国: アイルランド
言語: 英語
ソース: HPRA (Health Products Regulatory Authority)
BENDAMUSTINE HYDROCHLORIDE
Fresenius Kabi Oncology Plc
L01AA09
BENDAMUSTINE HYDROCHLORIDE
100 Milligram
Pdr/Conc/Soln for Infus
Product subject to prescription which may not be renewed (A)
bendamustine
Marketed
2016-10-28
BENDAMUSTINE PACK INSERT-BORDON-IRE- 592X300 Black Font Size: 9 Pt Date: 19 June 2017 Version: 09 Final Packaging Site: Bordon Mfg. Site: Baddi-2 Font: Times New Roman Dimension: 592x300 mm Folding Size: 60x33 mm _(Outline of folding size for indication purpose only, _ _it should be removed before final printing.)_ \\fre-kp-fp01\PDD-Artworks\Europe\Bendamustine\IRE\Bendamustine Pack Insert-Bordon-IRE- 592x300.indd Form No.: SOP/PDD/014-02 Rev. 00 PACKAGE LEAFLET: INFORMATION FOR THE USER BENDAMUSTINE HCL 25MG OR 100MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION BENDAMUSTINE HYDROCHOLORIDE 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, pharmacist or nurse. 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 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 DO NOT USE BENDAMUSTINE - if you are allergic to bendamustine hydroch 完全なドキュメントを読む
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Bendamustine HCl 100 mg Powder for Concentrate for Solution for Infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One vial contains 100 mg bendamustine hydrochloride. 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 lyophilized powder or cake pH: 2.5- 3.5 Osmolality: 200- 320 mOsmol/kg 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 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). Monotherapy for chronic lymphocytic leukaemia 100 mg/m 2 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/m 2 body surface area bendamustine hydrochloride on days 1 and 2; every 完全なドキュメントを読む