Land: Storbritannien
Sprog: engelsk
Kilde: myHealthbox
etoposide, Ph.Eur.
Pharmachemie B.V.
L01CB0
etoposide, Ph.Eur.
20mg/ml
Concentrate for solution for infusion (to dilute).
slow intravenous infusion
One package contains 1 vial or 10 vials of Eposin
POM - Prescription Only Medicine
Gesellschaft für klinische Spezialpräparate mbH
podophyllotoxine derivatives
for the management of: - testicular tumours in combination with other chemotherapeutic agents - small cell lung cancer, in combination with other chemotherapeutic agents - monoblastic leukaemia (AML M5) and acute myelomonoblastic leukaemia (AML M4) when standard therapy has failed (in combination with other chemotherapeutic agents).
Authorised
2015-03-12
PACKAGE LEAFLET: INFORMATION FOR THE USER EPOSIN, CONCENTRATE FOR SOLUTION FOR INFUSION 20 MG/ML. etoposide READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN YOUR MEDICINE. IT PROVIDES A SUMMARY OF INFORMATION ABOUT YOUR MEDICINE. • Keep this leaflet. You may need to read it again. • If you have any further questions, please ask your doctor or pharmacist. • This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. • If any of the side effects gets serious or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What Eposin is and what it is used for 2. What you need to know before you are given Eposin 3. How to use Eposin 4. Possible side effects 5. How to store Eposin 6. Further information 1. WHAT EPOSIN IS AND WHAT IT IS USED FOR MEDICINAL PRODUCT GROUP Eposin contains the active ingredient of etoposide, which is a cancer chemotherapy drug which slows the process of cell division. Eposin belongs to a class of drugs known as podophyllotoxin derivatives; it slows or stops the growth of cancer cells in your body. USE FOR This medicinal product is used for: • Tumours of the testis in combination with other products against cancer. • A certain form of lung cancer (small cell lung cancer), in combination with other products against cancer. • Certain types of cancer of the blood (acute myelomonocytic and monocytic leukaemia; in combination with other products against cancer.) 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN EPOSIN DO NOT USE EPOSIN • if you are hypersensitive to etoposide, or one of the other ingredients of t Læs hele dokumentet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Eposin, concentrate for solution for infusion 20 mg/ml 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 vial with 5 ml concentrate for solution for infusion contains 100 mg etoposide, Ph.Eur. 1 vial with 25 ml concentrate for solution for infusion contains 500 mg etoposide, Ph.Eur. 1 ml concentrate for solution for infusion contains 20 mg etoposide. Excipients: 1 ml concentrate for solution for infusion contains 30 mg benzyl alcohol. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Concentrate for solution for infusion (to dilute). 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Etoposide is indicated for the management of: - testicular tumours in combination with other chemotherapeutic agents - small cell lung cancer, in combination with other chemotherapeutic agents - monoblastic leukaemia (AML M5) and acute myelomonoblastic leukaemia (AML M4) when standard therapy has failed (in combination with other chemotherapeutic agents). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The usual dose of etoposide, in combination with other approved chemotherapeutic agents, ranges from 100–120 mg/m²/day via continuous infusion over 30 minutes for 3–5 days, followed by a resting period of 10–20 days. Generally 3 to 4 chemotherapy cycles are administered. Dose and amount of cycles should be adjusted to the level of bone marrow suppression and the reaction of the tumour. Etoposide is administered by slow intravenous infusion. ETOPOSIDE SHOULD NOT BE GIVEN BY RAPID INTRAVENOUS INJECTION. Dose adjustments Dosage of etoposide should be modified to take into account the myelosuppressive effects of other drugs in the combination or the effects of prior X-ray therapy or chemotherapy which may have comp Læs hele dokumentet