FrancophonIA/ELRC3.0 huggingface dataset:
English: In an open label trial comparing the efficacy and safety of Xultophy and insulin glargine 100 units/mL, both as add-on to SGLT2i ± OAD, Xultophy was superior to insulin glargine in reducing mean HbA1c after 26 weeks by 1.9% (from 8.2% to 6.3%) versus 1.7% (from 8.4% to 6.7%) with an estimated treatment difference of -0.36% [-0.50; -0.21].
Danish: I et åbent studie, som sammenlignede virkning og sikkerhed af Xultophy og insulin glargin 100 enheder/ml, begge som tillæg til SGLT2i ± OAD, var Xultophy bedre end insulin glargin til at reducere det gennemsnitlige HbA1c efter 26 uger med 1,9% (fra 8,2% til 6,3%) versus 1,7% (fra 8,4% til 6,7%) med en estimeret behandlingsforskel på -0,36% [-0,50; -0,21].
English: Therapy with GLP-1 receptor agonists should be discontinued prior to initiation of Xultophy.
Danish: Behandling med GLP-1 receptoragonister bør seponeres, inden Xultophy initieres.
English: The overall exposure of insulin degludec was equivalent following administration of Xultophy versus insulin degludec alone while the Cmax was higher by 12%.
Danish: Den samlede eksponering for insulin degludec var ækvivalent efter administration af Xultophy som ved insulin degludec alene, mens Cmax var 12% højere.
English: Compared to baseline, there was a mean reduction in body weight of 0.9 kg for Xultophy and a mean increase of 2.6 kg for patients treated with a basal-bolus regimen and the estimated treatment difference was -3.57 kg [95% CI:4.19; -2.95].
Danish: Sammenlignet med baseline var der en gennemsnitslig reduktion af kropsvægt på 0,9 kg for Xultophy og en gennemsnitlig øgning på 2,6 kg for patienter behandlet med et basal-bolus regime, og den anslåede behandlingsforskel var -3,67 kg [95% CI: -4,19; -2,95].
English: The prolonged effect of Xultophy may delay recovery from hypoglycaemia.
Danish: Den langvarige virkning af Xultophy kan forsinke normalisering af blodsukkeret efter hypoglykæmi.
English: The percentage of patients experiencing severe or blood-glucose confirmed symptomatic hypoglycaemia was 12.9% in the Xultophy group and 19.5% in the insulin glargine group (estimated treatment ratio 0.42 [95% CI: 0.23; 0.75]).
Danish: Procentdelen af patienter, som fik alvorlig eller blodglucose-bekræftet symptomatisk hypoglykæmi var 12,9% i gruppen med Xultophy og 19,5% i gruppen med insulin glargin (estimeret behandlingsratio på 0,42 [95% CI: 0,23; 0,75]).
English: One pre-filled pen contains 300 units insulin degludec and 10.8 mg liraglutide in 3 mL solution 1 mL solution contains 100 units of insulin degludec and 3.6 mg liraglutide One dose step contains 1 unit of insulin degludec and 0.036 mg of liraglutide
Danish: Én fyldt pen indeholder 300 enheder insulin degludec og 10,8 mg liraglutid i 3 ml opløsning 1 ml opløsning indeholder 100 enheder insulin degludec og 3,6 mg liraglutid Ét dosistrin indeholder 1 enhed insulin degludec og 0,036 mg liraglutid
English: Transfer from GLP-1 receptor agonist to Xultophy compared to unchanged GLP-1 receptor agonist therapy (dosed according to label) were studied in a 26-weeks randomised, open-label trial in patients with type 2 diabetes mellitus inadequately controlled on a GLP-1 receptor agonist and metformin alone (74.2%) or in combination with pioglitazone (2.5%), sulfonylurea (21.2%) or both (2.1%).
Danish: Skift fra behandling med GLP-1 receptoragonist Skift fra GLP-1-receptoragonist til Xultophy sammenlignet med uændret behandling med GLP-1 receptoragonist (dosis i henhold til den godkendte dosering), blev undersøgt i et 26-ugers randomiseret, åbent studie hos patienter med type 2-diabetes mellitus, der var utilstrækkeligt kontrolleret med en GLP-1 receptoragonist og metformin alene (74,2%) eller i kombination med pioglitazon (2,5%), sulfonylunrinstof (21,2%) eller begge dele (2,1%).
