FrancophonIA/ELRC3.0 huggingface dataset:
English: • Do not use Saxenda in combination with other medicines that contain GLP-1 receptor agonists
Danish: • Du må ikke bruge Saxenda, hvis du bruger andre lægemidler, der indeholder GLP-1
English: In the 56-week part of trial 1, 67.5% achieved ≥5% weight loss after 12 weeks.
Danish: Ved uge 56 i studie 1 opnåede 67,5% et vægttab på ≥5% efter 12 uger.
English: Patients with type 2 diabetes mellitus receiving liraglutide in combination with insulin and/or sulfonylurea may have an increased risk of hypoglycaemia.
Danish: Hypoglykæmi hos patienter med type 2-diabetes mellitus Patienter med type 2-diabetes mellitus, der får liraglutid i kombination med insulin og/eller sulfonylurinstof, kan have en øget risiko for hypoglykæmi.
English: Figure 3 Change from randomisation (week 0) in body weight (%) by time in trial 4
Danish: Figur 3 Ændring i legemsvægt (%) fra randomisering (uge 0) over tid i studie 4
English: This is more likely to occur at the start of treatment and may be due to being sick (vomiting), feeling sick (nausea) and diarrhoea
Danish: Dette forekommer oftest i starten af behandlingen og kan skyldes opkastning, kvalme og diarré
English: No dosage adjustment is required based on age.
Danish: Dosisjustering på grund af alder er ikke nødvendig.
English: A single dose administration of lisinopril 20 mg with liraglutide resulted in a reduction of lisinopril AUC by 15%; Cmax decreased by 27%.
Danish: Administration af en enkelt dosis på 20 mg lisinopril sammen med liraglutid resulterede i reduktion af AUC for lisinopril på 15 %, og Cmaks blev reduceret med 27 %.
English: Your doctor may adjust the dose of your diabetes medicine to prevent you from getting low blood sugar.
Danish: Din læge kan justere dosis af din diabetesmedicin for at undgå, at du får lavt blodsukker.
English: If you forget to use Saxenda
Danish: Hvis du har glemt at bruge Saxenda
English: When initiating Saxenda, it should be considered to reduce the dose of concomitantly administered insulin or insulin secretagogues (such as sulfonylureas) to reduce the risk of hypoglycaemia.
Danish: Når behandling med Saxenda initieres, skal det overvejes at reducere dosis af insulin eller βcellestimulerende midler (f.eks. sulfonylurinstoffer), der administreres samtidigt, for at mindske risikoen for hypoglykæmi.
English: The pen is designed to be used with NovoFine or NovoTwist disposable needles
Danish: Pennen er udviklet til brug med NovoFine eller NovoTwist engangsnåle
English: • To see precisely how much solution is left, use the dose counter:
Danish: • Brug dosistælleren til at se, præcist hvor meget opløsning der er tilbage:
English: Signs may include reduction in urine volume, metallic taste in mouth and easily bruising.
Danish: Symptomerne kan omfatte nedsat urinmængde, metallisk smag i munden og større tendens til blå mærker.
English: A single dose administration of digoxin 1 mg with liraglutide resulted in a reduction of digoxin AUC by 16%; Cmax decreased by 31%.
Danish: Administration af én dosis på 1 mg digoxin sammen med liraglutid resulterede i en reduktion af AUC for digoxin på 16 %, og Cmaks blev reduceret med 31 %.
English: In clinical trials for weight management, a higher rate of cholelithiasis and cholecystitis was observed in patients treated with liraglutide than in patients on placebo.
Danish: I kliniske studier for vægtkontrol blev der set en højere forekomst af cholelithiasis og cholecystitis hos patienter, der blev behandlet med liraglutid, end hos patienter, der fik placebo.
English: Do not use the pen scale.
Danish: Brug ikke penskalaen.
English: You may need medical treatment.
Danish: Tag pakningen med. Du har muligvis brug for medicinsk behandling.
English: Major adverse cardiovascular events (MACE) were adjudicated by an external independent group of experts and defined as non-fatal myocardial infarction, non-fatal stroke and cardiovascular death.
Danish: Alvorlige kardiovaskulære bivirkninger (MACE - major adverse cardiovascular events) blev fastlagt af en ekstern, uafhængig ekspertgruppe, og defineret som ikke-dødelig myokardieinfarkt, ikke-dødelig apopleksi og kardiovaskulær død.
