Country: Malta
Language: English
Source: Medicines Authority
EPIRUBICIN HYDROCHLORIDE
Fresenius Kabi Oncology PLC Lion Court, Farnham Road, Bordon, Hampshire, GU35 0NF, United Kingdom
L01DB03
EPIRUBICIN HYDROCHLORIDE 2 mg/ml
SOLUTION FOR INFUSION OR INJECTION
EPIRUBICIN HYDROCHLORIDE 2 mg/ml
POM
ANTINEOPLASTIC AGENTS
Withdrawn
2011-03-21
PACKAGE LEAFLET: INFORMATION FOR THE USER EPIRUBICIN HYDROCHLORIDE 2 MG/ ML SOLUTION FOR INJECTION OR INFUSION (EPIRUBICIN HYDROCHLORIDE) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS 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 EPIRUBICIN IS AND WHAT IT IS USED FOR 2. BEFORE YOU USE EPIRUBICIN 3. HOW TO USE EPIRUBICIN 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE EPIRUBICIN 6. FURTHER INFORMATION 1. WHAT EPIRUBICIN IS AND WHAT IT IS USED FOR Epirubicin belongs to the therapeutic group of antineoplastic agents (medicine against cancer). It is used either alone or in combination with other anti-cancer medicines. Epirubicin is used in the treatment of: • Breast cancer • Stomach cancer _ _ Epirubicin is also used intravesically to treat early (superficial) urinary bladder cancer and help prevent recurrence of bladder cancer after surgery.” Epirubicin is often used concomitantly with other cancer fighting medicinal products (in so-called polychemotherapy schedules). 2. BEFORE YOU USE EPIRUBICIN DO NOT USE EPIRUBICIN if you are _ALLERGIC_ (hypersensitivity) to epirubicin or any of the other ingredients of Epirubicin or to any other similar medicine (belonging to a group of medicines called anthracyclines [e.g. doxorubicin and daunorubicin] or anthracenediones) if you have fewer blood cells than normal caused by previous treatment with other antitumour drugs or by previous radiotherapy. Your doctor will check this. Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Epirubicin hydrochloride 2 mg/ml Solution for Injection or Infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of solution for injection or infusion contains 2 mg of epirubicin hydrochloride. Each vial of 5 ml contains 10 mg of epirubicin hydrochloride. Each vial of 25 ml contains 50 mg of epirubicin hydrochloride. Each vial of 50 ml contains 100 mg of epirubicin hydrochloride. Each vial of 100 ml contains 200 mg of epirubicin hydrochloride. Excipient (S): 1 ml of solution for injection or infusion contains 3.5 mg sodium. - 1 vial of 5 ml solution contains 17.7 mg sodium. - 1 vial of 25 ml solution contains 88.5 mg sodium. - 1 vial of 50 ml solution contains 177.0 mg sodium. - 1vial of 100 ml solution contains 354.1 mg sodium. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for Injection or Infusion. A 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 • Gastric 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 • Intravesical prophylaxis of recurrences of superficial bladder carcinoma following transurethral resection. For intravesical use a positive benefit-risk ratio could only be established in patients in whom live attenuated BCG is contra-indicated or inappropriate. Epirubicin hydrochloride 2 mg/ml can be used in polychemotherapy schedules. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Epirubicin is for intravenous and intravesical use only. Intravenous administration: It is advisable to give the drug via the tubing of a freely running I.V. Read the complete document