Land: Den europeiske union
Språk: engelsk
Kilde: EMA (European Medicines Agency)
thiotepa
ADIENNE S.r.l. S.U.
L01AC01
thiotepa
Antineoplastic agents
Hematopoietic Stem Cell Transplantation
In combination with other chemotherapy medicinal products:with or without total body irradiation (TBI), as conditioning treatment prior to allogeneic or autologous haematopoietic progenitor cell transplantation (HPCT) in haematological diseases in adult and paediatric patients;when high dose chemotherapy with HPCT support is appropriate for the treatment of solid tumours in adult and paediatric patients.". It is proposed that Tepadina must be prescribed by physicians experienced in conditioning treatment prior to haematopoietic progenitor cell transplantation.
Revision: 19
Authorised
2010-03-15
59 B. PACKAGE LEAFLET 60 PACKAGE LEAFLET: INFORMATION FOR THE USER TEPADINA 15 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION thiotepa READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor. - If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What TEPADINA is and what it is used for 2. What you need to know before you use TEPADINA 3. How to use TEPADINA 4. Possible side effects 5. How to store TEPADINA 6. Contents of the pack and other information 1. WHAT TEPADINA IS AND WHAT IT IS USED FOR TEPADINA contains the active substance thiotepa, which belongs to a group of medicines called alkylating agents. TEPADINA is used to prepare patients for bone marrow transplantation. It works by destroying bone marrow cells. This enables the transplantation of new bone marrow cells (haematopoietic progenitor cells), which in turn enable the body to produce healthy blood cells. TEPADINA can be used in adults and children and adolescents. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE TEPADINA DO NOT USE TEPADINA - if you are allergic to thiotepa, - if you are pregnant or think you may be pregnant, - if you are breast-feeding, - if you are receiving yellow fever vaccination, live virus and bacterial vaccines. WARNING AND PRECAUTIONS You should tell your doctor if you have: - liver or kidney problems, - heart or lung problems, - seizures/fits (epilepsy) or have had them in the past (if treated with phenytoin or fosphenytoin). Because TEPADINA destroys bone marrow cells responsible for producing blood cells, regular blood tests will be taken during treatment to check your blood cell counts. In order to prevent and manage infections, you will be given anti-infectives. TEPADINA may cause another type of cancer in the future. Your doctor will discuss this ri Les hele dokumentet
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS _ _ 2 1. NAME OF THE MEDICINAL PRODUCT TEPADINA 15 mg powder for concentrate for solution for infusion TEPADINA 100 mg powder for concentrate for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION TEPADINA 15 mg powder for concentrate for solution for infusion 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). TEPADINA 100 mg powder for concentrate for solution for infusion One vial of powder contains 100 mg thiotepa. After reconstitution with 10 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. 3. PHARMACEUTICAL FORM Powder for concentrate for solution for infusion. White crystalline powder. 4. CLINICAL PARTICULARS 4.1 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 progenitor cell transplantation (HPCT) in haematological diseases in adult and paediatric patients; • when high dose chemotherapy with HPCT support is appropriate for the treatment of solid tumours in adult and paediatric patients. 4.2 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, in combination with other chemotherapeutic medicinal products, in patients with haematological diseases or solid tumours prior to HPCT. TEPADINA posology is reported, in adult and paediatric patients, according to the type of HPCT (autologous or allogeneic) and disease. _ _ _Adults _ _ _ _AUTOLOGOUS HPCT _ _ _ _Haematological diseases _ 3 _ _ The recommended dose in haematological diseases ranges from 125 mg/m 2 /day (3.38 mg/kg/day) to 300 mg/m 2 /da Les hele dokumentet