Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
insulin degludec, liraglutide
Novo Nordisk A/S
A10
insulin degludec, liraglutide
Drugs used in diabetes
Diabetes Mellitus, Type 2
Xultophy is indicated for the treatment of adults with type-2 diabetes mellitus to improve glycaemic control in combination with oral glucose-lowering medicinal products when these alone or combined with a GLP-1 receptor agonist or basal insulin do not provide adequate glycaemic control.
Revision: 16
Authorised
2014-09-18
38 B. PACKAGE LEAFLET 39 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT XULTOPHY 100 UNITS/ML + 3.6 MG/ML SOLUTION FOR INJECTION insulin degludec + liraglutide 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 Xultophy is and what it is used for 2. What you need to know before you use Xultophy 3. How to use Xultophy 4. Possible side effects 5. How to store Xultophy 6. Contents of the pack and other information 1. WHAT XULTOPHY IS AND WHAT IT IS USED FOR WHAT XULTOPHY IS USED FOR Xultophy is used to improve blood glucose (sugar) levels in adult patients with type 2 diabetes mellitus. You have diabetes because your body: • does not make enough insulin to control the level of sugar in your blood or • is not able to use the insulin properly. HOW XULTOPHY WORKS Xultophy contains two active substances that help your body control your blood sugar: • insulin degludec – a long-acting basal insulin which lowers your blood sugar levels. • liraglutide – a ‘GLP-1 analogue’ that helps your body make more insulin during meals and lowers the amount of sugar made by your body. XULTOPHY AND ORAL MEDICINES FOR DIABETES Xultophy is used with oral medicines for diabetes (such as metformin, pioglitazone and sulfonylurea medicines). It is prescribed when these medicines (used alone or with GLP-1 treatment or with basal insulin) are not enough to control your blood sugar levels. IF YOU USE GLP-1 TREATMENT You should stop your GLP-1 treatment prior to starting on Xultophy. IF YOU USE INSULIN Przeczytaj cały dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Xultophy 100 units/mL + 3.6 mg/mL solution for injection. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 mL solution contains 100 units insulin degludec* and 3.6 mg liraglutide*. *Produced in _Saccharomyces cerevisiae _ by recombinant DNA technology. One pre-filled pen contains 3 mL equivalent to 300 units insulin degludec and 10.8 mg liraglutide. One dose step contains 1 unit of insulin degludec and 0.036 mg of liraglutide. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. Clear, colourless, isotonic solution. _ _ 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Xultophy is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus to improve glycaemic control as an adjunct to diet and exercise in addition to other oral medicinal products for the treatment of diabetes. For study results with respect to combinations, effects on glycaemic control, and the populations studied, see sections 4.4, 4.5 and 5.1. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Xultophy is given once daily by subcutaneous administration. Xultophy can be administered at any time of the day, preferably at the same time of the day. Xultophy is to be dosed in accordance with the individual patient’s needs. It is recommended to optimise glycaemic control via dose adjustment based on fasting plasma glucose. Adjustment of dose may be necessary if patients undertake increased physical activity, change their usual diet or during concomitant illness. Patients who forget a dose are advised to take it upon discovery and then resume their usual once-daily dosing schedule. A minimum of 8 hours between injections should always be ensured. This also applies when administration at the same time of the day is not possible. Xultophy is administered as dose steps. One dose step contains 1 unit of insulin degludec and 0.036 mg of liraglutide. The pre-filled pen can provide from 1 up to 50 dose Przeczytaj cały dokument