Nchi: Ayalandi
Lugha: Kiingereza
Chanzo: HPRA (Health Products Regulatory Authority)
ETOPOSIDE
Cipla (EU) Limited
L01CB01
ETOPOSIDE
20 Mg/Ml
Concentrate for Soln for Inf
slow intravenous infusion
Pack sizes: 1 vial or 10 vials
Product subject to prescription which may not be renewed (A)
Cipla (EU) Limited
Podophyllotoxin derivatives
It 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).
Authorised
2015-06-26
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 side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4. 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’. This medicine contains the active substance etoposide. Etoposide belongs to a type of drugs known as podophyllotoxin derivatives. 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. This medicine is used in adults to treat variety of cancers. It can be used alone or in combination with other anti-cancer medicines to treat: • small-cell lung cancer. • acute monoblastic & acute myelomonoblastic leukaemia (cancer of the blood-forming tissues of bone marrow). • Resistant non-seminomatous testicular tumours (cancer of testis). 2. WHAT YOU NEED TO KNOW BEFORE YOU USE ETOPOSIDE DO NOT USE ETOPOSIDE • If you are allergic to etoposide, podophyllotoxines or podophyllotoxine-derivatives or any other ingredients of this medicine (listed in section 6) • If your liver is not working properly • If your bone marrow does not produce enough blood cells • If you Soma hati kamili
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 concentrate for solution for infusion contains 20 mg etoposide One 5 ml vial contains 100 mg of etoposide. Excipients with known effects: Benzyl alcohol: 30mg/ml Ethanol: 30.5%v/v For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Concentrate for solution for infusion. A clear colourless to pale yellow sterile non-aqueous solution pH : 3.00-4.00 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. Etoposide is intended for slow intravenous infusion. Etoposide should not be administered as a rapid intravenous injection. 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 days intervals. Repeated courses of treatment with etoposide infusion must not be given before the blood picture has been controlled for signs of HEALTH PRODUCTS REGULATORY Soma hati kamili