authorization holder
Teva B.V., Swensweg 5, 2031 GA, Haarlem, The Netherlands
Marketing authorization number(s)
EU/1/09/611/001
Date of first authorization / renewal of the authorization
Date of first authorisation: 26 January 2010 Date of latest renewal: 22 May 2014
Πηγαίο έγγραφο
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:
