Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
agalsidase alfa
Takeda Pharmaceuticals International AG Ireland Branch
A16AB03
agalsidase alfa
Other alimentary tract and metabolism products,
Fabry Disease
Replagal is indicated for long-term enzyme-replacement therapy in patients with a confirmed diagnosis of Fabry disease (α-galactosidase-A deficiency).
Revision: 28
Authorised
2001-08-03
22 B. PACKAGE LEAFLET 23 PACKAGE LEAFLET: INFORMATION FOR THE USER REPLAGAL 1 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION agalsidase alfa READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 Replagal is and what it is used for 2. What you need to know before you are given Replagal 3. How Replagal is given 4. Possible side effects 5. How to store Replagal 6. Contents of the pack and other information 1. WHAT REPLAGAL IS AND WHAT IT IS USED FOR The active substance in Replagal is agalsidase alfa (1 mg/ml). Agalsidase alfa is a form of the human enzyme α-galactosidase. It is produced by switching on the gene for α-galactosidase A in cells. The enzyme is then removed from the cells and made into a sterile concentrate for solution for infusion. Replagal is used to treat adult patients, as well as adolescents and children from the age of 7, with confirmed diagnosis of Fabry Disease. It is used as long-term enzyme replacement therapy when the level of enzyme in the body is absent or lower than normal as in Fabry Disease. After 6 months of therapy Replagal significantly reduced pain in patients when compared to placebo (dummy) treated patients. Replagal reduced left ventricle mass in treated patients compared to placebo treated patients. These results suggest the symptoms of the disease are improving or the disease is becoming stable. 2. WHAT YOU NEED TO KNOW BEFORE REPLAGAL IS GIVEN YOU MUST NOT BE GIVEN REPLAGAL - if you are allergic to agalsidase alfa or any of the other ingredients of this medicine (li Прочетете целия документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Replagal 1 mg/ml concentrate for solution for infusion. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml of concentrate for solution for infusion contains 1 mg of agalsidase alfa*. Each vial of 3.5 ml of concentrate contains 3.5 mg of agalsidase alfa. *agalsidase alfa is the human protein α-galactosidase A produced in a human cell line by genetic engineering technology. Excipient(s) with known effect This medicinal product contains 14.2 mg sodium per vial. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Concentrate for solution for infusion. A clear and colourless solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Replagal is indicated for long-term enzyme replacement therapy in patients with a confirmed diagnosis of Fabry Disease (α-galactosidase A deficiency). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Replagal treatment should be supervised by a physician experienced in the management of patients with Fabry Disease or other inherited metabolic diseases. Posology Replagal is administered at a dose of 0.2 mg/kg body weight every other week by intravenous infusion over 40 minutes. _Special populations_ _Elderly patients_ Studies in patients over the age of 65 years have not been performed and no dosage regimen can presently be recommended in these patients as safety and efficacy have not yet been established. _Patients with hepatic impairment_ No studies have been performed in patients with hepatic impairment. _Patients with renal impairment_ No dose adjustment is necessary in patients with renal impairment. 3 The presence of extensive renal damage (eGFR < 60mL/min) may limit the renal response to enzyme replacement therapy. Limited data are available in patients on dialysis or post-kidney transplantation, no dose adjustment is recommended. _Paediatric population_ The safety and efficacy of Replagal in children aged 0-6 years has not yet been established. Currently available data are described in s Прочетете целия документ