TEPADINA Powder for concentrate for solution for infusion (2020)
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Περιεχόμενα
Name of the medicinal product
TEPADINA 15 mg powder for concentrate for solution for infusion.
Qualitative and quantitative composition
One vial of powder contains 15 mg thiotepa. After reconstitution with 1.5 ml of water for injections, each ml of solution contains 10 mg thiotepa (10 mg/ml). For the full list of excipients, see section ...
Pharmaceutical form
Powder for concentrate for solution for infusion. White crystalline powder.
Therapeutic indications
TEPADINA is indicated, in combination with other chemotherapy medicinal products: with or without total body irradiation (TBI), as conditioning treatment prior to allogeneic or autologous haematopoietic ...
Posology and method of administration
TEPADINA administration must be supervised by a physician experienced in conditioning treatment prior to haematopoietic progenitor cell transplantation. Posology TEPADINA is administered at different doses, ...
Contraindications
Hypersensitivity to the active substance. Pregnancy and lactation (see section 4.6). Concomitant use with yellow fever vaccine and with live virus and bacterial vaccines (see section 4.5).
Special warnings and precautions for use
The consequence of treatment with thiotepa at the recommended dose and schedule is profound myelosuppression, occurring in all patients. Severe granulocytopenia, thrombocytopenia, anaemia or any combination ...
Interaction with other medicinal products and other forms of interaction
Specific interactions with thiotepa Live virus and bacterial vaccines must not be administered to a patient receiving an immunosuppressive chemotherapeutic agent and at least three months must elapse between ...
Fertility, pregnancy and lactation
Women of childbearing potential Women of childbearing potential have to use effective contraception during treatment and a pregnancy test should be performed before treatment is started. Pregnancy There ...
Effects on ability to drive and use machines
TEPADINA may have major influence on the ability to drive and use machines. It is likely that certain adverse reactions of thiotepa like dizziness, headache and blurred vision could affect these functions. ...
Undesirable effects
Summary of the safety profile The safety of thiotepa has been examined through a review of adverse events reported in published data from clinical trials. In these studies, a total of 6,588 adult patients ...
Overdose
There is no experience with overdoses of thiotepa. The most important adverse reactions expected in case of overdose is myeloablation and pancytopenia. There is no known antidote for thiotepa. The haematological ...
Pharmacodynamic properties
Pharmacotherapeutic group: Antineoplastic agents, Alkylating Agents ATC code: L01AC01 Mechanism of action Thiotepa is a polyfunctional cytotoxic agent related chemically and pharmacologically to the nitrogen ...
Pharmacokinetic properties
Absorption Thiotepa is unreliably absorbed from the gastrointestinal tract: acid instability prevents thiotepa from being administered orally. Distribution Thiotepa is a highly lipophilic compound. After ...
Preclinical safety data
No conventional acute and repeat dose toxicity studies were performed. Thiotepa was shown to be genotoxic in vitro and in vivo, and carcinogenic in mice and rats. Thiotepa was shown to impair fertility ...
List of excipients
None.
Incompatibilities
TEPADINA is unstable in acid medium. This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Shelf life
Shelf life Unopened vial: 18 months. After reconstitution: Chemical and physical in-use stability after reconstitution has been demonstrated for 8 hours when stored at 2°C-8°C. After dilution: Chemical ...
Special precautions for storage
Unopened vial: Store and transport refrigerated (2°C–8°C). Do not freeze. After reconstitution and dilution: For storage conditions of the reconstituted and diluted medicinal product, see section 6.3. ...
Nature and contents of container
Type I clear glass vial with a rubber stopper (bromobutyl or chlorobutyl), containing 15 mg thiotepa. Pack size of 1 vial.
Special precautions for disposal and other handling
Preparation of TEPADINA Procedures for proper handling and disposal of anticancer medicinal products must be considered. All transfer procedures require strict adherence to aseptic techniques, preferably ...
Marketing authorization holder
ADIENNE S.r.l. S.U., Via Galileo Galilei, 19, 20867 Caponago (MB) Italy, Tel: +39-02 40700445, adienne@adienne.com
Marketing authorization number(s)
EU/1/10/622/001
Date of first authorization / renewal of the authorization
Date of first authorisation: 15 March 2010 Date of latest renewal: 15 March 2015
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