Country: ইউরোপীয় ইউনিয়ন
ভাষা: ইংরেজি
সূত্র: EMA (European Medicines Agency)
Plerixafor
Sanofi B.V.
L03AX16
plerixafor
Immunostimulants,
Multiple Myeloma; Hematopoietic Stem Cell Transplantation; Lymphoma
Mozobil is indicated in combination with granulocyte-colony-stimulating factor to enhance mobilisation of haematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with lymphoma and multiple myeloma whose cells mobilise poorly.,
Revision: 23
Authorised
2009-07-30
22 B. PACKAGE LEAFLET 23 PACKAGE LEAFLET: INFORMATION FOR THE USER MOZOBIL 20 MG/ML SOLUTION FOR INJECTION Plerixafor 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. - 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 Mozobil is and what it is used for 2. What you need to know before you use Mozobil 3. How to use Mozobil 4. Possible side effects 5. How to store Mozobil 6. Contents of the pack and other information 1. WHAT MOZOBIL IS AND WHAT IT IS USED FOR Mozobil contains the active substance plerixafor which blocks a protein on the surface of blood stem cells. This protein “ties” blood stem cells to the bone marrow. Plerixafor improves the release of stem cells into the blood stream (mobilisation). The stem cells can then be collected by a machine that separates blood constituents (apheresis machine), and subsequently frozen and stored until your transplant. If mobilisation is poor, Mozobil is used to help collect blood stem cells from the patient, for collection, storage and reintroduction (transplantation), • In adults who have lymphoma (a cancer of the white blood cells) or multiple myeloma (a cancer that affects plasma cells in the bone marrow). • In children age 1 to less than 18 years of age with lymphoma or solid tumours. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE MOZOBIL DO NOT USE MOZOBIL • if you are allergic to plerixafor or any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS Talk to your doctor before using Mozobil. Tell your doctor: • if you have or have had any heart problems. • if you have kidney problems. Your doctor may adjust the dose. • if you have high white blood cell counts. • if you have low platelet counts. • if you have a history সম্পূর্ণ নথি পড়ুন
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Mozobil 20 mg/ml solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One ml of solution contains 20 mg plerixafor. Each vial contains 24 mg plerixafor in 1.2 ml solution. Excipients with known effect: Each ml contains approximately 5 mg (0.2 mmol) of sodium. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. Clear, colourless to pale yellow solution, with a pH of 6.0-7.5 and an osmolality of 260 - 320 mOsm/kg. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Adult patients Mozobil is indicated in combination with granulocyte-colony stimulating factor (G-CSF) to enhance mobilisation of haematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in adult patients with lymphoma or multiple myeloma whose cells mobilise poorly (see section 4.2). Paediatric patients (1 to less than 18 years) Mozobil is indicated in combination with G-CSF to enhance mobilisation of haematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in children with lymphoma or solid malignant tumours, either: - pre-emptively, when circulating stem cell count on the predicted day of collection after adequate mobilization with G-CSF (with or without chemotherapy) is expected to be insufficient with regards to desired hematopoietic stem cells yield, or - who previously failed to collect sufficient haematopoietic stem cells (see section 4.2). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Mozobil therapy should be initiated and supervised by a physician experienced in oncology and/or haematology. The mobilisation and apheresis procedures should be performed in collaboration with an oncology-haematology centre with acceptable experience in this field and where the monitoring of haematopoietic progenitor cells can be correctly performed. Age over 60 and/ or prior myelosuppressive chemotherapy and/or extensive prior chemot সম্পূর্ণ নথি পড়ুন