Land: Armenië
Taal: Engels
Bron: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
melphalan
EXCELLA GmbH & Co.KG
melphalan
2mg
tablets film-coated
Prescription
1 PACKAGE LEAFLET 2 PACKAGE LEAFLET: INFORMATION FOR THE USER ALKERAN 2 MG FILM-COATED TABLETS melphalan READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 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 nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Alkeran is and what it is used for 2. What you need to know before you take Alkeran 3. How to take Alkeran 4. Possible side effects 5. How to store Alkeran 6. Contents of the pack and other information 1. WHAT ALKERAN IS AND WHAT IT IS USED FOR Alkeran tablets contain a medicine called melphalan which belongs to a group of medicines called cytotoxics (also called chemotherapy) and is used to treat certain types of cancer. It works by reducing the number of abnormal cells your body makes. Alkeran tablet 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. Advanced BREAST CANCER. POLYCYTHAEMIA RUBRA VERA - a type of blood cancer where the number of red cells in your blood increases due to uncontrolled red blood cell production in your body. This makes the blood thicken and causes blood clots, and may result in headaches, dizziness and shortness of breath. Ask your doctor if you would like more explanation about these diseases. 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 TAKE ALKERAN DO NOT TAKE ALKERAN IF: You are allergic to melphalan or any of the other ingredients of this medicine (listed in secti Lees het volledige document
1 SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE _ _ MEDICINAL PRODUCT _ _ Alkeran 2 mg Film-coated Tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION. Each tablet contains 2 mg melphalan. For a full list of excipients see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet White to off white, film-coated, round, biconvex tablets engraved 'GXEH3' on one side and an 'A' on the other. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Alkeran tablets are indicated in the treatment of: multiple myeloma; advanced ovarian adenocarcinoma. Alkeran tablets may be used in the treatment of: breast carcinoma: melphalan either alone or in combination with other drugs has a significant therapeutic effect in a proportion of patients suffering from advanced breast carcinoma. Alkeran Tablets may be used in the management of polycythaemia rubra vera. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Since melphalan is myelosuppressive, frequent blood counts are essential during therapy and the dosage should be delayed or adjusted if necessary (see section 4.4). _Thromboembolic events _ Melphalan in combination with lenalidomide and prednisone or thalidomide and prednisone or dexamethasone is associated with an increased risk of venous thromboembolism (predominantly deep vein thrombosis and pulmonary embolism). Thromboprophylaxis should be administered for at least the first 5 months of treatment especially in patients with additional thrombotic risk factors. The decision to take antithrombotic prophylactic measures should be made after careful assessment of an individual patient's underlying risk factors (see sections 4.4 and 4.8). _ _ If the patient experiences any thromboembolic events, treatment must be discontinued and standard anticoagulation therapy started. Once the patient has been stabilised on the anticoagulation treatment and any complications of the thromboembolic event have been managed, melphalan in combination with lenalidomide and prednisone or thalidomide and prednisone or dexamethasone may be resta Lees het volledige document