English: No dose adjustment is required for patients with mild or moderate renal impairment (creatinine clearance ≥30 ml/min).
Danish: Dosisjustering er ikke nødvendig hos patienter med let eller moderat nedsat nyrefunktion (kreatininclearance på ≥30 ml/min).
English: In the 56-week part of trial 1, fewer patients treated with liraglutide had developed type 2 diabetes mellitus compared to patients treated with placebo (0.2% vs. 1.1%).
Danish: Ved uge 56 i studie 1 udviklede færre patienter, der blev behandlet med liraglutid, type 2-diabetes mellitus sammenlignet med patienter, der fik placebo (0,2% i forhold til 1,1 %).
English: 4 Inject your dose
Danish: 4 Injektion af dosis
English: • ≥30 kg/m² (obese), or
Danish: • ≥30 kg/m² (adipøs) eller
English: It is similar to a natural occurring hormone called glucagon-like peptide-1 (GLP-1) that is released from the intestine after a meal.
Danish: Liraglutid svarer til et naturligt forekommende hormon, der hedder glukagon-lignende peptid-1 (GLP-1) som frigøres fra tarmen efter et måltid.
English: Saxenda is unlikely to affect your ability to drive and use machines.
Danish: Saxenda påvirker ikke evnen til at føre motorkøretøj og betjene maskiner.
English: • Unscrew the needle and dispose of it carefully.
Danish: • Skru nålen af, og kassér den omhyggeligt.
English: Systolic blood pressure, mmHg
Danish: Systolisk blodtryk, mmHg
English: Among patients not concomitantly treated with sulfonylurea, 15.7% of patients treated with Saxenda and 7.6% of patients treated with placebo reported documented symptomatic hypoglycaemic events (defined as plasma glucose ≤3.9 mmol/L accompanied by symptoms).
Danish: Blandt patienter, der ikke samtidig fik sulfonylurinstof, rapporterede 15,7% af de patienter, der fik Saxenda, og 7,6% af de patienter, der fik placebo, dokumenterede symptomatiske hypoglykæmiske hændelser (defineret som plasmaglucose ≤ 3,9 mmol/l ledsaget af symptomer).
English: The change in heart rate was reversible upon discontinuation of liraglutide (see section 4.4).
Danish: Ændringen i hjertefrekvensen var reversibel efter seponering af liraglutid (se pkt.
English: Where to inject
Danish: Hvor skal du injicere
English: In this trial, documented symptomatic hypoglycaemia (defined as plasma glucose ≤3.9 mmol/L accompanied by symptoms) was reported by 47.2% of patients treated with liraglutide 3.0 mg/day and by 51.8% of patients treated with placebo.
Danish: I dette studie blev der rapporteret dokumenterede symptomatiske hypoglykæmiske hændelser (defineret som plasmaglucose ≤ 3,9 mmol/l ledsaget af symptomer) hos 47,2% af de patienter, der fik liraglutid 3 mg/dag, og hos 51,8% af de patienter, der fik placebo.
English: This may indicate a blocked or damaged needle.
Danish: Det kan være tegn på, at nålen er tilstoppet eller beskadiget.
English: Glycaemia and cardiometabolic factors Baseline Change Baseline Change HbA1c, %
Danish: Glykæmi og kardiometaboliske faktorer Baseline Ændring Baseline Ændring
English: (such as exenatide or lixisenatide).
Danish: receptoragonister (f.eks. exenatid eller lixisenatid).
English: The contraceptive effect is therefore anticipated to be unaffected when co-administered with liraglutide.
Danish: Det forventes derfor ikke, at den kontraceptive virkning påvirkes ved administration sammen med liraglutid.
English: What you need to know before you use Saxenda Do not use Saxenda
Danish: Det skal du vide, før du begynder at bruge Saxenda Brug ikke Saxenda:
English: In the 160-week part of trial 1, the primary efficacy endpoint was the proportion of patients with onset of type 2 diabetes mellitus evaluated as time to onset.
Danish: I 160 ugers behandlingsperioden af Studie 1 var det primære virkningsendepunkt andelen af patienter der blev diagnosticeret med type 2-diabetes mellitus, evalueret som tiden indtil diagnosticering.
