Country: Kesatuan Eropah
Bahasa: Inggeris
Sumber: EMA (European Medicines Agency)
laronidase
Sanofi B.V.
A16AB05
laronidase
Other alimentary tract and metabolism products,
Mucopolysaccharidosis I
Aldurazyme is indicated for long-term enzyme replacement therapy in patients with a confirmed diagnosis of mucopolysaccharidosis I (MPS I; alpha-L-iduronidase deficiency) to treat the nonneurological manifestations of the disease.
Revision: 24
Authorised
2003-06-09
21 B. PACKAGE LEAFLET 22 PACKAGE LEAFLET: INFORMATION FOR THE USER ALDURAZYME 100 U/ML CONCENTRATE FOR SOLUTION FOR INFUSION Laronidase 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 your 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 Aldurazyme is and what it is used for 2. What you need to know before you are given Aldurazyme 3. How Aldurazyme is given 4. Possible side effects 5. How to store Aldurazyme 6. Contents of the pack and other information 1. WHAT ALDURAZYME IS AND WHAT IS IT USED FOR Aldurazyme is used to treat patients with MPS I disease (Mucopolysaccharidosis I). It is given to treat the non-neurological manifestations of the disease. People with MPS I disease have either a low level or no level of an enzyme called α -L-iduronidase, which breaks down specific substances (glycosaminoglycans) in the body. As a result, these substances do not get broken down and processed by the body as they should. They accumulate in many tissues in the body, which causes the symptoms of MPS I. Aldurazyme is an artificial enzyme called laronidase. This can replace the natural enzyme which is lacking in MPS I disease. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN ALDURAZYME YOU SHOULD NOT BE GIVEN ALDURAZYME If you are allergic (hypersensitive) to laronidase or any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS Talk to your doctor before using Aldurazyme. Contact your doctor immediately if treatment with Aldurazyme causes: • Allergic reactions, including anaphylaxis (a severe allergy reaction) – see Baca dokumen lengkap
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Aldurazyme 100 U/ml concentrate for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml contains 100 U (approximately 0.58 mg) of laronidase. Each vial of 5 ml contains 500 U of laronidase. The activity unit (U) is defined as the hydrolysis of one micromole of substrate (4-MUI) per minute. Laronidase is a recombinant form of human α -L-iduronidase and is produced by recombinant DNA technology using mammalian Chinese Hamster Ovary (CHO) cell culture. Excipient(s) with known effect: Each vial of 5 ml contains 1.29 mmol sodium. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Concentrate for solution for infusion. A clear to slightly opalescent, and colourless to pale yellow solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Aldurazyme is indicated for long-term enzyme replacement therapy in patients with a confirmed diagnosis of Mucopolysaccharidosis I (MPS I; α-L-iduronidase deficiency) to treat the non- neurological manifestations of the disease (see section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Aldurazyme treatment should be supervised by a physician experienced in the management of patients with MPS I or other inherited metabolic diseases. Administration of Aldurazyme should be carried out in an appropriate clinical setting where resuscitation equipment to manage medical emergencies would be readily available. Posology The recommended dosage regimen of Aldurazyme is 100 U/kg body weight administered once every week. _Paediatric population _ No dose adjustment is necessary for the paediatric population. _Elderly _ The safety and efficacy of Aldurazyme in patients older than 65 years have not been established and no dosage regimen can be recommended in these patients. 3 _Renal and hepatic impairment _ The safety and efficacy of Aldurazyme in patients with renal or hepatic insufficiency have not been evaluated and no dosage regimen can be recommended in these patients. M Baca dokumen lengkap