Страна: Мальта
Язык: английский
Источник: Medicines Authority
ETOPOSIDE
Fresenius Kabi Oncology PLC
L01CB01
ETOPOSIDE
CONCENTRATE FOR SOLUTION FOR INFUSION
ETOPOSIDE 20 mg/ml
POM
ANTINEOPLASTIC AGENTS
Authorised
2014-03-26
Page 1 of 7 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. 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 etoposide will be given 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 your 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 a type of drugs known as podophyllotoxin derivatives. Etoposide is used in adults in the treatment of small cell lung cancer, testicular cancer and cancer of the blood-forming tissues of bone marrow (acute myelomonocytic and monoblastic leukaemia). It is often used at the same time as other anti-cancer medicines. Etoposide works by interfering with the production of new DNA, which is needed to make more cells. Therefore, when etoposide is taken up by the cancer cells, it stops the growth of new cancer cells. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN ETOPOSIDE DO NOT TAKE ETOPOSIDE - if you are ALLERGIC to etoposide, podophyllotoxines or podophyllotoxine-derivatives or any other ingredients of this medici Прочитать полный документ
Page 1 of 10 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: Benzyl alcohol 30 mg/ml Ethanol: 241.4 mg/ml 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 Etoposide is indicated in adults for the management of: resistant non-seminomatous testicular tumours in combination with other chemotherapeutic agents small cell lung cancer, in combination with other chemotherapeutic agents acute monoblastic leukaemia (AML M5) and acute myelomonoblastic leukaemia (AML M4) when standard induction therapy has failed (in combination with other chemotherapeutic agents). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Etoposide should only be administered under strict observation by a doctor specialised in oncology, preferable in institutions specialised in such therapies. POSOLOGY Adults The recommended dose of etoposide is 60-120 mg/m 2 i.v. per day for 5 subsequent days. As etoposide causes myelosuppression, the course of treatment must not be repeated more often than in intervals of 10 to 20 days. For non-haematological indications courses may not be repeated more frequently than at 21 day intervals. Repeated courses of treatment with Прочитать полный документ