Land: Europeiska unionen
Språk: engelska
Källa: EMA (European Medicines Agency)
semaglutide
Novo Nordisk A/S
A10BJ06
semaglutide
Drugs used in diabetes
Diabetes Mellitus
Treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise:as monotherapy when metformin is considered inappropriate due to intolerance or contraindications;in addition to other medicinal products for the treatment of diabetes.For study results with respect to combinations, effects on glycaemic control and cardiovascular events, and the populations studied, see sections 4.4, 4.5 and 5.1.
Revision: 10
Authorised
2018-02-08
45 B. PACKAGE LEAFLET 46 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT OZEMPIC 0.25 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN semaglutide 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 Ozempic is and what it is used for 2. What you need to know before you use Ozempic 3. How to use Ozempic 4. Possible side effects 5. How to store Ozempic 6. Contents of the pack and other information 1. WHAT OZEMPIC IS AND WHAT IT IS USED FOR Ozempic contains the active substance semaglutide. It _ _ helps your body reduce your blood sugar level only when blood sugar is too high and can help prevent heart disease. Ozempic is used to treat adults (aged 18 years and older) with type 2 diabetes when diet and exercise is not enough: • on its own – when you cannot use metformin (another diabetes medicine) or • with other medicines for diabetes – when they are not enough to control your blood sugar levels. These may be medicines you take by mouth or inject such as insulin. It is important that you continue with your diet and exercise plan as told by your doctor, pharmacist or nurse. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE OZEMPIC _ _ DO NOT USE OZEMPIC • if you are allergic to semaglutide 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 this medicine. This medicine is not the same as insulin and you should not use it if: • you have type 1 diabetes – a condition where your body does no Läs hela dokumentet
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Ozempic 0.25 mg solution for injection in pre-filled pen Ozempic 0.5 mg solution for injection in pre-filled pen Ozempic 1 mg solution for injection in pre-filled pen Ozempic 2 mg solution for injection in pre-filled pen 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Ozempic 0.25 mg solution for injection One ml of solution contains 1.34 mg of semaglutide*. One pre-filled pen contains 2 mg semaglutide* in 1.5 ml solution. Each dose contains 0.25 mg of semaglutide in 0.19 ml solution. Ozempic 0.5 mg solution for injection One ml of solution contains 1.34 mg of semaglutide*. One pre-filled pen contains 2 mg semaglutide* in 1.5 ml solution. Each dose contains 0.5 mg of semaglutide in 0.37 ml solution. Ozempic 1 mg solution for injection One ml of solution contains 1.34 mg of semaglutide*. One pre-filled pen contains 4 mg semaglutide* in 3 ml solution. Each dose contains 1 mg of semaglutide in 0.74 ml solution. Ozempic 2 mg solution for injection One ml of solution contains 2.68 mg of semaglutide*. One pre-filled pen contains 8 mg semaglutide* in 3 ml solution. Each dose contains 2 mg of semaglutide in 0.74 ml solution. *Human glucagon-like peptide-1 (GLP-1) analogue produced in _Saccharomyces cerevisiae _ cells _ _ by _ _ recombinant DNA technology _._ For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection (injection). Clear and colourless or almost colourless, isotonic solution; pH=7.4. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Ozempic is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise • as monotherapy when metformin is considered inappropriate due to intolerance or contraindications • in addition to other medicinal products for the treatment of diabetes. 3 For trial results with respect to combinations, effects on glycaemic control and cardiovascular events, and the populations studied, see sections 4.4, Läs hela dokumentet