Quốc gia: Liên Minh Châu Âu
Ngôn ngữ: Tiếng Anh
Nguồn: EMA (European Medicines Agency)
alglucosidase alfa
Sanofi B.V.
A16AB07
alglucosidase alfa
Other alimentary tract and metabolism products,
Glycogen Storage Disease Type II
Myozyme is indicated for long-term enzyme-replacement therapy (ERT) in patients with a confirmed diagnosis of Pompe disease (acid-α-glucosidase deficiency).In patients with late-onset Pompe disease the evidence of efficacy is limited.
Revision: 25
Authorised
2006-03-28
29 B. PACKAGE LEAFLET 30 PACKAGE LEAFLET: INFORMATION FOR THE USER MYOZYME 50 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION Alglucosidase alfa 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4 WHAT IS IN THIS LEAFLET 1. What Myozyme is and what it is used for 2. What you need to know before you are given Myozyme 3. How Myozyme is given 4. Possible side effects 5. How to store Myozyme 6. Contents of the pack and other information 1. WHAT MYOZYME IS AND WHAT IT IS USED FOR Myozyme is used to treat adults, children and adolescents of all ages who have a confirmed diagnosis of Pompe disease. People with Pompe disease have low levels of an enzyme called alpha-glucosidase. This enzyme helps the body control levels of glycogen (a type of carbohydrate). Glycogen provides the body with energy, but in Pompe disease the levels of glycogen can get too high. Myozyme contains an artificial enzyme called alglucosidase alfa – this can replace the natural enzyme which is lacking in Pompe disease. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN MYOZYME DO NOT USE MYOZYME: If you have experienced life-threatening allergic (hypersensitive) reactions to alglucosidase alfa or any of the other ingredients of this medicine (listed in section 6) and re-administration of the medicine was not successful. Symptoms of life-threatening allergic reactions include, but are not limited to, low blood pressure, very fast heart rate, difficulty breathing, vomiting, facial swelling, hives or rash. WARNINGS AND PRECAUTIONS If you are treated with Myozyme, you may experience an infusion-associated reaction while you are being given the medicine or during the hours following the infusion. Such a re Đọc toàn bộ tài liệu
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Myozyme 50 mg powder for concentrate for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One vial contains 50 mg of alglucosidase alfa. After reconstitution, the solution contains 5 mg of alglucosidase alfa* per ml and after dilution, the concentration varies from 0.5 mg to 4 mg/ml. *Human acid α-glucosidase is produced in Chinese hamster ovary cells (CHO) by recombinant DNA technology. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for concentrate for solution for infusion. White to off-white powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Myozyme is indicated for long-term enzyme replacement therapy (ERT) in patients with a confirmed diagnosis of Pompe disease (acid α -glucosidase deficiency). Myozyme is indicated in adults and paediatric patients of all ages. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Myozyme treatment should be supervised by a physician experienced in the management of patients with Pompe disease or other inherited metabolic or neuromuscular diseases. Posology The recommended dose regimen of alglucosidase alfa is 20 mg/kg of body weight administered once every 2 weeks. Patient response to treatment should be routinely evaluated based on a comprehensive evaluation of all clinical manifestations of the disease. _Paediatric and older people _ There is no evidence for special considerations when Myozyme is administered to paediatric patients of all ages or older people. _ _ _Patients with renal and hepatic impairment_ The safety and efficacy of Myozyme in patients with renal or hepatic impairment have not been evaluated and no specific dose regimen can be recommended for these patients. 3 Method of administration Myozyme should be administered as an intravenous infusion. Infusions should be administered incrementally. It is recommended that the infusion begin at an initial rate of 1 mg/kg/h and be gradually increased by 2 mg/kg/h every 30 minutes if there Đọc toàn bộ tài liệu