Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
eliglustat
Sanofi B.V.
A16AX10
eliglustat
Other alimentary tract and metabolism products,
Gaucher Disease
Cerdelga is indicated for the long-term treatment of adult patients with Gaucher disease type 1 (GD1), who are CYP2D6 poor metabolisers (PMs), intermediate metabolisers (IMs) or extensive metabolisers (EMs).
Revision: 16
Authorised
2015-01-19
29 B. PACKAGE LEAFLET 30 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT CERDELGA 84 MG HARD CAPSULES eliglustat 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 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 Cerdelga is and what it is used for 2. What you need to know before you take Cerdelga 3. How to take Cerdelga 4. Possible side effects 5. How to store Cerdelga 6. Contents of the pack and other information 1. WHAT CERDELGA IS AND WHAT IT IS USED FOR Cerdelga contains the active substance eliglustat and is used for the long term treatment of adult patients with Gaucher disease type 1. Gaucher disease type 1 is a rare, inherited condition in which a substance called glucosylceramide is not effectively broken down by your body. As a result glucosylceramide builds up in your spleen, liver and bones. The build-up prevents these organs from working properly. Cerdelga contains the active substance eliglustat which decreases the production of glucosylceramide, thereby preventing its build- up. In turn this helps your affected organs to work better. People differ in the speed that their body breaks down this medicine. As a result the amount of this medicine in the blood can differ between patients which could affect how a patient would respond. Cerdelga is meant to be used in patients whose body breaks down this medicine at n Прочетете целия документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 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 Cerdelga 84 mg hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 84.4 mg of eliglustat (as tartrate). Excipient(s) with known effect: Each capsule contains 106 mg lactose (as monohydrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard capsule Capsule with pearl blue-green opaque cap and pearl white opaque body with “GZ02” printed in black on the body of the capsule. The size of the capsule is ‘size 2’ (dimensions 18.0 x 6.4 mm). 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Cerdelga is indicated for the long-term treatment of adult patients with Gaucher disease type 1 (GD1), who are CYP2D6 poor metabolisers (PMs), intermediate metabolisers (IMs) or extensive metabolisers (EMs). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _ _ Therapy with Cerdelga should be initiated and supervised by a physician knowledgeable in the management of Gaucher disease. Posology The recommended dose is 84 mg eliglustat twice daily in CYP2D6 intermediate metabolisers (IMs) and extensive metabolisers (EMs). The recommended dose is 84 mg eliglustat once daily in CYP2D6 poor metabolisers (PMs). _Missed dose _ If a dose is missed, the prescribed dose should be taken at the next scheduled time; the next dose should not be doubled. Special populations _CYP2D6 ultra-rapid metabolisers (URMs) and indeterminate metabolisers _ Eliglustat should not be used in patients who are CYP2D6 ultra-rapid metabolisers (URMs) or indeterminate metabolisers (see section 4.4). 3 _ _ _Patients with hepatic impairment_ In CYP2D6 extensive metabolisers (EMs) with severe (Child-Pugh class C) hepatic impairment, eliglustat is contraindicated (see sections 4.3 and 5. Прочетете целия документ