Šalis: Airija
kalba: anglų
Šaltinis: HPRA (Health Products Regulatory Authority)
Dacarbazine
Lipomed GmbH
L01AX; L01AX04
Dacarbazine
500 milligram(s)
Powder for solution for infusion
Product subject to prescription which may not be renewed (A)
Other alkylating agents; dacarbazine
Marketed
2017-08-18
1 PACKAGE LEAFLET 2 PACKAGE LEAFLET: INFORMATION FOR THE USER DACARBAZINE LIPOMED 500 MG POWDER FOR SOLUTION FOR INFUSION Dacarbazine READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START RECEIVING 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 Dacarbazine Lipomed is and what it is used for 2. What you need to know before you receive Dacarbazine Lipomed 3. How to use Dacarbazine Lipomed 4. Possible side effects 5. How to store Dacarbazine Lipomed 6. Contents of the pack and other information 1. WHAT DACARBAZINE LIPOMED IS AND WHAT IT IS USED FOR Dacarbazine belongs to the group of medicines known as cytostatic agents. These agents influence the growth of cancer cells. Dacarbazine Lipomed has been prescribed by your doctor for the treatment of cancer, such as advanced malignant melanoma (skin cancer), advanced Hodgkin’s disease (cancer of the lymph tissue) or advanced adult soft tissue sarcoma (cancer of muscles, fat, fibrous tissue, blood vessels or other supporting tissue of the body). Dacarbazine Lipomed can be given in combination with other cytostatic agents. 2. WHAT YOU NEED TO KNOW BEFORE YOU RECEIVE DACARBAZINE LIPOMED YOU MUST NOT RECEIVE DACARBAZINE LIPOMED: • if you are allergic to dacarbazine or any of the other ingredients of this medicine (listed in section 6), • if the number of white blood cells and/or platelets in your blood is too low (leukopenia and/or thrombocytopenia), • if you have a severe liver or kidney disease, • if you are pregnant or breast-feeding, • in combination with yellow fever vaccine. WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before you are given Dacarbazine Lipomed. Before each administration you will have blood tests to check that Perskaitykite visą dokumentą
Health Products Regulatory Authority 09 August 2022 CRN00CZCV Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Dacarbazine Lipomed 500 mg powder for solution for infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each single-dose vial of Dacarbazine Lipomed 500 mg contains 500 mg dacarbazine (as dacarbazine citrate, formed _in situ_). After reconstitution of Dacarbazine Lipomed 500 mg with 50 ml of water for injections, 1 ml of solution contains 10 mg dacarbazine (see section 6.6). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder for solution for infusion. White lyophilized powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Dacarbazine Lipomed is indicated for the treatment of patients with metastasized malignant melanoma. Further indications for dacarbazine as part of a combination chemotherapy are: Advanced Hodgkin’s disease. Advanced adult soft tissue sarcomas (except mesothelioma, Kaposi sarcoma). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment with Dacarbazine Lipomed should only be carried out by physicians experienced in oncology or haematology respectively. During treatment with Dacarbazine Lipomed, frequent monitoring of blood counts as well as monitoring of hepatic and renal function are required. Since severe gastrointestinal reactions frequently occur, anti-emetic and supportive measures are advisable. Because severe gastrointestinal and haematological disturbances can occur, an extremely careful benefit-risk analysis has to be made before every course of therapy with dacarbazine. Food intake prior to administration of Dacarbazine Lipomed should be avoided to reduce the severity of nausea and vomiting. Excreta and vomit should be handled with care. Posology The following regimes can be used. For further details, see current scientific literature. _Malignant melanoma_ Dacarbazine can be administered as single agent in doses of 200 to 250 mg/m 2 body surface area/day intravenously for 5 days every 3 weeks. Dacarbazine can Perskaitykite visą dokumentą