Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
BENDAMUSTINE HYDROCHLORIDE
Medac Gesellschaft fur Klinische Spezialpraparate mbH
L01A
BENDAMUSTINE HYDROCHLORIDE
100 Milligram
Pdr/Conc/Soln for Infus
Product subject to prescription which may not be renewed (A)
ALKYLATING AGENTS
Authorised
2015-08-21
pal (IE) Bendamustine medac 25 mg, 100 mg powder for concentrate for solution for infusion National version: 04/2018 PACKAGE LEAFLET: INFORMATION FOR THE USER BENDAMUSTINE MEDAC 25 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION BENDAMUSTINE MEDAC 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 medac is and what it is used for 2. What you need to know before you use Bendamustine medac 3. How to use Bendamustine medac 4. Possible side effects 5. How to store Bendamustine medac 6. Contents of the pack and other information 1. WHAT BENDAMUSTINE MEDAC IS AND WHAT IT IS USED FOR Bendamustine medac is a medicine containing an active substance called bendamustine hydrochloride (hereafter called bendamustine). 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 high-dose 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 BENDAMUSTINE MEDAC DO NOT USE BENDAMUSTINE MEDAC:_ _ if you are allergic to bendamustine hydrochloride or any of the other ingredients of this medicine (listed in section 6). Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Bendamustine medac 100 mg powder for concentrate for solution for infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One vial contains 100 mg bendamustine hydrochloride (as bendamustine hydrochloride monohydrate). 1 ml of the concentrate contains 2.5 mg bendamustine hydrochloride when reconstituted according to section 6.6. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder for concentrate for solution for infusion White to off-white 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 cycles (see also sec. 5.1). _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, depending on response for at least 6 cycles (see also sec. 5.1). _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 a minimum of 3 cycles (for median numbers of cycles see sec. 5.1). _Hepatic impairment_ On the basis of pharmacokinetic data, no dose adjustm Read the complete document