Krajina: Írsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
MELPHALAN HYDROCHOLORIDE
Pharmexon Consulting s.r.o
L01AA; L01AA03
MELPHALAN HYDROCHOLORIDE
50 milligram(s)
Powder and solvent for solution for injection/infusion
Nitrogen mustard analogues; melphalan
2019-08-19
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT MELPHALAN PHARMEXON 50 MG POWDER AND SOLVENT FOR SOLUTION FOR INJECTION/INFUSION melphalan 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 pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Melphalan Pharmexon is and what it is used for 2. What you need to know before you are given Melphalan Pharmexon 3. How Melphalan Pharmexon will be given 4. Possible side effects 5. How to store Melphalan Pharmexon 6. Contents of the pack and other information 1. WHAT MELPHALAN IS AND WHAT IT IS USED FOR Melphalan Pharmexon contains a medicine called melphalan. This belongs to a group of medicines called cytotoxics (also called chemotherapy). Melphalan is used to treat cancer. It works by reducing the number of abnormal cells your body makes. Melphalan Pharmexon is used for: Multiple myeloma – a type of cancer that develops from cells in the bone marrow called plasma cells. Plasma cells help to fight infection and disease by producing antibodies, Advanced cancer of the ovaries, Childhood neuroblastoma - cancer of the nervous system, Malignant melanoma – skin cancer, Soft tissue sarcoma – cancer of the muscle, fat, fibrous tissue, blood vessels, or other supporting tissue of the body. You must talk to a doctor if you do not feel better or if you feel worse. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN MELPHALAN PHARMEXON You should not be given Melphalan if any of the following apply to you. Tell your doctor if: you are allergic to melphalan or any of the other ingredients of this medicine listed in section 6, you are breast-feeding. WARNINGS AND PRECAUTIONS Before treatment with melphalan, tell your doctor if any of the fo Prečítajte si celý dokument
Health Products Regulatory Authority 20 August 2019 CRN008K5M Page 1 of 10 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Melphalan Pharmexon 50 mg powder and solvent for solution for injection/infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial of powder contains melphalan hydrochloride equivalent to 50 mg melphalan. Each vial of solvent contains 10 ml of solvent. After reconstitution, each ml of the reconstituted solution contains 5 mg melphalan. Excipient(s) with known effect: After reconstitution each vial contains 53.5 mg sodium, 0.4 g ethanol and 6.2 g propylene glycol. For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Powder and solvent for solution for injection/infusion Powder: White to pale yellow lyophilized powder Solvent: A clear colourless solution, free from visible particles pH of the reconstituted solution is between 6.0 and 7.0 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS 1. Melphalan, at conventional intravenous dose, is indicated in the treatment of multiple myeloma and advanced ovarian cancer. 2. Melphalan, at high intravenous dose, is indicated, with or without haematopoietic stem cell transplantation, for the treatment of multiple myeloma and childhood neuroblastoma. 3. Melphalan, administered by regional arterial perfusion, is indicated in the treatment of localised malignant melanoma of the extremities and localised soft tissue sarcoma of the extremities. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment with melphalan should be supervised by a physician experienced in the use of anticancer therapies. General information Melphalan is for intravenous use and regional arterial perfusion only. Melphalan should not be given without haematopoietic stem cell rescue at doses of above 140 mg/m 2 . For intravenous administration, it is recommended that melphalan is injected slowly into a fast-running infusion solution via a swabbed injection port. If direct injection into a fast-running infusion is not appropriate, melphalan may be adminis Prečítajte si celý dokument