Country: Írland
Tungumál: enska
Heimild: HPRA (Health Products Regulatory Authority)
Etoposide
Teva Pharma B.V.
L01CB; L01CB01
Etoposide
20 milligram(s)/millilitre
Concentrate for solution for infusion
Product subject to prescription which may not be renewed (A)
Podophyllotoxin derivatives; etoposide
Marketed
1998-07-27
PACKAGE LEAFLET: INFORMATION FOR THE USER ETOPOSIDE-TEVA 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, pharmacist or nurse. • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. • If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. WHAT ETOPOSIDE-TEVA IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN ETOPOSIDE-TEVA 3. HOW YOU WILL BE GIVEN ETOPOSIDE-TEVA 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE ETOPOSIDE-TEVA 6. CONTENTS OF THE PACK AND OTHER INFORMATION 1. WHAT ETOPOSIDE-TEVA IS AND WHAT IT IS USED FOR The name of this medicine is Etoposide-Teva. Etoposide belongs to the group of medicines called cytostatics which are used in the treatment of cancer. Etoposide-Teva 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-Teva 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-Teva is best discussed with your doctor. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN ETOPOSIDE-TEVA DO NOT TAKE ETOPOSIDE-TEVA - if you are allergic to etoposide or any of the other ingredients of this medicine (listed in section 6). - if you have recently been given a live vaccine, inc Lestu allt skjalið
Health Products Regulatory Authority 18 November 2022 CRN00D5TQ Page 1 of 12 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Etoposide-Teva 20 mg/ml Concentrate for Solution for Infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of concentrate for solution for infusion contains etoposide 20 mg. Each 5 ml vial contains 100 mg etoposide. Each 10 ml vial contains 200 mg etoposide. Excipient with known effect Each vial with 5 ml concentrate for solution for infusion contains 1.2 g ethanol. Each vial with 10 ml concentrate for solution for infusion contains 2.4 g ethanol. This is equivalent to 241 mg/ml concentrate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Concentrate for solution for infusion. Sterile, clear, yellowish, slightly viscous concentrate. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS TESTICULAR CANCER Etoposide-Teva 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-Teva is indicated in combination with other approved chemotherapeutic agents for the treatment of small-cell lung cancer in adults. HODGKIN'S LYMPHOMA Etoposide-Teva 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-Teva 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-Teva 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-Teva 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 Etoposide-Tev Lestu allt skjalið