Land: Europäische Union
Sprache: Englisch
Quelle: EMA (European Medicines Agency)
lixisenatide
Sanofi Winthrop Industrie
A10BJ03
lixisenatide
Drugs used in diabetes, Glucagon-like peptide-1 (GLP-1) analogues
Diabetes Mellitus, Type 2
Lyxumia is indicated for the treatment of adults with type 2 diabetes mellitus to achieve glycaemic control in combination with oral glucose lowering medicinal products and/or basal insulin when these, together with diet and exercise, do not provide adequate glycaemic control.,
Revision: 19
Authorised
2013-01-31
49 B. PACKAGE LEAFLET 50 PACKAGE LEAFLET: INFORMATION FOR THE USER LYXUMIA 10 MICROGRAMS SOLUTION FOR INJECTION LYXUMIA 20 MICROGRAMS SOLUTION FOR INJECTION lixisenatide 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. See section 4. WHAT IS IN THIS LEAFLET 1. What Lyxumia is and what it is used for 2. What you need to know before you use Lyxumia 3. How to use Lyxumia 4. Possible side effects 5. How to store Lyxumia 6. Contents of the pack and other information 1. WHAT LYXUMIA IS AND WHAT IT IS USED FOR Lyxumia contains the active substance lixisenatide. It is an injectable medicine used to help your body to control your blood sugar level when it is too high. It is used in adults with type 2 diabetes. Lyxumia is used with other medicines for diabetes when they are not enough to control your blood sugar levels. These may include: • oral antidiabetics (such as metformin, pioglitazone, sulphonylurea medicines) and/or, • a basal insulin, a type of insulin which works all day. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE LYXUMIA _ _ DO NOT USE LYXUMIA - if you are allergic to lixisenatide or any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS Talk to your doctor, pharmacist or nurse before using Lyxumia if: - you have type 1 diabetes or diabetic ketoacidosis (a complication of diabetes that occurs when the body is unable to break down glucose because there is not enough insulin) since this medicine will not be right for you - you have or have had inflammation of the pancreas (pancreatitis) - yo Lesen Sie das vollständige Dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Lyxumia 10 micrograms solution for injection Lyxumia 20 micrograms solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Lyxumia 10 micrograms solution for injection Each dose (0.2 ml) contains 10 micrograms (mcg) of lixisenatide (50 mcg per ml). Lyxumia 20 micrograms solution for injection Each dose (0.2 ml) contains 20 micrograms (mcg) of lixisenatide (100 mcg per ml). Excipient(s) with known effects Each dose contains 540 micrograms of metacresol. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection (injection). Clear, colourless solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Lyxumia is indicated for the treatment of adults with type 2 diabetes mellitus to achieve glycaemic control in combination with oral glucose-lowering medicinal products and/or basal insulin when these, together, with diet and exercise, do not provide adequate glycaemic control (see sections 4.4 and 5.1 for available data on the different combinations). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _ _ Posology Starting dose: dosing is initiated at 10 mcg lixisenatide once daily for 14 days. Maintenance dose: a fixed maintenance dose of 20 mcg lixisenatide once daily is started on Day 15. For the starting dose Lyxumia 10 micrograms solution for injection is available. For the maintenance dose Lyxumia 20 micrograms solution for injection is available. When Lyxumia is added to existing metformin therapy, the current metformin dose can be continued unchanged. When Lyxumia is added to existing therapy of a sulphonylurea or a basal insulin, a reduction in the dose of the sulphonylurea or the basal insulin may be considered to reduce the risk of hypoglycaemia. Lyxumia should not be given in combination with basal insulin and a sulphonylurea due to increased risk of hypoglycaemia (see section 4.4). The use of Lyxumia does not require specific blood glucose monitoring. However, when used in combination Lesen Sie das vollständige Dokument