Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
liraglutide
Novo Nordisk A/S
A10BJ02
liraglutide
Drugs used in diabetes
Obesity; Overweight
Saxenda is indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management in adult patients with an initial Body Mass Index (BMI) of• ≥ 30 kg/m² (obese), or• ≥ 27 kg/m² to < 30 kg/m² (overweight) in the presence of at least one weight-related comorbidity such as dysglycaemia (pre-diabetes or type 2 diabetes mellitus), hypertension, dyslipidaemia or obstructive sleep apnoea.Treatment with Saxenda should be discontinued after 12 weeks on the 3.0 mg/day dose if patients have not lost at least 5% of their initial body weight.
Revision: 14
Authorised
2015-03-23
30 B. PACKAGE LEAFLET 31 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT SAXENDA 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 Saxenda is and what it is used for 2. What you need to know before you use Saxenda 3. How to use Saxenda 4. Possible side effects 5. How to store Saxenda 6. Contents of the pack and other information 1. WHAT SAXENDA IS AND WHAT IT IS USED FOR WHAT SAXENDA IS Saxenda is a weight loss medicine that contains the active substance liraglutide. It is similar to a natural occurring hormone called glucagon-like peptide-1 (GLP-1) that is released from the intestine after a meal. Saxenda works by acting on receptors in the brain that control your appetite, causing you to feel fuller and less hungry. This may help you eat less food and reduce your body weight. WHAT SAXENDA IS USED FOR Saxenda is used for weight loss in addition to diet and exercise in adults aged 18 and above who have • a BMI of 30 kg/m² or greater (obesity) or • a BMI of 27 kg/m² and less than 30 kg/m² (overweight) and weight-related health problems (such as diabetes, high blood pressure, abnormal levels of fats in the blood or breathing problems during sleep called ‘obstructive sleep apnoea’). BMI (Body Mass Index) is a measure of your weight in relation to your height. You should only continue using Saxenda if you have lost at least 5% of your initial body weight after 12 weeks on the 3.0 mg/day dose (see section 3). Cons Прочетете целия документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Saxenda 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 Adults Saxenda is indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management in adult patients with an initial Body Mass Index (BMI) of: • _≥_ 30 kg/m² (obesity), or • _≥_ 27 kg/m² to <30 kg/m² (overweight) in the presence of at least one weight-related comorbidity such as dysglycaemia (prediabetes or type 2 diabetes mellitus), hypertension, dyslipidaemia or obstructive sleep apnoea. Treatment with Saxenda should be discontinued after 12 weeks on the 3.0 mg/day dose if patients have not lost at least 5% of their initial body weight. Adolescents (≥12 years) Saxenda can be used as an adjunct to a healthy nutrition and increased physical activity for weight management in adolescent patients from the age of 12 years and above with: • obesity (BMI corresponding to ≥30 kg/m 2 for adults by international cut-off points)* and • body weight above 60 kg. Treatment with Saxenda should be discontinued and re-evaluated if patients have not lost at least 4% of their BMI or BMI z score after 12 weeks on the 3.0 mg/day or maximum tolerated dose. 3 *IOTF BMI cut-off points for obesity by sex between 12–18 years (see table 1): TABLE 1 IOTF BMI CUT-OFF POINTS FOR OBESITY BY SEX BETWEEN 12–18 YEARS AGE (YEARS) BMI CORRESPONDING TO 30 KG/M 2 FOR ADULTS BY INTERNATIONAL CUT-OFF POINTS. MALES FEMALES 12 26.02 26.67 12.5 26.43 27.24 13 26.84 27.76 13. Прочетете целия документ