Country: Evrópusambandið
Tungumál: enska
Heimild: EMA (European Medicines Agency)
carmustine
medac Gesellschaft für klinische Spezialpräparate mbH
L01AD01
carmustine
Antineoplastic agents
Hodgkin Disease; Lymphoma, Non-Hodgkin
Carmustine is indicated n adults in the following malignant neoplasms as a single agent or in combination with other antineoplastic agents and/or other therapeutic measures (radiotherapy, surgery): , Brain tumours (glioblastoma, brain-stem gliomas, medulloblastoma, astrocytoma and ependymoma), brain metastases, Secondary therapy in non-Hodgkin’s lymphoma and Hodgkin’s disease, as conditioning treatment prior to autologous haematopoietic progenitor cell transplantation (HPCT) in malignant haematological diseases (Hodgkin’s disease / Non-hodgkin’s lymphoma).
Revision: 9
Authorised
2018-07-18
23 B. PACKAGE LEAFLET 24 PACKAGE LEAFLET: INFORMATION FOR THE USER CARMUSTINE MEDAC 100 MG POWDER AND SOLVENT FOR CONCENTRATE FOR SOLUTION FOR INFUSION carmustine 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, pharmacist or nurse. - If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Carmustine medac is and what it is used for 2. What you need to know before Carmustine medac is given to you 3. How to use Carmustine medac 4. Possible side effects 5. How to store Carmustine medac 6. Contents of the pack and other information 1. WHAT CARMUSTINE MEDAC IS AND WHAT IT IS USED FOR Carmustine medac is a medicine which contains carmustine. Carmustine belongs to a group of anticancer medicines known as nitrosourea that act by slowing the growth of cancer cells. Carmustine is indicated in adults in the following malignant neoplasms as a single agent or in combination with other antineoplastic agents and/or other therapeutic measures (radiotherapy, surgery): - Brain tumours (glioblastoma, Brain-stem gliomas, medulloblastoma, astrocytoma and ependymoma), brain metastases - Secondary therapy in non-Hodgkin’s lymphoma and Hodgkin’s disease - Tumours of gastrointestinal tract or digestive system tract - Malignant melanoma (skin cancer) - as conditioning treatment prior to autologous haematopoietic progenitor cell transplantation (HPCT) in malignant haematological diseases (Hodgkin’s disease / Non-hodgkin’s lymphoma). 2. WHAT YOU NEED TO KNOW BEFORE YOU USE CARMUSTINE MEDAC _ _ DO NOT USE CARMUSTINE MEDAC: - if you are allergic to carmustine or any of the other ingredients of this medicine (listed in section 6). - if you suffer from suppression of blood cell formation in the bone marrow and the number of your platelets, whi Lestu allt skjalið
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Carmustine medac 100 mg powder and solvent for concentrate for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial of powder for concentrate for solution for infusion contains 100 mg carmustine. After reconstitution and dilution (se section 6.6), one ml of solution contains 3.3 mg carmustine. Excipient with known effect Each ampoule of solvent contains 3 ml ethanol anhydrous (that is equivalent to 2.37 g). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder and solvent for concentrate for solution for infusion. Powder: white to almost white powder or lyophilisate. Solvent: colourless clear liquid. The pH and osmolarity of ready-to-use solutions for infusion are: pH 4.0 to 5.0 and 385-397mOsm/l (if diluted in glucose 50 mg/ml [5%] solution for injection), and pH 4.0 to 6.8 and 370-378mOsm/l (if diluted in sodium chloride 9 mg/ml [0.9%] solution for injection). 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Carmustine is indicated in adults in the following malignant neoplasms as a single agent or in combination with other antineoplastic agents and/or other therapeutic measures (radiotherapy, surgery): - Brain tumours (glioblastoma, Brain-stem gliomas, medulloblastoma, astrocytoma and ependymoma), brain metastases _ _ _ _ - Secondary therapy in non-Hodgkin’s lymphoma and Hodgkin’s disease _ _ _ _ - Tumours of the gastrointestinal tract, _ _ _ _ - Malignant melanoma in combination with other antineoplastic medicinal products. _ _ _ _ - as conditioning treatment prior to autologous haematopoietic progenitor cell transplantation (HPCT) in malignant haematological diseases (Hodgkin’s disease / Non-hodgkin’s lymphoma). _ _ 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Carmustine medac must be administered only by specialists experienced in the field of chemotherapy and under appropriate medical supervision 3 Posology _Initial doses _ The recommended dose of Carmustine medac as a si Lestu allt skjalið