País: Irlanda
Idioma: inglés
Fuente: HPRA (Health Products Regulatory Authority)
Epirubicin hydrochloride
Actavis Group hf
L01DB; L01DB03
Epirubicin hydrochloride
2 milligram(s)/millilitre
Solution for injection
Product subject to prescription which may not be renewed (A)
Anthracyclines and related substances; epirubicin
Marketed
2008-04-18
7 PACKAGE LEAFLET: INFORMATION FOR THE USER EPIRUBICIN 2 MG/ML SOLUTION FOR INJECTION Epirubicin hydrochloride 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. - 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. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Epirubicin is and what it is used for 2. What you need to know before you use Epirubicin 3. How to use Epirubicin 4. Possible side effects 5. How to store Epirubicin 6. Contents of the pack and other information 1. WHAT EPIRUBICIN IS AND WHAT IT IS USED FOR Epirubicin is an anti-cancer medicine. Treatment with an anti-cancer medicine is sometimes called cancer chemotherapy, Epirubicin is part of a group of medicines called antrhacyclines. These act upon cells that are actively growing, to slow or stop their growth and increase the chance that the cells die. Epirubicin is used to treat a variety of cancers. The way in which it is used depends upon the type of cancer that is being treated. When injected into the bloodstream, Epirubicin is used to treat cancers of the breast, stomach and lung as well as advanced ovarian cancer. When injected into the bladder through a tube, Epirubicin is used to treat cancers of the bladder wall. It can also be used after other treatments for prevention of such cells from growing again. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE EPIRUBICIN DO NOT USE EPIRUBICIN: - if you are allergic to epirubicin hydrochloride or any of the other ingredients of this medicine (listed in section 6). - if you are allergic to other similar drugs (belonging to a group of drugs called anthracyclines, which among others include doxorubicin or daunorubicin) - if Leer el documento completo
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Epirubicin 2 mg/ml Solution for Injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each millilitre of solution for injection contains 2 mg epirubicin hydrochloride. One 5 ml vial of Epirubicin 2 mg/ML solution for injection contains 10 mg epirubicin hydrochloride equivalent to 9.35 mg epirubicin. One 10 ml vial of Epirubicin 2 mg/ml solution for injection contains 20 mg epirubicin hydrochloride equivalent to 18.7 mg epirubicin. One 25 ml vial of Epirubicin 2 mg/ml solution for injection contains 50 mg epirubicin hydrochloride equivalent to 46.75 mg epirubicin. One 50 ml vial of Epirubicin 2 mg/ml solution for injection contains 100 mg epirubicin hydrochloride equivalent to 93.5 mg epirubicin. One 100 ml vial of Epirubicin 2 mg/ml solution for injection contains 200 mg epirubicin hydrochloride equivalent to 187 mg epirubicin. Excipient with known effect: Contains sodium 3.54 mg/ml (0.154 mmol) (see section 4.4). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection. A clear red solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Epirubicin is used in the treatment of a range of neoplastic conditions including: - Carcinoma of the breast - Advanced ovarian cancer - Gastric cancer - Small cell lung cancer When administered intravesically, epirubicin has been shown to be beneficial in the treatment of: - Papillary transitional cell carcinoma of the bladder - Carcinoma-in-situ of the bladder - Prophylaxis of recurrences of superficial bladder carcinoma following transurethral resection. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Epirubicin is for intravenous or intravesical use only. Paediatric population H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ Leer el documento completo