English: An extra dose or increase in dose should not be taken to make up for the missed dose.
Danish: Der må ikke tages en dobbeltdosis eller foretages en dosisøgning som erstatning for den glemte dosis.
English: • Pull off the outer needle cap and keep it for later.
Danish: • Fjern den ydre nålehætte og gem den til senere brug.
English: If you lose substantial weight, you are at a risk of gallstones and thereby inflamed gall bladder.
Danish: Hvis du taber dig meget, har du risiko for at få galdesten og dermed betændelse i galdeblæren.
English: You may see a drop of solution at the needle tip after injecting.
Danish: Du vil måske se en dråbe opløsning på nålens spids efter injektionen.
English: Atorvastatin Cmax was decreased by 38% and median tmax was delayed from 1 h to 3 h with liraglutide.
Danish: Atorvastatins Cmaks blev reduceret med 38 %, og medianværdien for tmaks blev forsinket fra 1 time til 3 timer med liraglutid.
English: Treatment with liraglutide significantly reduced the severity of obstructive sleep apnoea as assessed by change from baseline in the AHI compared with placebo (table 6).
Danish: Liraglutid reducerede sværhedsgraden af obstruktiv søvnapnø signifikant sammenlignet med placebo, vurderet ud fra ændring fra baseline i AHI (tabel 6).
English: Talk to your doctor if you have palpitations (you feel aware of your heartbeat) or if you have feelings of a racing heartbeat while at rest during Saxenda treatment.
Danish: Tal med lægen, hvis du under behandlingen med Saxenda får hjertebanken (du bliver opmærksom på dine hjerteslag), eller hvis du har en fornemmelse af, at dit hjerte slår meget hurtigt under hvile.
English: • ≥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.
Danish: • ≥27 kg/m² til <30 kg/m² (overvægtig) og mindst en vægtrelateret komorbiditet såsom dysglykæmi (prædiabetes eller type 2-diabetes mellitus), hypertension, dyslipidæmi eller obstruktiv søvnapnø.
English: The pharmacokinetics of liraglutide was evaluated in patients with varying degree of hepatic impairment in a single-dose trial (0.75 mg).
Danish: Farmakokinetikken af liraglutid blev vurderet hos patienter med varierende grader af nedsat leverfunktion i et enkeltdosisstudie (0,75 mg).
English: • Trial 2 (SCALE Diabetes - 1922): A 56-week trial assessing body weight loss in 846 randomised (628 completers) obese and overweight patients with insufficiently controlled type 2 diabetes mellitus (HbA1c range 7-10%).
Danish: • Studie 2 (SCALE Diabetes - 1922): Et 56-ugers studie, som vurderer vægttab hos 846 randomiserede (hvoraf 628 gennemførte) adipøse og overvægtige patienter med utilstrækkeligt kontrolleret type 2-diabetes mellitus (HbA1c-interval 7-10%).
English: Waist circumference, cm
Danish: Livvidde, cm
English: There is little experience with this medicine in patients with liver problems.
Danish: Der er begrænset erfaring med dette lægemiddel hos patienter med leverproblemer.
English: Gastro-oesophageal reflux disease Abdominal pain upper
Danish: Gastroøsofageal reflukssygdom Øvre abdominalsmerter Flatulens Eruktation Abdominal distension
English: An increase in heart rate was observed with liraglutide in clinical trials (see section 5.1).
Danish: En stigning i hjertefrekvensen blev observeret med liraglutid i kliniske studier (se pkt.
English: Among patients concomitantly treated with sulfonylurea, 60.9% of patients treated with liraglutide 3.0 mg/day and 60.0% of patients treated with placebo reported documented symptomatic hypoglycaemic events.
Danish: Blandt patienter, der samtidig fik sulfonylurinstof, rapporterede 60,9% af de patienter, der fik liraglutid 3 mg/dag, og 60,0% af de patienter, der fik placebo, om dokumenterede symptomatiske hypoglykæmiske hændelser.
English: • Always keep your pen and needles out of sight and reach of others,
Danish: Yderligere vigtig information • Opbevar altid pennen og nålene ude af syne og utilgængeligt for andre,
English: The 160-week part of trial 1 assessed time to onset of type 2 diabetes in the 2,254 randomised patients with pre-diabetes (1,128 completers).