English: Transfer of patients from insulin glargine (100 units/mL) to Xultophy or intensification of insulin glargine in patients inadequately controlled on insulin glargine (20-50 units) and metformin were studied in a 26 week trial.
Danish: Patienter, som skiftede fra insulin glargin (100 enheder/ml) til Xultophy eller intensivering af behandling med insulin glargin hos patienter, der ikke var tilstrækkeligt kontrolleret på insulin glargin (20-50 enheder) og metformin, blev undersøgt i et 26-ugers studie.
English: Table 3 Results at 26-weeks - Add on to oral glucose-lowering medicinal products
Danish: Tabel 3 Resultater efter 26 uger - supplement til orale antidiabetika
English: The maximum allowed dose was 50 dose steps for Xultophy and 50 units for insulin degludec.
Danish: Den maksimalt tilladte dosis var 50 dosistrin for Xultophy og 50 enheder for insulin degludec.
English: • Lower appetite, feeling or being sick (nausea or vomiting), diarrhoea, constipation, indigestion (dyspepsia), inflamed lining of the stomach (gastritis), stomach ache, heartburn or bloatingthese usually go away after a few days or weeks.
Danish: • Nedsat appetit, kvalme eller opkastning, diarré, forstoppelse, fordøjelsesproblemer (dyspepsi), betændt slimhinde i maven (gastritis), mavepine, halsbrand eller oppustethed - disse bivirkninger forsvinder normalt efter nogle få dage eller uger.
English: The overall exposure of liraglutide was equivalent following administration of Xultophy versus liraglutide alone while Cmax was lower by 23%.
Danish: Den samlede eksponering for liraglutid var ækvivalent efter administration af Xultophy som ved liraglutid alene, mens Cmax var 23% lavere.
English: Non-clinical safety data revealed no safety concern for humans based on repeated dose toxicity studies.
Danish: Prækliniske sikkerhedsdata viste ingen speciel sikkerhedsrisiko for mennesker vurderet ud fra studier af toksicitet efter gentagne doser.
English: • The other ingredients are glycerol, phenol, zinc acetate, hydrochloric acid and sodium hydroxide (for pH adjustment), and water for injections.
Danish: • Øvrige indholdsstoffer: Glycerol, phenol, zinkacetat, saltsyre og natriumhydroxid (til pHjustering), og vand til injektionsvæsker.
English: Animal studies with liraglutide have shown reproductive toxicity, see section 5.3.
Danish: Dyreforsøg med liraglutid har påvist reproduktionstoksicitet, se pkt.
English: Do not use Xultophy if you are breast-feeding.
Danish: Brug ikke Xultophy, hvis du ammer.
English: The pre-filled pen is designed to be used with NovoTwist or NovoFine injection needles up to a length of 8 mm and as thin as 32G.
Danish: Den fyldte pen er beregnet til anvendelse sammen med NovoTwist eller NovoFine engangsnåle med en længde på op til 8 mm og så tynde som 32G.
English: Store in a refrigerator (2°C to 8°C).
Danish: Opbevares i køleskab (2°C til 8°C).
English: Your dose of Xultophy is administered as ‘dose steps'.
Danish: Din dosis af Xultophy indgives som "dosistrin".
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING MULTIPACK LABEL
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE MULTIPAKNING ETIKET
English: Hypoglycaemia may develop if a patient is dosed with more Xultophy than required:
Danish: Hypoglykæmi kan forekomme, hvis en patient får en større dosis Xultophy end nødvendigt:
English: The rate of nocturnal hypoglycaemic events was similar with Xultophy and insulin degludec treatment.
Danish: Andelen af natlige hypoglykæmiske hændelser var den samme ved behandling med Xultophy og insulin degludec.
English: Treatment with Xultophy compared to a basal-bolus insulin regimen consisting of basal insulin (insulin glargine 100 units/mL) in combination with bolus insulin (insulin aspart) studied in a 26-week trial in patients with type 2 diabetes mellitus inadequately controlled on insulin glargine and metformin demonstrated a similar reduction of HbA1c in the two groups (mean value from 8.2% to 6.7% in both groups).
Danish: Behandling med Xultophy sammenlignet med et basal-bolusinsulin regime bestående af basalinsulin (insulin glargin 100 enheder/ml) i kombination med bolusinsulin (insulin aspart) blev undersøgt i et 26-ugers studie hos patienter med type 2 diabetes mellitus utilstrækkeligt kontrolleret på insulin glargin og metformin og viste en tilsvarende reduktion i HbA1c i de to grupper (gennemsnitsværdi fra 8,2% til 6,7% i begge grupper).
English: • Put the pen cap on your pen after each use to protect the solution from light.
Danish: • Sæt penhætten på pennen efter brug for at beskytte opløsningen mod lys.
English: Add-on to oral glucose-lowering medicinal products Adding Xultophy to metformin alone or in combination with pioglitazone in a 26-week randomised, controlled, open-label trial resulted in 60.4% of patients treated with Xultophy reaching a target of HbA1c <7% without confirmed hypoglycaemic episodes after 26 weeks of treatment.
Danish: I et 26 uges randomiseret, kontrolleret, åbent studie, hvor Xultophy blev anvendt som supplement til metformin alene eller i kombination med pioglitazon, medførte dette at 60,4% af de patienter, der blev behandlet med Xultophy, nåede et mål på HbA1c <7% uden bekræftede hypoglykæmiske episoder efter 26 ugers behandling.
English: Tabulated list of adverse reactions Adverse reactions associated with Xultophy are given below, listed by system organ class and frequency.
Danish: De bivirkninger, der er forbundet med Xultophy, er anført nedenfor efter systemorganklasse og hyppighed.
English: • To see precisely how much solution is left, use the dose counter:
Danish: • Brug dosistælleren til at se, præcis hvor meget opløsning, der er tilbage:
English: This may prevent blocked needles, contamination, infection, leakage of solution and inaccurate dosing.
Danish: Dette kan forhindre tilstopning af nålene, urenheder, infektion, udsivning af opløsning og upræcis dosering.
English: This may prevent blocked needles, contamination, infection and inaccurate dosing.
Danish: Derved kan tilstopning af nålene, urenheder, infektion og upræcis dosering undgås.
English: • low blood sugar (hypoglycaemia) - if your blood sugar is low, follow the advice in section 4 ‘Low blood sugar (hypoglycaemia)'.
Danish: • Lavt blodsukker (hypoglykæmi) - hvis dit blodsukker er lavt, skal du følge rådene under punkt 4 "Lavt blodsukker (hypoglykæmi)".
English: Compared to baseline, Xultophy resulted in an unchanged mean body weight compared to a mean weight increase of 2.0 kg for patients treated with insulin glargine (estimated treatment difference -1.92 kg [95% CI: -2.64; -1.19]).
Danish: Sammenlignet med baseline resulterede behandling med Xultophy i en uændret gennemsnitlig kropsvægt, hvorimod der sås en gennemsnitlig stigning i kropsvægt på 2,0 kg hos patienter behandlet med insulin glargin (estimeret behandlingsforskel på -1,92 kg [95% CI: -2,64; -1,19]).
English: Patients (%) achieving HbA1c <7% All patients
Danish: Patienter (%), der når HbA1c <7% Alle patienter
English: PARTICULARS TO APPEAR ON THE INNER PACKAGING CARTON FOR MULTIPACK
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE KARTON TIL MULTIPAKNING
English: Estimated difference, insulin degludec dose
Danish: Estimeret forskel, insulin degludec-dosis
English: The MAH shall provide educational materials prior to launch targeting all physicians and nurses who are expected to be involved in the treatment and management of diabetic patients and all pharmacists who are expected to dispense Xultophy.
Danish: Indehaveren af markedsføringstilladelsen skal ved lancering sikre, at læger og sygeplejersker, som forventes at være involverede i behandling af personer med diabetes, og alle farmaceuter, som forventes at udlevere Xultophy, er blevet forsynet med en undervisningspakke.
English: • Unscrew the needle and dispose of it carefully as instructed by your doctor or nurse.
Danish: • Skru nålen af, og bortskaf den sikkert, som lægen eller sygeplejersken har fortalt dig.
English: In a second trial, the transfer from basal insulin to Xultophy or insulin degludec was investigated in a 26-week randomised, double-blind trial in patients inadequately controlled on basal insulin (20-40 units) and metformin alone or in combination with sulfonylurea/glinides.
Danish: I et andet studie blev overførslen fra basalinsulin til Xultophy eller insulin degludec undersøgt i et 26ugers randomiseret, dobbeltblindet studie med patienter, der ikke var tilstrækkeligt kontrolleret på basalinsulin (20-40 enheder) og metformin alene eller i kombination med sulfonylurinstof/glinider.
English: • high blood sugar (hyperglycaemia) - if your blood sugar is high, follow the advice in section 4 ‘High blood sugar (hyperglycaemia)'.
Danish: • Højt blodsukker (hyperglykæmi) - hvis dit blodsukker er højt, skal du følge rådene under punkt 4 "Højt blodsukker (hyperglykæmi)".
English: Therefore, no dose adjustment of atorvastatin is required when given with liraglutide.
Danish: Dosisjustering af atorvastatin er derfor ikke nødvendig ved administration sammen med liraglutid.
English: Non-clinical data reveal no safety concern for humans based on studies of safety pharmacology, repeated dose toxicity, carcinogenic potential, and toxicity to reproduction.
Danish: Prækliniske data viser ingen speciel sikkerhedsrisiko for mennesker vurderet ud fra studier af sikkerhedsfarmakologi, toksicitet efter gentagne doser, karcinogenicitet samt reproduktionstoksicitet.
English: Transfer from GLP-1 receptor agonist Xultophy
Danish: Skift fra GLP-1 receptoragonister Xultophy
English: No studies have been performed with Xultophy in children and adolescents below 18 years of age.
Danish: Pædiatrisk population Der er ikke udført studier med Xultophy hos børn og unge under 18 år.
English: The percentage of patients experiencing severe or blood-glucose confirmed symptomatic hypoglycaemia was 19.8% in the Xultophy group and 52.6% in the basal-bolus insulin group, and the estimated rate ratio was 0.11 [95% CI: 0.08-0.17].
Danish: Andelen af patienter, som oplevede alvorlig eller blodglucose-bekræftet symptomatisk hypoglykæmi var 19,8% i gruppen behandlet med Xultophy og 52,6% i gruppen behandlet med basal-bolusinsulin, og den anslåede rate ratio var 0,11 [95% CI: 0,08-0,17].
English: Antidiabetic medicinal products, monoamine oxidase inhibitors (MAOI), beta-blockers, angiotensin converting enzyme (ACE) inhibitors, salicylates, anabolic steroids and sulfonamides.
Danish: Antidiabetika, monoaminoxidasehæmmere (MAO-hæmmere), betablokkere, ACE-hæmmere, salicylater, anabolske steroider og sulfonamider.
English: The curves are mean hypo rates from a negative binomial model with unique treatment trajectories and the symbols are observed hypo rates vs. mean HbA1c by quartiles.
Danish: hypoglykæmirater fra en negativ binomial model med unikke behandlingsbaner, og symbolerne viser observerede hypoglykæmirater versus gns.
English: Non-clinical data reveal no special hazards for human based on conventional studies of safety pharmacology, repeat-dose toxicity, or genotoxicity.
Danish: Prækliniske data viser ingen risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, toksicitet efter gentagne doser eller genotoksicitet.
English: Your blood sugar level may rise if you take:
Danish: Dit blodsukkerniveau kan stige, hvis du tager:
English: The following substances may increase the Xultophy requirement: Oral contraceptives, thiazides, glucocorticoids, thyroid hormones, sympathomimetics, growth hormones and danazol.
Danish: Orale kontraceptiva, thiazider, glukokortikoider, thyreoideahormoner, sympatomimetika, væksthormoner og danazol.
English: Uncommon (may affect up to 1 in 100 people)
Danish: Ikke almindelige bivirkninger (kan forekomme hos færre end 1 ud af 100 behandlede)
English: It delivers doses from: - 1 dose step - to a maximum of 50 dose steps (50 units insulin degludec + 1.8 mg liraglutide)
Danish: Den leverer doser fra: - 1 dosistrin - til maksimalt 50 dosistrin (50 enheder insulin degludec + 1,8 mg liraglutid).
English: Liraglutide exposure was lowered by 33%, 14%, 27% and 26%, in patients with mild (creatinine clearance, CrCl 50-80 mL/min), moderate (CrCl 30-50 mL/min), and severe (CrCl <30 mL/min) renal impairment and in end-stage renal disease requiring dialysis, respectively.
