Land: Malta
Språk: engelska
Källa: Medicines Authority
ETOPOSIDE
Accord Healthcare Ireland Ltd Euro House, Euro Business Park, Little Island Cork, T45 K857, Ireland
L01CB01
ETOPOSIDE 20 mg
CONCENTRATE FOR SOLUTION FOR INFUSION
ETOPOSIDE 20 mg
POM
ANTINEOPLASTIC AGENTS
Withdrawn
2014-06-10
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 taking 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 pharmacist. • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Etoposide Injection is and what it is used for. 2. What you need to know before you are given Etoposide Injection. 3. How you will be given Etoposide Injection. 4. Possible side effects. 5. How to store Etoposide Injection. 6. Contents of the pack and other information. 1. WHAT ETOPOSIDE INJECTION IS AND WHAT IT IS USED FOR This medicine contains the active substance etoposide.This medicine belongs to the group of medicines called cytostatics which are used in the treatment of cancer. Etoposide Injection 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 Injection 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 Injection is best discussed with your doctor. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN ETOPOSIDE INJECTION DO NOT TAKE ETOPOSIDE INJECTION • if you are allergic to etoposide or any other ingredients of this medicine (listed i Läs hela dokumentet
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Etoposide 20 mg/ml Concentrate for Solution for Infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml contains 20 mg Etoposide. Each 5 ml vial contains 100 mg of Etoposide. Each 10 ml vial contains 200 mg of Etoposide. Each 12.5 ml vial contains 250 mg of Etoposide. Each 20 ml vial contains 400 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, anhydrous: 240.64 mg/ml For full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Concentrate for Solution for infusion. The product is a clear, colourless to pale yellow solution, which is practically free from particles. pH: 3.0 - 4.0 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS TESTICULAR CANCER Etoposide injection 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 injection is indicated in combination with other approved chemotherapeutic agents for the treatment of small-cell lung cancer in adults. HODGKIN’S LYMPHOMA Etoposide injection 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 injection 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 injection 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 injection 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. OVARIAN CANCER Läs hela dokumentet