Land: Den Europæiske Union
Sprog: engelsk
Kilde: EMA (European Medicines Agency)
agalsidase beta
Sanofi B.V.
A16AB04
agalsidase beta
Other alimentary tract and metabolism products,
Fabry Disease
Fabrazyme is indicated for long-term enzyme replacement therapy in patients with a confirmed diagnosis of Fabry disease (α-galactosidase-A deficiency).
Revision: 34
Authorised
2001-08-03
25 B. PACKAGE LEAFLET 26 PACKAGE LEAFLET: INFORMATION FOR THE USER FABRAZYME 35 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION agalsidase beta 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 Fabrazyme is and what it is used for 2. What you need to know before you use Fabrazyme 3. How to use Fabrazyme 4. Possible side effects 5. How to store Fabrazyme 6. Contents of the pack and other information 1. WHAT FABRAZYME IS AND WHAT IT IS USED FOR Fabrazyme contains the active substance agalsidase beta and is used as enzyme replacement therapy in Fabry disease, where the level of -galactosidase enzyme activity is absent or lower than normal. If you suffer from Fabry disease a fat substance, called globotriaosylceramide (GL-3), is not removed from the cells of your body and starts to accumulate in the walls of the blood vessels of your organs. Fabrazyme is indicated for use as long-term enzyme replacement therapy in patients with a confirmed diagnosis of Fabry disease. Fabrazyme is indicated in adults, children and adolescents aged 8 years and older. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE FABRAZYME DO NOT USE FABRAZYME - if you are allergic to agalsidase beta or any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before using Fabrazyme. If you are treated with Fabrazyme, you may develop infusion associated reactions. An infusion- associated reaction is any side effect occurring during the infusion or until the end of the Læs hele dokumentet
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Fabrazyme 35 mg powder for concentrate for solution for infusion Fabrazyme 5 mg powder for concentrate for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Fabrazyme 35 mg powder for concentrate for solution for infusion Each vial of Fabrazyme contains a nominal value of 35 mg of agalsidase beta. After reconstitution with 7.2 ml water for injections, each vial of Fabrazyme contains 5 mg/ml (35 mg/7 ml) of agalsidase beta. The reconstituted solution must be diluted further (see section 6.6). Fabrazyme 5 mg powder for concentrate for solution for infusion Each vial of Fabrazyme contains a nominal value of 5 mg of agalsidase beta. After reconstitution with 1.1 ml water for injections, each vial of Fabrazyme contains 5 mg/ml of agalsidase beta. The reconstituted solution must be diluted further (see section 6.6). Agalsidase beta is a recombinant form of human -galactosidase A and is produced by recombinant DNA technology using a mammalian Chinese Hamster Ovary (CHO) cell culture. The amino acid sequence of the recombinant form, as well as the nucleotide sequence which encoded it, are identical to the natural form of -galactosidase A. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for concentrate for solution for infusion. White to off-white lyophilisate or powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Fabrazyme is indicated for long-term enzyme replacement therapy in patients with a confirmed diagnosis of Fabry disease (α-galactosidase A deficiency). Fabrazyme is indicated in adults, children and adolescents aged 8 years and older. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Fabrazyme treatment should be supervised by a physician experienced in the management of patients with Fabry disease or other inherited metabolic diseases. Posology The recommended dose of Fabrazyme is 1 mg/kg body weight administered once every 2 weeks as an intravenous infusion. Infusion of Fabra Læs hele dokumentet