Danish: 26% hos patienter med henholdsvis let (kreatinin-clearance, CrCl 50-80 ml/min), moderat (CrCl 3050 ml/min) og alvorlig (CrCl <30 ml/min) nedsat nyrefunktion samt dialysekrævende terminal nyreinsufficiens.
English: • Belching (eructation) and wind (flatulence).
Danish: • Bøvsen (opstød), tarmluft (flatulens).
English: A Endpoints with confirmed superiority of Xultophy vs comparator
Danish: A Endepunkter med bekræftet superioritet for Xultophy versus komparator B p<0,0001
English: Antibody formation
Danish: Dannelse af antistoffer
English: A drop of solution may appear at the needle tip.
Danish: En dråbe opløsning kan komme til syne på nålens spids.
English: Digoxin median time to maximum concentration (tmax) was delayed from 1 h to 1.5 h. No dose adjustment of digoxin is required based on these results.
Danish: Digoxins mediantid til maksimumkoncentration (tmax) blev forsinket fra 1 time til 1,5 time.
English: Xultophy must not be drawn from the cartridge of the pre-filled pen into a syringe (see section 4.4).
Danish: Xultophy må ikke udtages fra cylinderampullen tilhørende den fyldte pen og ind i en sprøjte (se punkt
English: • Measure your blood sugar if possible and rest. You may need to measure your blood sugar more than once.
Danish: Det kan være nødvendigt at måle dit blodsukker mere end én gang.
English: Conversely, during hypoglycaemia liraglutide diminishes insulin secretion and does not impair glucagon secretion.
Danish: Omvendt mindsker liraglutid insulinsekretionen under hypoglykæmi uden at hæmme glucagonsekretionen.
English: • Check the name and coloured label of your pen, to make sure that it contains Xultophy.
Danish: 1 Klargør pennen med en ny nål • Kontrollér navnet og den farvede etiket på pennen for at sikre dig, at den indeholder Xultophy.
English: Before first opening: Store in a refrigerator (2°C - 8°C).
Danish: Før ibrugtagning: Opbevares i køleskab (2°C - 8°C).
English: Transfer from basal insulin
Danish: Skift fra basalinsulin
English: Thus, when blood glucose is high, insulin secretion is stimulated and glucagon secretion is inhibited.
Danish: Når glucoseniveauet i blodet er højt, stimuleres insulinsekretionen således, mens glucagonsekretionen hæmmes.
English: Examples dose steps selected dose steps selected
Danish: Eksempler dosistrin valgt dosistrin valgt
English: IDegLira=Xultophy, IGlar=insulin glargine
Danish: IDegLira=Xultophy, IGlar=insulin glargin
English: Nausea, diarrhoea, vomiting, constipation, dyspepsia, gastritis, abdominal pain, gastroesophageal reflux disease, abdominal distension
Danish: Almindelig Kvalme, diarré, opkastning, konstipation, dyspepsi, gastritis, abdominalsmerter, gastroøsophageal reflukssygdom, abdominal distension Ikke almindelig Ructus, flatulens Ikke kendt
English: Low blood sugar may happen if you:
Danish: Lavt blodsukker kan forekomme, hvis du:
English: A drop of solution should appear at the needle tip.
Danish: En dråbe opløsning skal komme til syne på nålens spids.
English: Populations not studied
Danish: Ikke-undersøgte patientgrupper
English: • Insulin secretion/beta-cell function Xultophy improves beta-cell function compared to insulin degludec as measured by the homeostasis model assessment for beta-cell function (HOMA-β).
Danish: Xultophy forbedrer betacellefunktionen sammenlignet med insulin degludec målt via HOMA-β-index (homeostasemodelvurdering for betacellefunktion).
English: There is no difference in the pharmacokinetics of insulin degludec between healthy subjects and patients with renal impairment.
Danish: Der er ingen forskel i de farmakokinetiske egenskaber af insulin degludec mellem raske forsøgspersoner og patienter med nedsat leverfunktion.
English: GLP-1 receptor agonist
Danish: GLP-1 receptoragonister
English: Solution for injection Multipack: 10 (2 packs of 5) 3 mL pre-filled pens
Danish: Injektionsvæske, opløsning Multipakning: 10 (2 pakninger med 5) fyldte penne à 3 ml
English: Neonatal growth was reduced in rats while exposed to liraglutide, and persisted in the post-weaning period in the high dose group.
