Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
velmanase alfa
Chiesi Farmaceutici S.p.A.
A16AB15
velmanase alfa
Other alimentary tract and metabolism products,
alpha-Mannosidosis
Treatment of non-neurological manifestations in patients with mild to moderate alpha-mannosidosis.,
Revision: 6
Authorised
2018-03-23
25 B. PACKAGE LEAFLET 26 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT LAMZEDE 10 MG POWDER FOR SOLUTION FOR INFUSION velmanase alfa This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects. 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, nurse or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Lamzede is and what it is used for 2. What you need to know before you use Lamzede 3. How to use Lamzede 4. Possible side effects 5. How to store Lamzede 6. Contents of the pack and other information 1. WHAT LAMZEDE IS AND WHAT IT IS USED FOR Lamzede contains the active substance velmanase alfa which belongs to a group of medicines known as enzyme replacement therapies. It is used to treat patients with mild to moderate alpha-mannosidosis disease. It is given for the treatment of non-neurological symptoms of the disease. Alpha-mannosidosis disease is a rare genetic disorder caused by a lack of an enzyme named alpha-mannosidase, which is needed to break down certain sugar compounds (called ‘mannose-rich oligosaccharides’) in the body. When this enzyme is missing or does not work properly, these sugar compounds build up inside cells and cause the signs and symptoms of the disease. The typical manifestations of the disease include distinctive facial features, mental retardation, difficulty in controlling movements, difficulties in hearing and speaking, frequent infections, skeletal problems, muscle pain and weakness. Velmanase alfa is designed to replace the missing enzyme in patients with alpha-mannosidosis disease. 2. WHAT YOU NEED TO KNOW BEFORE Y Aqra d-dokument sħiħ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 1. NAME OF THE MEDICINAL PRODUCT Lamzede 10 mg powder for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One vial contains 10 mg of velmanase alfa*. After reconstitution, one mL of the solution contains 2 mg of velmanase alfa (10 mg/5 mL). For the full list of excipients, see section 6.1. *Velmanase alfa is produced in mammalian Chinese Hamster Ovary (CHO) cells using recombinant DNA technology. 3. PHARMACEUTICAL FORM Powder for solution for infusion White to off-white powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Enzyme replacement therapy for the treatment of non-neurological manifestations in patients with mild to moderate alpha-mannosidosis. See sections 4.4 and 5.1._ _ 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The treatment should be supervised by a physician experienced in the management of patients with alpha-mannosidosis or in the administration of other enzyme replacement therapies (ERT) for lysosomal storage disorder. Administration of Lamzede should be carried out by a healthcare professional with the ability to manage ERT and medical emergencies. Posology The recommended dose regimen is 1 mg/kg of body weight administered once every week by intravenous infusion at a controlled speed. The effects of treatment with velmanase alfa should be periodically evaluated and discontinuation of treatment considered in cases where no clear benefits could be observed. _Special populations _ _ _ _Elderly _ No data are available and no relevant use in elderly patients is described. _Renal or hepatic impairment _ No dose adjustment is necessary for patients with renal or hepatic impairment. 3 _Paediatric population _ No dose adjustment is necessary for the paediatric population. Method of Aqra d-dokument sħiħ