Danish: Ved uge 160 i studie 1 vurderedes tiden indtil diagnosticering af type 2-diabetes hos de 2.254 randomiserede patienter med prædiabetes (hvoraf 1.128 gennemførte).
English: Some severe allergic reactions (anaphylaxis) have been reported rarely in patients using Saxenda.
Danish: Der er i sjældne tilfælde rapporteret om alvorlige allergiske reaktioner (anafylaksi) hos patienter, der bruger Saxenda.
English: You should only continue using Saxenda if you have lost at least 5% of your initial body weight after 12 weeks on the 3 mg/day dose (see section 3).
Danish: Du må kun fortsætte med at bruge Saxenda, hvis du efter 12 uger med en dosis på 3 mg per dag har tabt mindst 5% af den legemsvægt, du havde ved starten af behandlingen (se punkt 3).
English: Keep away from the freezer compartment.
Danish: Skal holdes på afstand af køleelementet.
English: Your pen is designed to be used with NovoFine or NovoTwist disposable needles up to a length of 8 mm and as thin as 32 G.
Danish: Pennen er beregnet til brug sammen med NovoFine eller NovoTwist engangsnåle med en længde på op til 8 mm og så tynde som 32 G.
English: • a BMI of 30 kg/m² or greater (obese) or
Danish: • et BMI på 30 kg/m2 eller højere (svær overvægt) eller
English: The pen is designed to be used with NovoFine or NovoTwist disposable needles up to a length of 8 mm and as thin as 32G.
Danish: Pennen er beregnet til anvendelse sammen med NovoFine eller NovoTwist engangsnåle med en længde på op til 8 mm og så tynde som 32G.
English: ≥30 kg/m²) or with overweight (BMI ≥27 kg/m²) with dyslipidaemia and/or hypertension were stratified according to pre-diabetes status at screening and BMI at baseline (≥30 kg/m² or
Danish: (BMI ≥30 kg/m2) eller overvægt (BMI ≥27 kg/m2) og dyslipidæmi og/eller hypertension, stratificeret i forhold til prædiabetestilstand ved screening og BMI ved baseline (≥30 kg/m2 eller <30 kg/m2).
English: Saxenda Placebo Last observation carried forward (LOCF)
Danish: Saxenda Placebo Fremskrivning af sidste observation
English: Baseline values are means, changes from baseline at week 32 are estimated means (leastsquares) and treatment contrasts at week 32 are estimated treatment differences (95% CI).
Danish: Baseline-værdierne er gennemsnitlige, ændringer fra baseline ved uge 32 er anslåede gennemsnit (mindste kvadraters metode), og behandlingskontraster ved uge 32 er anslåede behandlingsforskelle (95 % CI).
English: Sodium hydroxide (for pH adjustment) Water for injections
Danish: Saltsyre (til pH-justering) Natriumhydroxid (til pH-justering) Vand til injektionsvæsker
English: Liraglutide does not increase energy expenditure compared to placebo.
Danish: Sammenlignet med placebo øger liraglutid ikke energiforbruget.
English: When you are not using the pen, keep the pen cap on in order to protect it from light.
Danish: Når du ikke bruger pennen, skal den opbevares med penhætten påsat for at beskytte den mod lys.
English: Contents of the pack and other information What Saxenda contains
Danish: Pakningsstørrelser og yderligere oplysninger Saxenda indeholder:
English: Figure 2 Cumulative distribution of weight change (%) after 56 weeks of treatment in trial 1 Table 5 Trial 2: Changes from baseline in body weight, glycaemia and cardiometabolic parameters at week 56
Danish: Figur 2 Akkumuleret fordeling af vægtændring (%) efter 56 ugers behandling i studie 1 Tabel 5 Studie 2: Ændringer fra baseline i legemsvægt, glykæmi og kardiometaboliske parametre ved uge 56
English: - The active substance is liraglutide.
Danish: - Aktivt stof: liraglutid.
English: Few cases of anaphylactic reactions with symptoms such as hypotension, palpitations, dyspnoea and oedema have been reported with marketed use of liraglutide.
Danish: Efter markedsføring er der blevet rapporteret få tilfælde af anafylaktiske reaktioner med symptomer som hypotension, palpitationer, dyspnø og ødem ved brug af liraglutid.
