Țară: Israel
Limbă: engleză
Sursă: Ministry of Health
LIRAGLUTIDE
NOVO NORDISK LTD., ISRAEL
A10BX07
SOLUTION FOR INJECTION
LIRAGLUTIDE 6 MG / 1 ML
S.C
Required
NOVO NORDISK A/S, DENMARK
LIRAGLUTIDE
AdultsSaxenda 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 (pre-diabetes or type 2 diabetes mellitus), hypertension or dyslipidaemia, and who have failed a previous weight management intervention. 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/m2 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. Re-evaluation should be performed periodically
2021-02-28
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986 This medicine is dispensed with a doctor’s prescription only Saxenda ® Solution for injection in pre-filled pen Active ingredient: liraglutide 6 mg/ml Inactive ingredients and allergens in the preparation: see section 2 'Important information about some of this medicine's ingredients' and section 6 'Additional information'. Read the entire leaflet carefully before you start using this medicine. This leaflet contains concise information about the medicine. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if it seems to you that their medical condition is similar to yours. _ _ 1. What is this medicine intended 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/m 2 or greater (obesity) or • a BMI of 27 to 30 kg/m 2 (overweight) and weight-related health problems (such as diabetes, high blood pressure, abnormal levels of fats in the blood) and who have failed a previous weight management intervention. BMI (Body Mass Index) is a measure of weight in relation to height. You should only continue using Saxenda if you have lost at least 5% of your initial body weight after 12 weeks of treatment with the 3.0 mg/day dose (see section 3). Consult your doctor before you continue. Saxenda can be used in addition to healthy diet and increased physical activity for weight management in adolescents aged 12 years and older with: • obesity (diagnosed by a doctor) • body weight above 60 kg You should only continue using Saxenda if you have lost at least 4% of your BMI after 12 weeks on the 3.0 mg/day dose or maximum tolerated dose (see section 3). Consult your doctor before you continue. Therapeutic group: Drugs for treatment of diabetes, glucagon-like peptide-1 (GLP-1) analogs. _ _ Saxenda is a weight loss medicine that contains the active sub Citiți documentul complet
1 1. NAME OF THE MEDICINAL PRODUCT Saxenda ® 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 (pre-diabetes or type 2 diabetes mellitus), hypertension, or dyslipidaemia and who have failed a previous weight management intervention. 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. Re- evaluation should be performed periodically. *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 2 12 26.02 26.67 12.5 26.43 27.24 13 26.84 27.76 1 Citiți documentul complet