United States - English - NLM (National Library of Medicine)

a-s medication solutions - liraglutide (unii: 839i73s42a) (liraglutide - unii:839i73s42a) - victoza is indicated: infarction, or non-fatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease [see clinical studies ( 14.3 )] . limitations of use : victoza should not be used in patients with type 1 diabetes mellitus. victoza contains liraglutide and should not be coadministered with other liraglutide-containing products. victoza is contraindicated in patients with a personal or family history of medullary thyroid carcinoma (mtc) or in patients with multiple endocrine neoplasia syndrome type 2 (men 2). victoza is contraindicated in patients with a serious hypersensitivity reaction to liraglutide or to any of the excipients in victoza. serious hypersensitivity reactions including anaphylactic reactions and angioedema have been reported with victoza [see warnings and precautions (5.6)]. risk summary based on animal reproduction studies, there may be risks to the fetus from exposure to victoza during pregnancy. victoza should be used during pregnancy only if the potentia

United States - English - NLM (National Library of Medicine)

a-s medication solutions - liraglutide (unii: 839i73s42a) (liraglutide - unii:839i73s42a) - victoza is indicated: infarction, or non-fatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease [see clinical studies ( 14.3 )] . limitations of use : victoza should not be used in patients with type 1 diabetes mellitus. victoza contains liraglutide and should not be coadministered with other liraglutide-containing products. victoza is contraindicated in patients with a personal or family history of medullary thyroid carcinoma (mtc) or in patients with multiple endocrine neoplasia syndrome type 2 (men 2). victoza is contraindicated in patients with a serious hypersensitivity reaction to liraglutide or to any of the excipients in victoza. serious hypersensitivity reactions including anaphylactic reactions and angioedema have been reported with victoza [see warnings and precautions (5.6)]. risk summary based on animal reproduction studies, there may be risks to the fetus from exposure to victoza during pregnancy. victoza should be used during pregnancy only if the potentia

United States - English - NLM (National Library of Medicine)

a-s medication solutions - linagliptin (unii: 3x29zej4r2) (linagliptin - unii:3x29zej4r2) - tradjenta is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. limitations of use tradjenta is not recommended in patients with type 1 diabetes mellitus as it would not be effective. tradjenta has not been studied in patients with a history of pancreatitis. it is unknown whether patients with a history of pancreatitis are at an increased risk for the development of pancreatitis while using tradjenta [see warnings and precautions (5.1)]. tradjenta is contraindicated in patients with hypersensitivity to linagliptin or any of the excipients in tradjenta, reactions such as anaphylaxis, angioedema, exfoliative skin conditions, urticaria, or bronchial hyperreactivity have occurred [see warnings and precautions (5.3) and adverse reactions (6)]. risk summary the limited data with tradjenta use in pregnant women are not sufficient to inform of drug-associated risk for major birth defects and miscarriage. there are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy [see clinical considerations]. in animal reproduction studies, no adverse developmental effects were observed when linagliptin was administered to pregnant rats during the period of organogenesis at doses similar to the maximum recommended clinical dose, based on exposure [see data] . the estimated background risk of major birth defects is 6% to 10% in women with pre-gestational diabetes with a hba1c >7 and has been reported to be as high as 20% to 25% in women with hba1c >10. the estimated background risk of miscarriage for the indicated population is unknown. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. clinical considerations disease-associated maternal and/or embryo/fetal risk poorly controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis, preeclampsia, spontaneous abortions, preterm delivery, and delivery complications. poorly controlled diabetes increases the fetal risk for major birth defects, stillbirth, and macrosomia related morbidity. data animal data no adverse developmental outcome was observed when linagliptin was administered to pregnant wistar han rats and himalayan rabbits during the period of organogenesis at doses up to 240 mg/kg/day and 150 mg/kg/day, respectively. these doses represent approximately 943-times (rats) and 1,943-times (rabbits) the 5 mg maximum clinical dose, based on exposure. no adverse functional, behavioral, or reproductive outcome was observed in offspring following administration of linagliptin to wistar han rats from gestation day 6 to lactation day 21 at a dose 49-times the maximum recommended human dose, based on exposure. linagliptin crosses the placenta into the fetus following oral dosing in pregnant rats and rabbits. risk summary there is no information regarding the presence of linagliptin in human milk, the effects on the breastfed infant, or the effects on milk production. however, linagliptin is present in rat milk. therefore, the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for tradjenta and any potential adverse effects on the breastfed child from tradjenta or from the underlying maternal condition. the safety and effectiveness of tradjenta have not been established in pediatric patients. effectiveness of tradjenta was not demonstrated in a 26-week randomized, double-blind, placebo-controlled trial (nct03429543) in 157 pediatric patients aged 10 to 17 years with inadequately controlled type 2 diabetes mellitus. in linagliptin studies, 1,085 linagliptin-treated patients were 65 years of age and older and 131 patients were 75 years of age and older. in these linagliptin studies, no overall differences in safety or effectiveness of linagliptin were observed between geriatric patients and younger adult patients. no dosage adjustment is recommended for patients with renal impairment [see clinical pharmacology (12.3)]. in the tradjenta treatment arm of the carmelina trial [see clinical studies (14)] , 2,200 (63%) patients had renal impairment (egfr <60 ml/min/1.73 m2 ). approximately 20% of the population had egfr ≥45 to <60 ml/min/1.73 m2 , 28% of the population had egfr ≥30 to <45 ml/min/1.73 m2 and 15% had egfr <30 ml/min/1.73 m2 . the overall incidence of adverse reactions were generally similar between the tradjenta and placebo treatment arms. no dose adjustment is recommended for patients with hepatic impairment [see clinical pharmacology (12.3)] .

