Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
Eribulin
Eisai GmbH
L01XX41
eribulin
Antineoplastic agents
Breast Neoplasms; Liposarcoma
Halaven monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have progressed after at least one chemotherapeutic regimens for advanced disease (see section 5.1). Prior therapy should have included an anthracycline and a taxane unless patients were not suitable for these treatments.Halaven is indicated for the treatment of adult patients with unresectable liposarcoma who have received prior anthracycline containing therapy (unless unsuitable) for advanced or metastatic disease (see section 5.1).
Revision: 29
Authorised
2011-03-17
26 B. PACKAGE LEAFLET 27 PACKAGE LEAFLET: INFORMATION FOR THE USER HALAVEN 0.44 MG/ML SOLUTION FOR INJECTION eribulin 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 any 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 HALAVEN is and what it is used for 2. What you need to know before you use HALAVEN 3. How to use HALAVEN 4. Possible side effects 5. How to store HALAVEN 6. Contents of the pack and other information 1. WHAT HALAVEN IS AND WHAT IT IS USED FOR HALAVEN contains the active substance eribulin and is an anti-cancer medicine which works by stopping the growth and spread of cancer cells. It is used in adults for locally advanced or metastatic breast cancer (breast cancer that has spread beyond the original tumour) when at least one other therapy has been tried but has lost its effect. It is also used in adults for advanced or metastatic liposarcoma (a type of cancer that arises from fat tissue) when previous therapy has been tried but has lost its effect. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE HALAVEN DO NOT USE HALAVEN: - if you are allergic to eribulin mesilate or any of the other ingredients of this medicine (listed in section 6). - if you are breast-feeding WARNINGS AND PRECAUTIONS Talk to your doctor or nurse before using HALAVEN: - if you have liver problems - if you have a fever or an infection - if you experience numbness, tingling, prickling sensations, sensitivity to touch or muscle weakness - if you have heart problems If any of these affects you, tell your doctor who may wish to stop treatment or reduce the dose. CHILDREN AND ADOLESCENTS Do not give this medicine to children between the ages of 0 to 18 years because it does not work. OTHER MEDICINES AND HALAVEN 28 Tell your doctor if y Прочетете целия документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT HALAVEN 0.44 mg/ml solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One ml contains eribulin mesilate equivalent to 0.44 mg eribulin. Each 2 ml vial contains eribulin mesilate equivalent to 0.88 mg eribulin. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection (injection). Clear, colourless aqueous solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS HALAVEN is indicated for the treatment of adult patients with locally advanced or metastatic breast cancer who have progressed after at least one chemotherapeutic regimen for advanced disease (see section 5.1). Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting unless patients were not suitable for these treatments. HALAVEN is indicated for the treatment of adult patients with unresectable liposarcoma who have received prior anthracycline containing therapy (unless unsuitable) for advanced or metastatic disease (see section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION HALAVEN should only be prescribed by a qualified physician experienced in the appropriate use of anti-cancer therapy. It should be administered by an appropriately qualified healthcare professional only. Posology The recommended dose of eribulin as the ready to use solution is 1.23 mg/m 2 which should be administered intravenously over 2 to 5 minutes on Days 1 and 8 of every 21-day cycle. PLEASE NOTE: In the EU the recommended dose refers to the base of the active substance (eribulin). Calculation of the individual dose to be administered to a patient must be based on the strength of the ready to use solution that contains 0.44 mg/ml eribulin and the dose recommendation of 1.23 mg/m 2 . The dose reduction recommendations shown below are also shown as the dose of eribulin to be administered based on the strength of the ready to use solution. In the pivotal trials, the corresponding publications a Прочетете целия документ