English: Liraglutide exposure was reduced in patients with renal impairment compared to individuals with normal renal function in a single-dose trial (0.75 mg).
Danish: Eksponeringen af liraglutid var reduceret hos patienter med nedsat nyrefunktion sammenlignet med forsøgspersoner med normal nyrefunktion i et enkeltdosisstudie (0,75 mg).
English: The 56-week part of trial 1 assessed body weight loss in all the 3,731 randomised patients (2,590 completers).
Danish: Ved uge 56 i studie 1 vurderedes vægttabet hos alle 3.731 randomiserede patienter (hvoraf 2.590 gennemførte).
English: As liraglutide for weight management was not investigated in subjects with mild or moderate hepatic impairment, it should be used with caution in these patients (see sections 4.2 and 5.2).
Danish: Da liraglutid ikke blev undersøgt til vægtkontrol hos personer med let eller moderat nedsat leverfunktion, skal det bruges med forsigtighed hos sådanne patienter (se pkt.
English: Liraglutide stimulates insulin secretion and lowers glucagon secretion in a glucose-dependent manner which results in a lowering of fasting and post-prandial glucose.
Danish: Liraglutid stimulerer insulinsekretionen og reducerer glucagonsekretionen glucoseafhængigt.
English: • Trial 3 (SCALE Sleep Apnoea - 3970): A 32-week trial assessing sleep apnoea severity and body weight loss in 359 randomised (276 completers) obese patients with moderate or severe obstructive sleep apnoea.
Danish: • Studie 3 (SCALE Sleep Apnoea - 3970): Et 32-ugers studie, som vurderer sværhedsgraden af søvnapnø og vægttab hos 359 randomiserede (hvoraf 276 gennemførte) adipøse patienter med moderat eller svær obstruktiv søvnapnø.
English: • Trial 4 (SCALE Maintenance - 1923): A 56-week trial assessing body weight maintenance and weight loss in 422 randomised (305 completers) obese and overweight patients with hypertension or dyslipidaemia after a preceding weight loss of ≥5% induced by a low-calorie diet.
Danish: • Studie 4 (SCALE Maintenance - 1923): Et 56-ugers studie, som vurderer vægtvedligeholdelse og vægttab hos 422 randomiserede (hvoraf 305 gennemførte) adipøse og overvægtige patienter med hypertension eller dyslipidæmi efter et forudgående vægttab på ≥5%, som var opnået via en kaloriefattig kost.
English: - The other ingredients are disodium phosphate dihydrate, propylene glycol, phenol, hydrochloric acid and sodium hydroxide (for pH adjustment) and water for injections.
Danish: - Øvrige indholdsstoffer: dinatriumphosphatdihydrat, propylenglycol, phenol, saltsyre og natriumhydroxid (til pH-justering) og vand til injektionsvæsker.
English: Dry mouth Dyspepsia Gastritis
Danish: Mundtørhed Dyspepsi Gastritis
English: Table 7 Trial 4: Changes from baseline in body weight at week 56
Danish: Tabel 7 Studie 4: Ændringer fra baseline i legemsvægt ved uge 56
English: In animal studies, peripheral administration of liraglutide led to uptake in specific brain regions involved in regulation of appetite, where liraglutide, via specific activation of the GLP1R, increased key satiety and decreased key hunger signals, thereby leading to lower body weight.
Danish: I dyrestudier førte perifer administration af liraglutid til optagelse i specifikke områder i hjernen, der er involveret i appetitregulering, hvor liraglutid via specifik aktivering af GLP
English: Saxenda is not recommended for use in patients with severe hepatic impairment and should be used cautiously in patients with mild or moderate hepatic impairment (see sections 4.4 and 5.2).
Danish: Saxenda anbefales ikke til patienter med svært nedsat leverfunktion, og bør bruges med forsigtighed hos patienter med let eller moderat nedsat leverfunktion (se pkt.
English: Saxenda should not be used in combination with another GLP-1 receptor agonist.
Danish: Patienter med type 2-diabetes mellitus Saxenda bør ikke anvendes sammen med en anden GLP-1-receptor agonist.
English: In all the long-term clinical trials with Saxenda, there were 6 MACE for patients treated with liraglutide and 10 MACE for placebo-treated patients.