Israel - English - Ministry of Health

novo nordisk ltd., israel - liraglutide - solution for injection - liraglutide 6 mg / 1 ml - 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

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

novo nordisk pharma (malaysia) sdn. bhd. - liraglutide; insulin degludec -

European Union - English - EMA (European Medicines Agency)

novo nordisk a/s - liraglutide - diabetes mellitus, type 2 - drugs used in diabetes - 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.

European Union - English - EMA (European Medicines Agency)

boehringer ingelheim international gmbh - linagliptin - diabetes mellitus, type 2 - drugs used in diabetes - trajenta is indicated in the treatment of type 2 diabetes mellitus to improve glycaemic control in adults:as monotherapyin patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to intolerance, or contraindicated due to renal impairment.as combination therapyin combination with metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control.in combination with a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control.in combination with insulin with or without metformin, when this regimen alone, with diet and exercise, does not provide adequate glycaemic control.

New Zealand - English - Medsafe (Medicines Safety Authority)

novo nordisk pharmaceuticals ltd - liraglutide 6 mg/ml;   - solution for injection - 6 mg/ml - active: liraglutide 6 mg/ml   excipient: dibasic sodium phosphate dihydrate hydrochloric acid phenol propylene glycol sodium hydroxide water for injection - glycaemic control victoza is indicated as an adjunct to diet and exercise to improve glycaemic control in patients with type 2 diabetes mellitus.

European Union - English - EMA (European Medicines Agency)

novo nordisk a/s - liraglutide - obesity; overweight - drugs used in diabetes - 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.

New Zealand - English - Medsafe (Medicines Safety Authority)

novo nordisk pharmaceuticals ltd - liraglutide 6 mg/ml;   - solution for injection - 6 mg/ml - active: liraglutide 6 mg/ml   excipient: dibasic sodium phosphate dihydrate hydrochloric acid phenol propylene glycol sodium hydroxide water for injection - 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 or greater (obese) or · 27 kg/m2 or greater (overweight) in the presence of at least one weight related comorbidity, such as dysglycaemia (pre-diabetes and 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 a patient has not lost at least 5% of their initial body weight.