País: Malta
Língua: inglês
Origem: Medicines Authority
ETOPOSIDE
Accord Healthcare Limited
L01CB01
ETOPOSIDE
CONCENTRATE FOR SOLUTION FOR INFUSION
ETOPOSIDE 20 mg/ml
POM
ANTINEOPLASTIC AGENTS
Authorised
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 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 signs of illness are the same as yours. • If you get side effects, talk to your doctor or 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 Injection is and what it is used for. 2. What you need to know before you use Etoposide Injection. 3. How to use 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. It works by interfering production cycle of DNA and slow or stop the growth of cancer cells. Etoposide Injection is used 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). • testicular tumours (cancer of testis). 2. WHAT YOU NEED TO KNOW BEFORE YOU USE ETOPOSIDE INJECTION DO NOT USE ETOPOSIDE INJECTION • 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 are breast-feeding. • if you have a weak immune system and you are being vaccinated against yellow fever at the same time. WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist or nurse before you use Etoposide Injection: • if you have a low serum alb Leia o documento completo
Page 1 of 12 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 Etoposide Injection 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 Treatment with etoposide should be initiated by or in consultation with a qualified physician experienced in cancer chemotherapy. Page 2 of 12 Etoposide Injection 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 c Leia o documento completo