Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Dacarbazine
medac Gesellschaft für klinische Spezialpräparate mbH
L01AX; L01AX04
Dacarbazine
1000 milligram(s)
Powder for solution for infusion
Product subject to prescription which may not be renewed (A)
Other alkylating agents; dacarbazine
Marketed
1997-11-14
pal (IE) Dacarbazine medac 500 mg/1000 mg, Powder for solution for infusion National version: 08/2023 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT DACARBAZINE MEDAC 500 MG POWDER FOR SOLUTION FOR INFUSION DACARBAZINE MEDAC 1000 MG POWDER FOR SOLUTION FOR INFUSION Dacarbazine 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 Dacarbazine medac is and what it is used for 2. What you need to know before you are given Dacarbazine medac 3. How to use Dacarbazine medac 4. Possible side effects 5. How to store Dacarbazine medac 6. Contents of the pack and other information 1. WHAT DACARBAZINE MEDAC 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 medac has been prescribed by your doctor for the treatment of cancer, such as: • advanced malignant melanoma (skin cancer), • Hodgkin’s disease (cancer of the lymphatic tissue) • soft tissue sarcoma (cancer of muscles, fat, fibrous tissue, blood vessels or other supporting tissue of the body). Dacarbazine medac can be used in combination with other cytostatic agents. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN DACARBAZINE MEDAC YOU WILL NOT BE GIVEN DACARBAZINE MEDAC • 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 BREASTFEEDING . WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before you are given Dacarbazine medac. B Read the complete document
Health Products Regulatory Authority 04 March 2024 CRN00DGSC Page 1 of 10 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Dacarbazine medac 1000 mg, powder for solution for infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each single-dose vial of Dacarbazine medac 1000 mg contains 1000 mg dacarbazine (as dacarbazine citrate, formed in situ). After reconstitution and final dilution Dacarbazine medac 1000 mg contains 2.8 - 4.0 mg/ml dacarbazine. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Dacarbazine medac 1000 mg: Powder for solution for infusion. Dacarbazine medac is a white or pale yellow powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Dacarbazineis indicated for the treatment of patients with metastasised 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 Posology The use of dacarbazine should be confined to physicians experienced in oncology or haematology. The following regimes may 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/m² body surface area/day as an i.v. injection for 5 days every 3 weeks. As an alternative to an intravenous bolus injection dacarbazine can be administered as a short-term infusion (over 15 – 30 minutes). It is also possible to give 850 mg/m² body surface area on day 1 and then once every 3 weeks as intravenous infusion. HODGKIN'S DISEASE Dacarbazine is administered in a daily dose of 375 mg/m² body surface area i.v. every 15 days in combination with doxorubicin, bleomycin and vinblastine (ABVD regimen). _Adult soft-tissue sarcoma_ For adult soft tissue sarcomas dacarbazine is given in daily doses of 250 mg/m² body surface area i.v. (days 1‑5) in combination with doxorubicin every 3 weeks (ADIC regimen). Heal Read the complete document