Ország: Málta
Nyelv: angol
Forrás: Medicines Authority
bendamustine hydrochloride
Actavis Group PTC ehf
L01AA09
bendamustine hydrochloride
POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
bendamustine hydrochloride 2.5 milligram(s)/millilitre
POM
ANTINEOPLASTIC AGENTS
Withdrawn
2015-04-07
1 PACKAGE LEAFLET: INFORMATION FOR THE USER BENDISTIN 2.5 MG/ML POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION Bendamustine 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 or pharmacist. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Bendistin is and what it is used for 2. What you need to know before you use Bendistin 3. How to use Bendistin 4. Possible side effects 5. How to store Bendistin 6. Contents of the pack and other information 1. WHAT BENDISTIN IS AND WHAT IT IS USED FOR Bendistin is a medicine which is used for the treatment of certain types of cancer (cytotoxic medicine). Bendistin is used alone (monotherapy) or in combination with other medicines for the treatment of the following forms of cancer: - chronic lymphocytic leukaemia in cases where fludarabine combination chemotherapy is not appropriate for you. - non-Hodgkin’s lymphomas, which had not, or only shortly, responded to prior rituximab treatment. - Multiple myeloma in cases where highdose chemotherapy with autologous stem cell transplantation, thalidomide or bortezomib containing therapy is not appropriate for you. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE BENDISTIN DO NOT USE BENDISTIN: - if you are allergic to bendamustine hydrochloride or any of the other ingredients of this medicine (listed in section 6) - while breastfeeding - if you have severe liver dysfunction (damage to the functional cells of the liver) - if you have yellowing of the skin or whites of the eyes caused by liver or blood problems (jaundice) - if you have severely disturbed bone marrow function (bone marrow depression) and serious changes in your number of white blood cells and platelets in the blood (white blood cells and/or thrombocyte values Olvassa el a teljes dokumentumot
Page 1 of 11 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Bendistin 2.5 mg/ml powder for concentrate for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml of the concentrate contains 2.5 mg bendamustine hydrochloride when reconstituted according to section 6.6. One vial contains 25 mg bendamustine hydrochloride. One vial contains 100 mg bendamustine hydrochloride. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for concentrate for solution for infusion White to off-white lyophilisate powder 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS First-line treatment of chronic lymphocytic leukaemia (Binet stage B or C) in patients for whom fludarabine combination chemotherapy is not appropriate. Indolent non-Hodgkin's lymphomas as monotherapy in patients who have progressed during or within 6 months following treatment with rituximab or a rituximab containing regimen. Front line treatment of multiple myeloma (Durie-Salmon stage II with progress or stage III) in combination with prednisone for patients older than 65 years who are not eligible for autologous stem cell transplantation and who have clinical neuropathy at time of diagnosis precluding the use of thalidomide or bortezomib containing treatment. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Administration precautions For intravenous infusion over 30-60 minutes (see section 6.6). Infusion must be administered under the supervision of a physician qualified and experienced in the use of chemotherapeutic agents. Poor bone marrow function is related to increased chemotherapy-induced haematological toxicity. Treatment should not be started if leukocyte and/or platelet values have dropped to < 3,000 /µl or < 75,000 /µl, respectively (see section 4.3). 2 Posology _Monotherapy for chronic lymphocytic leukaemia _ 100 mg/m² body surface area bendamustine hydrochloride on days 1 and 2; every 4 weeks. _Monotherapy for indolent non-Hodgkin's lymphomas refractory to rituximab _ 120 mg/m² body surfac Olvassa el a teljes dokumentumot