国家: 欧盟
语言: 英文
来源: EMA (European Medicines Agency)
liraglutide
Novo Nordisk A/S
A10BJ02
liraglutide
Drugs used in diabetes
Diabetes Mellitus, Type 2
Victoza is indicated for the treatment of adults, adolescents and children aged 10 years and above with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exerciseas monotherapy when metformin is considered inappropriate due to intolerance or contraindicationsin 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.
Revision: 23
Authorised
2009-06-30
27 B. PACKAGE LEAFLET 28 PACKAGE LEAFLET: INFORMATION FOR THE USER VICTOZA 6 MG/ML SOLUTION FOR INJECTION IN PRE-FILLED PEN 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 Victoza is and what it is used for 2. What you need to know before you use Victoza 3. How to use Victoza 4. Possible side effects 5. How to store Victoza 6. Contents of the pack and other information 1. WHAT VICTOZA IS AND WHAT IT IS USED FOR Victoza contains the active substance liraglutide. It helps your body reduce your blood sugar level only when blood sugar is too high. It also slows food passage through your stomach and can help prevent heart disease. Victoza is used on its own if your blood sugar is not properly controlled by diet and exercise alone, and you cannot use metformin (another diabetes medicine). Victoza 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, sulfonylurea, sodium-glucose cotransporter 2 inhibitor (SGLT2i)) and/or insulin. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE VICTOZA DO NOT USE VICTOZA – if you are allergic to liraglutide 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 Victoza. • if you have or have had a disease of the pancreas. This medicine should not be used if you have type 1 diabetes (your body does not produce any insuli 阅读完整的文件
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Victoza 6 mg/ml solution for injection in pre-filled pen 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml of solution contains 6 mg of liraglutide*. One pre-filled pen contains 18 mg liraglutide in 3 ml. * human glucagon-like peptide-1 (GLP-1) analogue produced by recombinant DNA technology in _Saccharomyces cerevisiae._ For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. Clear and colourless or almost colourless, isotonic solution; pH=8.15. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Victoza is indicated for the treatment of adults, adolescents and children aged 10 years and above 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. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology To improve gastro-intestinal tolerability, the starting dose is 0.6 mg liraglutide daily. After at least one week, the dose should be increased to 1.2 mg. Some patients are expected to benefit from an increase in dose from 1.2 mg to 1.8 mg and based on clinical response, after at least one week, the dose can be increased to 1.8 mg to further improve glycaemic control. Daily doses higher than 1.8 mg are not recommended. When Victoza is added to a sulfonylurea or insulin, a reduction in the dose of sulfonylurea or insulin should be considered to reduce the risk of hypoglycaemia (see section 4.4). Combination therapy with sulfonylurea is only valid for adult patients. Self-monitoring of blood glucose is not needed in order to adjust the dose of Victoza. Blood glucose self-monitoring is necessary to adjust the dose of sulfonylurea and 阅读完整的文件