Kraj: Irlandia
Język: angielski
Źródło: HPRA (Health Products Regulatory Authority)
ETOPOSIDE
Ebewe Pharma Ges.m.b.H Nfg. KG
ETOPOSIDE
20 Micromol
Concentrate for Soln for Inf
Product subject to prescription which may not be renewed (A)
Authorised
0000-00-00
11782025–04 SAASA SA SAA SAS A PACKAGELEAFLET: INFORMATION FOR THE PATIENT ETOPOSID “EBEWE” 20 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION Etoposide READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have further questions, please ask your doctor, nurse 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, nurse or pharmacist. This includes any side effects not listed in this leaflet. WHAT IS IN THIS LEAFLET 1. What Etoposid “Ebewe” is and what it is used for 2. What you need to know before you are given Etoposid “Ebewe” 3. How you are given Etoposid “Ebewe” 4. Possible side effects 5. How to store Etoposid “Ebewe” 6. Contents of the pack and other information 1. WHAT ETOPOSID “EBEWE” IS AND WHAT IT IS USED FOR Etoposid “Ebewe” is an anti-cancer medicine, in the form of a concentrate for solution for infusion (a concentrated solution which is diluted to make a solution which can be given as a slow injection via a drip). Etoposid “Ebewe” is used in the treatment of small cell lung cancer, testicular cancer and cancer of the blood-forming tissues of bone marrow (acute myelomonocytic and myelocytic leukaemia). It is often used at the same time as other anti-cancer medicines. Etoposid “Ebewe” works by interfering with the production of new DNA, which is needed to make more cells. Therefore, when Etoposid “Ebewe” 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 ETOPOSID “EBEWE” DO NOT USE ETOPOSID “EBEWE Przeczytaj cały dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Etoposide ”Ebewe” 20 mg/ml – Concentrate for solution for infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml of concentrate for solution for infusion contains 20 mg of etoposide. 1, 5, or 10 vials of 2.5 ml concentrate for solution for infusion contains 50 mg etoposide. 1, 5, or 10 vials of 5 ml concentrate for solution for infusion contains 100 mg etoposide. 1, 5, or 10 vials of 10 ml concentrate for solution for infusion contains 200 mg etoposide. 1, 5, or 10 vials of 20 ml concentrate for solution for infusion contains 400 mg etoposide. 1, 5, or 10 vials of 50 ml concentrate for solution for infusion contains 1000 mg etoposide. Excipients: Benzyl alcohol, ethanol. _For a full list of excipients, see section 6.1._ 3 PHARMACEUTICAL FORM Concentrate for solution for infusion. Clear, light yellow solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Etoposide is a antineoplastic agent for intravenous use. It can be used alone or in combination with other oncolytic agents. Available data show that etoposide may be used in treatment of small-celled lung cancer, resistant non-seminomatous testicular carcinoma, acute myelomonocytic and myelocytic leukaemia (AML, FAB subtype M4 or M5) as part of combination therapy after failure of induction chemotherapy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Etoposide should be administered only by or under the direct supervision of a qualified physician who is experienced in the use of cancer chemotherapeutic agents. Pregnant personnel should not handle chemotherapeutic agents. Method of administration Etoposid “Ebewe Etoposide is administered by slow intravenous infusion (see below). ETOPOSIDE SHOULD NOT BE GIVEN BY RAPID INTRAVENOUS INJECTION. Etoposi Przeczytaj cały dokument