Pays: Arménie
Langue: anglais
Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
bendamustine (bendamustine hydrochloride)
Thymoorgan Pharmazie GmbH
L01AA09
bendamustine (bendamustine hydrochloride)
100mg
powder for concentrate for solution for infusion
(1) glass vial
Prescription
Registered
2017-06-22
PACKAGE LEAFLET: INFORMATION FOR THE USER BENDAMUSTINE MOOSMANN 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 or nurse. –This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. – If you get any side effects, talk to your doctor, or 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 Moosmann is and what it is used for 2. What you need to know before you use Bendamustine Moosmann 3. How to use Bendamustine Moosmann 4. Possible side effects 5. How to store Bendamustine Moosmann 6. Contents of the pack and other information 1. WHAT BENDAMUSTINE MOOSMANN IS AND WHAT IT IS USED FOR Bendamustine Moosmann is a medicine which is used for the treatment of certain types of cancer (cytotoxic medicine). Bendamustine Moosmann is used alone (monotherapy) or in combination with other medicines for the treatment of the following forms of cancer: – chronic lymphocytic leukaemia (a type of cancer of the white blood cells) in cases where fludarabine combination chemotherapy is not appropriate for you, – non-Hodgkin’s lymphomas (cancer that begins in a type of white blood cell that normally fights infection), which had not, or only shortly, responded to prior rituximab treatment, – multiple myeloma (a cancer of the plasma cells, a type of white blood cell present in the bone marrow ) 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 MOOSMANN DO NOT USE BENDAMUSTINE MOOSMANN – if you are alle Lire le document complet
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Bendamustine Moosmann 2.5 mg/ml powder for concentrate for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 25 mg or 100 mg bendamustine hydrochloride (as bendamustine hydrochloride monohydrate). 1 ml of the concentrate contains 2.5 mg bendamustine hydrochloride (as bendamustine hydrochloride monohydrate) 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, microcrystalline 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 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). Posology _Monotherapy for chronic lymphocytic leukaemia _ 100 mg/m² body surface area bendamustine hydrochloride on days 1 and 2; every 4 weeks. 1 _Monotherapy for indolent non-Hodgkin's lymphomas refractory to rituximab _ 120 mg/m² body surface area bendamustine hydrochloride on days Lire le document complet