Land: Den Europæiske Union
Sprog: engelsk
Kilde: EMA (European Medicines Agency)
imiglucerase
Sanofi B.V.
A16AB02
imiglucerase
Other alimentary tract and metabolism products,
Gaucher Disease
Cerezyme (imiglucerase) is indicated for use as longterm enzyme replacement therapy in patients with a confirmed diagnosis of non-neuronopathic (Type 1) or chronic neuronopathic (Type 3) Gaucher disease who exhibit clinically significant nonneurological manifestations of the disease. The non-neurological manifestations of Gaucher disease include one or more of the following conditions:anaemia after exclusion of other causes, such as iron deficiencyThrombocytopeniaBone disease after exclusion of other causes such as Vitamin D deficiencyhepatomegaly or splenomegaly
Revision: 31
Authorised
1997-11-17
18 B. PACKAGE LEAFLET 19 PACKAGE LEAFLET: INFORMATION FOR THE USER CEREZYME 400 UNITS POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION Imiglucerase 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 Cerezyme is and what it is used for. 2. What you need to know before you are given Cerezyme. 3. How Cerezyme is given. 4. Possible side effects. 5. How Cerezyme is stored. 6. Contents of the pack and other information. 1. WHAT CEREZYME IS AND WHAT IT IS USED FOR Cerezyme contains the active substance imiglucerase and is used to treat patients who have a confirmed diagnosis of Type I or Type 3 Gaucher disease, who show signs of the disease such as: anaemia (low number of red blood cells), a tendency to bleed easily (due to low numbers of platelets – a type of blood cell), spleen or liver enlargement or bone disease. People with Gaucher disease have low levels of an enzyme called acid -glucosidase. This enzyme helps the body control levels of glucosylceramide. Glucosylceramide is a natural substance in the body, made of sugar and fat _._ In Gaucher disease glucosylceramide levels can get too high. Cerezyme is an artificial enzyme called imiglucerase - this can replace the natural enzyme acid -glucosidase which is lacking or not active enough in patients with Gaucher disease. The information in this leaflet applies to all patient groups including children, adolescents, adults and the elderly. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN CEREZYME DO NOT USE CEREZYME - if you are allergic to imiglu Læs hele dokumentet
1 _ _ ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Cerezyme 400 Units Powder for concentrate for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 400 units* of imiglucerase**. After reconstitution, the solution contains 40 units (approximately 1.0 mg) of imiglucerase per ml (400 U/10 ml). Each vial must be further diluted before use (see section 6.6). * An enzyme unit (U) is defined as the amount of enzyme that catalyses the hydrolysis of one micromole of the synthetic substrate para-nitrophenyl -D-glucopyranoside (pNP-Glc) per minute at 37°C. ** Imiglucerase is a modified form of human acid -glucosidase and is produced by recombinant DNA technology using a mammalian Chinese Hamster Ovary (CHO) cell culture, with mannose modification for targeting macrophages. Excipients with known effect: Each vial contains 41 mg of sodium. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for concentrate for solution for infusion. Cerezyme is a white to off-white powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Cerezyme (imiglucerase) is indicated for use as long-term enzyme replacement therapy in patients with a confirmed diagnosis of non-neuronopathic (Type 1) or chronic neuronopathic (Type 3) Gaucher disease who exhibit clinically significant non-neurological manifestations of the disease. The non-neurological manifestations of Gaucher disease include one or more of the following conditions: • anaemia after exclusion of other causes, such as iron deficiency • thrombocytopenia • bone disease after exclusion of other causes such as Vitamin D deficiency • hepatomegaly or splenomegaly 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Disease management should be directed by physicians knowledgeable in the treatment of Gaucher disease. Posology 3 Due to the heterogeneity and the multi-systemic nature of Gaucher disease, dosage should be individualised for each patient based on a comprehensive evaluation of all cl Læs hele dokumentet