País: Reino Unido
Língua: inglês
Origem: MHRA (Medicines & Healthcare Products Regulatory Agency)
Idursulfase
Shire Pharmaceuticals Ltd
A16AB16
Idursulfase
2mg/1ml
Solution for infusion
Intravenous
No Controlled Drug Status
Valid as a prescribable product
BNF: 09081000; GTIN: 7350006499210
PACKAGE LEAFLET: INFORMATION FOR THE USER ELAPRASE 2 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION idursulfase ▼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, pharmacist or nurse. - 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. WHAT IS IN THIS LEAFLET: 1. What Elaprase is and what it is used for 2. What you need to know before you use Elaprase 3. How to use Elaprase 4. Possible side effects 5 How to store Elaprase 6. Contents of the pack and other information 1. WHAT ELAPRASE IS AND WHAT IT IS USED FOR Elaprase is used as enzyme replacement therapy to treat children and adults with Hunter syndrome (Mucopolysaccharidosis II) when the level of the enzyme iduronate-2-sulfatase in the body is lower than normal, helping improve the symptoms of the disease. If you suffer from Hunter syndrome, a carbohydrate called glycosaminoglycan which is normally broken down by your body, is not broken down and slowly accumulates in various organs in your body. This causes cells to function abnormally, thereby causing problems for various organs in your body which can lead to tissue destruction and organ malfunction and failure. Typical organs where glycosaminoglycan accumulates are spleen, liver, lungs, heart, and connective tissue. In some patients glycosaminoglycan accumulates also in the brain. Elaprase contains an active substance called idursulfase which works by acting as a replacemen Leia o documento completo
OBJECT 1 ELAPRASE 2 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION Summary of Product Characteristics Updated 15-Sep-2016 | Shire Pharmaceuticals Limited 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 Elaprase 2 mg/ml concentrate for solution for infusion 2. Qualitative and quantitative composition Each vial contains 6 mg of idursulfase. Each ml contains 2 mg of idursulfase*. Excipient with known effect Each vial contains 0.482 mmol of sodium. For the full list of excipients, see section 6.1. * idursulfase is produced by recombinant DNA technology in a continuous human cell line. 3. Pharmaceutical form Concentrate for solution for infusion (sterile concentrate). A clear to slightly opalescent, colourless solution. 4. Clinical particulars 4.1 Therapeutic indications Elaprase is indicated for the long-term treatment of patients with Hunter syndrome (Mucopolysaccharidosis II, MPS II). Heterozygous females were not studied in the clinical trials. 4.2 Posology and method of administration This treatment should be supervised by a physician or other healthcare professional experienced in the management of patients with MPS II disease or other inherited metabolic disorders. Posology Elaprase is administered at a dose of 0.5 mg/kg body weight every week by intravenous infusion over a 3 hour period, which may be gradually reduced to 1 hour if no infusion-associated reactions are observed (see section 4.4). For instruction for use, see section 6.6. Infusion at home may be considered for patients who have received several months of treatment in the clinic and who are tolerating their infusions well. Home infusions should be performed under the surveillance of a physician or other healthcare professional. Special populations _Elderly patients_ There is no clinical experience in patients over Leia o documento completo