Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
Pegunigalsidase alfa
Chiesi Farmaceutici S.p.A
A16AB20
pegunigalsidase alfa
Other alimentary tract and metabolism products,
Fabry Disease
Elfabrio is indicated for long-term enzyme replacement therapy in adult patients with a confirmed diagnosis of Fabry disease (deficiency of alpha-galactosidase).
Revision: 1
Authorised
2023-05-04
21 B. PACKAGE LEAFLET 22 PACKAGE LEAFLET: INFORMATION FOR THE USER ELFABRIO 2 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION pegunigalsidase 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 or pharmacist. - 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 pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Elfabrio is and what it is used for 2. What you need to know before you are given Elfabrio 3. How Elfabrio is given 4. Possible side effects 5. How to store Elfabrio 6. Contents of the pack and other information 1. WHAT ELFABRIO IS AND WHAT IT IS USED FOR Elfabrio contains the active substance pegunigalsidase alfa, and is used as enzyme replacement therapy in adult patients with confirmed Fabry disease. Fabry disease is a rare genetic disease that can affect many parts of the body. In patients with Fabry disease, a fat substance is not removed from the cells of their body, and builds up in the walls of blood vessels which can cause organ failure. This fat builds up in the cells of these patients because they do not have enough of an enzyme called α- galactosidase-A, the enzyme responsible for breaking it down Elfabrio is used long-term to supplement or replace this enzyme in adult patients who have confirmed Fabry disease. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN ELFABRIO _ _ DO NOT USE ELFABRIO • if you are severely allergic to pegunigalsidase alfa or any of the other ingredie Прочетете целия документ
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 Elfabrio 2 mg/mL concentrate for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 20 mg of pegunigalsidase alfa in a volume of 10 mL at a concentration of 2 mg/mL. The strength indicates the quantity of the pegunigalsidase alfa with consideration of the pegylation. Pegunigalsidase alfa is produced in tobacco cells (_Nicotiana tabacum_ BY2 cells) using recombinant DNA technology. The active substance, pegunigalsidase alfa, is a covalent conjugate of prh-alpha-GAL-A with polyethylene glycol (PEG). The potency of this medicinal product should not be compared to the one of another pegylated or non- pegylated protein of the same therapeutic class. For more information, see section 5.1. Excipient with known effect Each vial contains 48 mg sodium. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Concentrate for solution for infusion Clear, colourless, solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Elfabrio is indicated for long-term enzyme replacement therapy in adult patients with a confirmed diagnosis of Fabry disease (deficiency of alpha-galactosidase). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Elfabrio treatment must be managed by a physician experienced in the treatment of patients with Fabry disease. Appropriate medical support measures should be readily available when Elfabrio is administered to patients who have not had treatment before, or who have experienced severe hypersensitivity reactions to Elfabrio in the past. Pre-treatment with antihistamines and/or corticosteroids may be advisable for patients who had previously experienced hypersensitivity reactions to Elfabrio or to another enzyme replacement therap Прочетете целия документ