Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: ADIENNE S.r.l. S.U., Via Galileo Galilei, 19, 20867 Caponago (MB) Italy, Tel: +39-02 40700445, adienne@adienne.com
TEPADINA 15 mg powder for concentrate for solution for infusion.
| Pharmaceutical Form |
|---|
|
Powder for concentrate for solution for infusion. White crystalline powder. |
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 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Thiotepa |
Thiotepa is a polyfunctional cytotoxic agent related chemically and pharmacologically to the nitrogen mustard. The radiomimetic action of thiotepa is believed to occur through the release of ethylene imine radicals that, as in the case of irradiation therapy, disrupt the bonds of DNA, e.g. by alkylation of guanine at the N-7, breaking the linkage between the purine base and the sugar and liberating alkylated guanine. |
| List of Excipients |
|---|
|
None. |
Type I clear glass vial with a rubber stopper (bromobutyl or chlorobutyl), containing 15 mg thiotepa.
Pack size of 1 vial.
ADIENNE S.r.l. S.U., Via Galileo Galilei, 19, 20867 Caponago (MB) Italy, Tel: +39-02 40700445, adienne@adienne.com
EU/1/10/622/001
Date of first authorisation: 15 March 2010
Date of latest renewal: 15 March 2015
| Drug | Countries | |
|---|---|---|
| TEPADINA | Austria, Canada, Cyprus, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Lithuania, Netherlands, Poland, Romania, Turkey, United Kingdom, United States |
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