Danish: Fra alle langvarige kliniske studier med Saxenda blev der rapporteret 6 MACE-hændelser hos patienter, der blev behandlet med liraglutid, og 10 MACEhændelser hos patienter, der fik placebo.
English: In patients with diabetes mellitus Saxenda must not be used as a substitute for insulin.
Danish: Hyperglykæmi hos patienter med diabetes mellitus i behandling med insulin Saxenda må ikke anvendes som erstatning for insulin til patienter med diabetes mellitus.
English: Disodium phosphate dihydrate Propylene glycol
Danish: Dinatriumphosphatdihydrat Propylenglycol
English: Saxenda 6 mg/ml injection liraglutide
Danish: Saxenda 6 mg/ml injektion liraglutid s.c. anvendelse
English: In a clinical trial in overweight or obese patients with type 2 diabetes mellitus treated with insulin and liraglutide 3.0 mg/day in combination with diet and exercise and up to 2 OADs, severe hypoglycaemia (requiring third party assistance) was reported by 1.5% of patients treated with liraglutide 3.0 mg/day.
Danish: I et klinisk studie med overvægtige eller adipøse patienter med type 2-diabetes mellitus, der blev behandlet med insulin og liraglutid 3 mg/dag kombineret med diæt og motion og op til 2 orale antidiabetika, blev der rapporteret alvorlig hypoglykæmi (som krævede assistance fra tredjepart) hos 1,5% af de patienter, der fik liraglutid 3 mg/dag.
English: In clinical trials, tachycardia was reported in 0.6% of patients treated with Saxenda and in 0.1% of patients treated with placebo.
Danish: I kliniske studier blev der rapporteret takykardi hos 0,6% af de patienter, der blev behandlet med Saxenda, og hos 0,1% af de patienter, der fik placebo.
English: Exposure associated with 3.0 mg liraglutide was found to be comparable between the children aged 7 to 11, adolescents and adult subjects, after correction for body weight.
Danish: Efter korrektion for legemsvægt var eksponeringen af 3 mg liraglutid sammenlignelig mellem børn i alderen 7 til 11 år, unge og voksne forsøgspersoner.
English: • Check the name and coloured label of your pen, to make sure that it contains Saxenda.
Danish: 1 Klargøring af pennen med en ny nål • Kontrollér navnet og den farvede etiket på pennen for at sikre dig, at den indeholder Saxenda.
English: Only doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg or 3.0 mg must be selected with the dose selector.
Danish: Kun doser på 0,6 mg, 1,2 mg, 1,8 mg, 2,4 mg eller 3,0 mg må vælges med dosisvælgeren.
English: Stop taking Saxenda and contact a doctor immediately if you experience severe pain in your upper abdomen, usually worst on the right side under the ribs.
Danish: Stop med at tage Saxenda og kontakt straks din læge, hvis du oplever stærke smerter i den øvre del af maven.
English: Excipients: disodium phosphate dihydrate, propylene glycol, phenol, hydrochloric acid/sodium hydroxide (for pH adjustment), water for injections
Danish: Indholdsstoffer: dinatriumphosphatdihydrat, propylenglycol, phenol, saltsyre/natriumhydroxid (til pHjustering), vand til injektionsvæsker
English: Other medicines and Saxenda
Danish: Brug af anden medicin sammen med Saxenda
English: If you need any further information, talk to your doctor.
Danish: Tal med lægen, hvis du har brug for flere oplysninger.
English: Very common: may affect more than 1 in 10 people
Danish: Meget almindelige: kan forekomme hos flere end 1 ud af 10 behandlede
English: • Reduced kidney function
Danish: • Nedsat nyrefunktion
English: There is little experience with this medicine in patients with kidney problems.
Danish: Der er begrænset erfaring med dette lægemiddel hos patienter med nyreproblemer.
English: In clinical trials in overweight or obese patients without type 2 diabetes mellitus treated with Saxenda in combination with diet and exercise, no severe hypoglycaemic events (requiring third party assistance) were reported.
Danish: I kliniske studier med overvægtige og adipøse patienter uden type 2-diabetes mellitus, der blev behandlet med Saxenda kombineret med diæt og motion, blev der ikke rapporteret alvorlige hypoglykæmiske hændelser (som krævede assistance fra tredjepart).
English: FAS: full analysis set.
Danish: FAS: hele analysegruppen