Šalis: Europos Sąjunga
kalba: anglų
Šaltinis: EMA (European Medicines Agency)
6-mercaptopurine monohydrate
Nova Laboratories Ireland Limited
L01BB02
mercaptopurine
Antineoplastic agents
Leukemia, Lymphoid
Xaluprine is indicated for the treatment of acute lymphoblastic leukaemia (ALL) in adults, adolescents and children.
Revision: 15
Authorised
2012-03-09
23 B. PACKAGE LEAFLET 24 PACKAGE LEAFLET: INFORMATION FOR THE USER XALUPRINE 20 MG/ML ORAL SUSPENSION mercaptopurine 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, pharmacist 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. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Xaluprine is and what it is used for 2. What you need to know before you take Xaluprine 3. How to take Xaluprine 4. Possible side effects 5. How to store Xaluprine 6. Contents of the pack and other information 1. WHAT XALUPRINE IS AND WHAT IT IS USED FOR Xaluprine contains mercaptopurine. This belongs to a group of medicines called cytotoxics (also called chemotherapy). Xaluprine is used for acute lymphoblastic leukaemia (also called acute lymphocytic leukaemia or ALL). This is a fast-growing disease which increases the number of new white blood cells. These new white blood cells are immature (not fully formed) and unable to grow and work properly. They therefore cannot fight infections and may cause bleeding. Ask your doctor if you would like more explanation about this disease. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE XALUPRINE - DO NOT TAKE XALUPRINE if you are allergic to mercaptopurine or any of the other ingredients of this medicine (listed in section 6). - DO NOT GET VACCINATED with yellow fever vaccine whilst you are taking Xaluprine because it may be fatal. WARNINGS AND PRECAUTIONS Talk to your doctor, pharmacist or nurse before taking Xaluprine - if you have been vaccinated with yellow fever vaccine - if you have kidney or liver problems, as your doctor will need to check that they are working properly. - if you have a condition w Perskaitykite visą dokumentą
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Xaluprine 20 mg/ml oral suspension 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One ml of suspension contains 20 mg mercaptopurine (as monohydrate). Excipients with known effect One ml of suspension contains 3 mg aspartame, 1 mg methyl hydroxybenzoate (as the sodium salt), 0.5 mg ethyl hydroxybenzoate (as the sodium salt) and sucrose (trace). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Oral suspension. The suspension is pink to brown in colour. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Xaluprine is indicated for the treatment of acute lymphoblastic leukaemia (ALL) in adults, adolescents and children. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Xaluprine treatment should be supervised by a physician or other healthcare professionals experienced in the management of patients with ALL. Posology The dose is governed by cautiously monitored haematotoxicity and the dose should be carefully adjusted to suit the individual patient in accordance with the employed treatment protocol. Depending on phase of treatment, starting or target doses generally vary between 25-75 mg/m 2 body surface area (BSA) per day, but should be lower in patients with reduced or absent Thiopurine Methyl Transferase (TPMT) enzyme activity (see section 4.4). 3 25 MG/M 2 50 MG/M 2 75 MG/M 2 BSA (m 2 ) Dose (mg) Volume (ml) BSA (m 2 ) Dose (mg) Volume (ml) BSA (m 2 ) Dose (mg) Volume (ml) 0.20 - 0.29 6 0.3 0.20 - 0.23 10 0.5 0.20 - 0.23 16 0.8 0.30 - 0.36 8 0.4 0.24 – 0.26 12 0.6 0.24 - 0.26 20 1.0 0.37 - 0.43 10 0.5 0.27 - 0.29 14 0.7 0.27 - 0.34 24 1.2 0.44 - 0.51 12 0.6 0.30 - 0.33 16 0.8 0.35 - 0.39 28 1.4 0.52 - 0.60 14 0.7 0.34 - 0.37 18 0.9 0.40 - 0.43 32 1.6 0.61 - 0.68 16 0.8 0.40 - 0.44 20 1.0 0.44 - 0.49 36 1.8 0.69 - 0.75 18 0.9 0.45 - 0.50 24 1.2 0.50 - 0.55 40 2.0 0.76 - 0.84 20 1.0 0.51 - 0.58 28 1.4 0.56 - 0.60 44 2.2 0.85 - 0.99 24 1.2 0.59 - 0.66 32 1.6 0.61 - 0.65 48 2.4 1.0 - 1.16 28 1.4 0.67 - 0.74 36 1.8 0.66 - 0 Perskaitykite visą dokumentą