Land: Malta
Språk: engelsk
Kilde: Medicines Authority
ETOPOSIDE
Fresenius Kabi Italia S.r.l Via Camagre 41, 37063 Isola della Scala (Vr) , Italy
L01CB01
ETOPOSIDE 20 mg/ml
CONCENTRATE FOR SOLUTION FOR INFUSION
ETOPOSIDE 20 mg/ml
POM
ANTINEOPLASTIC AGENTS
Authorised
2014-03-26
Page 1 of 8 Package leaflet: Information for the user Etoposide 20 mg/ml concentrate for solution for infusion Etoposide 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 or nurse. - If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4. What is in this leaflet: 1. What etoposide is and what it is used for 2. What you need to know before you are given etoposide 3. How you will be given etoposide 4. Possible side effects 5. How to store etoposide 6. Contents of the pack and other information 1. What etoposide is and what it is used for The name of this medicine is ‘Etoposide 20 mg/ml concentrate for solution for infusion’ but in the rest of the leaflet it will be called ‘etoposide’. It contains the active ingredient etoposide. Etoposide belongs to the group of medicines called cytostatics which are used in the treatment of cancer. Etoposide is used in the treatment of certain types of cancers in adults: - testicular cancer - small cell lung cancer - cancer of the blood (acute myeloid leukaemia) - tumour in the lymphatic system (Hodgkin’s lymphoma, non-Hodgkin’s lymphoma) - reproductive system cancers (gestational trophoblastic neoplasia and ovarian cancer) Etoposide is used in the treatment of certain types of cancers in children: - cancer of the blood (acute myeloid leukaemia) - tumour in the lymphatic system (Hodgkin’s lymphoma, non-Hodgkin’s lymphoma) The exact reason why you have been prescribed etoposide is best discussed with your doctor. 2. What you need to know before you are given etoposide Do not take etoposide - if you are allergic to etoposide or any of the other ingredients of this medicine (listed in section 6). - If you are breast-feeding or planning to breast-feed - If you have recently been given a live vaccine, including Les hele dokumentet
Page 1 of 13 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Etoposide 20 mg/ml concentrate for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1 ml concentrate for solution for infusion contains 20 mg of etoposide. Each 5 ml vial contains 100 mg of etoposide. Each 10 ml vial contains 200 mg of etoposide. Each 25 ml vial contains 500 mg of etoposide. Each 50 ml vial contains 1000 mg of etoposide. Excipients with known effect: Each 1 ml contains 30 mg of benzyl alcohol. Each 1 ml contains 241,4 mg of ethanol For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Concentrate for solution for infusion. A clear, light yellow to pale yellow solution. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Testicular cancer Etoposide is indicated in combination with other approved chemotherapeutic agents for the treatment of first line, recurrent or refractory testicular cancer in adults. Small cell lung cancer Etoposide is indicated in combination with other approved chemotherapeutic agents for the treatment of small-cell lung cancer in adults. Hodgkin’s lymphoma Etoposide is indicated in combination with other approved chemotherapeutic agents for the treatment of Hodgkin’s lymphoma in adult and paediatric patients. Non-Hodgkin’s lymphoma Etoposide is indicated in combination with other approved chemotherapeutic agents for the treatment of non-Hodgkin’s lymphoma in adult and paediatric patients. Acute myeloid leukaemia Etoposide is indicated in combination with other approved chemotherapeutic agents for the treatment of acute myeloid leukaemia in adult and paediatric patients. Gestational trophoblastic neoplasia Etoposide is indicated for first line and second line therapy in combination with other approved chemotherapeutic agents for the treatment of high risk gestational trophoblastic neoplasia in adults. Page 2 of 13 Ovarian cancer Etoposide is indicated in combination with other approved chemotherapeutic agents for the treatment of non-epithelial ova Les hele dokumentet