Pajjiż: Irlanda
Lingwa: Ingliż
Sors: HPRA (Health Products Regulatory Authority)
Bendamustine hydrochloride
Actavis Group PTC ehf
L01AA; L01AA09
Bendamustine hydrochloride
25 milligram(s)
Powder for concentrate for solution for infusion
Intravenous infusion
Packs of 1, 5, 10 and 20 vials. Not all pack sizes may be marketed.
Product subject to prescription which may not be renewed (A)
S.C. SINDAN-PHARMA S.R.L
Antineoplastic agents, alkylating agents
Nitrogen mustard analogues; bendamustine
First-line treatment of chronic lymphocytic leukaemia. Indolent non-Hodgkin's lymphomas. Front line treatment of multiple myeloma
Marketed
2015-05-15
1 PACKAGE LEAFLET: INFORMATION FOR THE USER BENDAMUSTINE 25 MG AND 100 MG 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 Bendamustine is and what it is used for 2. What you need to know before you use Bendamustine 3. How to use Bendamustine 4. Possible side effects 5. How to store Bendamustine 6. Contents of the pack and other information 1. WHAT BENDAMUSTINE IS AND WHAT IT IS USED FOR Bendamustine is a medicine which is used for the treatment of certain types of cancer (cytotoxic medicine). Bendamustine 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 thalidomide or bortezomib containing therapy is not appropriate for you. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE BENDAMUSTINE DO NOT USE BENDAMUSTINE: - if you are allergic to bendamustine hydrochloride or any of the other ingredients of this medicine (listed in section 6) - while breast-feeding; if treatment with Bendamustine is necessary during lactation you must discontinue breast-feeding - 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 a Aqra d-dokument sħiħ
Health Products Regulatory Authority 04 May 2021 CRN00C4WD Page 1 of 11 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Bendamustine 25 mg 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. 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 Posology _Monotherapy for chronic lymphocytic leukaemia _ 100 mg/m² body surface area bendamustine hydrochloride on days 1 and 2; every 4 weeks up to 6 times. _Monotherapy for indolent non‑Hodgkin's lymphomas refractory to rituximab _ 120 mg/m² body surface area bendamustine hydrochloride on days 1 and 2; every 3 weeks for at least 6 times. _Multiple myeloma _ 120‑150 mg/m² body surface area bendamustine hydrochloride on days 1 and 2, 60 mg/m² body surface area prednisone i.v. or per os on days 1 to 4; every 4 weeks for at least 3 times. _Hepatic impairment _ On the basis of pharmacokinetic data, no dose adjustment is necessary in patients with mild hepatic impairment (serum bilirubin Aqra d-dokument sħiħ