Danish: Den neonatale vækst blev reduceret hos rotter, der blev eksponeret for liraglutid.
English: The recommended starting dose of Xultophy is 10 dose steps (10 units insulin degludec and 0.36 mg liraglutide).
Danish: Den anbefalede startdosis af Xultophy er 10 dosistrin (10 enheder insulin degludec og 0,36 mg liraglutid).
English: Glycerol, phenol, zinc acetate, hydrochloric acid and sodium hydroxide (for pH adjustment), and water for injections
Danish: Glycerol, phenol, zinkacetat, saltsyre og natriumhydroxid (til pH-justering), og vand til injektionsvæsker
English: Headache, slurred speech, fast heartbeat, cold sweat, cool pale skin, feeling sick (nausea), feeling very hungry, shaking, feeling nervous or worried, unusually tired, weak and sleepy or confused, difficulty concentrating, short-lasting changes in your sight.
Danish: Hovedpine, sløret tale, hurtig hjertebanken, koldsved, kold og bleg hud, kvalme, usædvanlig stor sultfornemmelse, rysten, nervøsitet eller bekymring, unormal træthed, svaghed og døsighed eller forvirring, koncentrationsbesvær, kortvarige synsforstyrrelser.
English: Your blood sugar level may fall if you take:
Danish: Dit blodsukkerniveau kan falde, hvis du tager:
English: Dosing time
Danish: Doseringstidspunkt
English: Transfer from basal insulin therapies
Danish: Skift fra behandling med basalinsulin
English: How to inject
Danish: Sådan skal du injicere
English: Figure 1 Mean HbA1c (%) by treatment week (left) and rate of confirmed hypoglycaemia per patient year of exposure vs mean HbA1c (%) (right) in patients with type 2 diabetes mellitus inadequately controlled on metformin alone or in combination with pioglitazone
Danish: Figur 1 Gennemsnitlig HbA1c (%) efter behandlingsuge (til venstre) og raten af bekræftet hypoglykæmi pr. patienteksponeringsår versus gennemsnitlig HbA1c (%) (til højre) hos patienter med type 2-diabetes mellitus, der var utilstrækkeligt kontrolleret på metformin alene eller i kombination med pioglitazon
English: A reduction in HbA1c from baseline to month 36 was observed with liraglutide vs placebo, in addition to standard of care (-1.16% vs -0.77%; estimated treatment difference [ETD] -0.40% [-0.45; -0.34]).
Danish: En reduktion i HbA1c fra baseline til måned 36 blev observeret med liraglutid versus placebo givet som supplement til standardbehandlingen (-1,16% versus -0,77%; estimeret behandlingsforskel [ETD]
English: High blood sugar may happen if you:
Danish: Højt blodsukker kan forekomme, hvis du:
English: The rate per patient year of exposure (percentage of patients) of severe hypoglycaemia was 0.02 (2 patients out of 288) for Xultophy and 0.00 (0 patients out of 146) for placebo.
Danish: Raten pr. patienteksponeringsår (procentdel af patienter) for alvorlig hypoglykæmi var 0,02 (2 patienter ud af 288) for Xultophy og 0,00 (0 patienter ud af 146) for placebo.
English: Other medicines and Xultophy
Danish: Brug af anden medicin sammen med Xultophy
English: • Injection site reactions.
Danish: • Reaktioner på injektionsstedet.
English: Add on to metformin ± pioglitazone
Danish: Supplement til metformin ± pioglitazon
English: Keep the cap on the pre-filled pen in order to protect from light.
Danish: Opbevar den fyldte pen med hætten påsat for at beskytte mod lys.
English: If pancreatitis is suspected, Xultophy should be discontinued; if acute pancreatitis is confirmed, Xultophy should not be restarted.
Danish: Hvis akut pankreatitis bliver bekræftet, må behandling med Xultophy ikke genoptages.
English: Therapy with basal insulin should be discontinued prior to initiation of Xultophy.
Danish: Behandling med basalinsulin skal seponeres, inden Xultophy initieres.
English: • Change the place within the area where you inject each day to reduce the risk of developing lumps and skin pitting (see section 4).
Danish: Hermed reducerer du risikoen for at udvikle knuder og fordybninger i huden (se punkt 4).
English: Each unused pre-filled pen (3 mL) contains 300 units of insulin degludec and 10.8 mg liraglutide.
Danish: Hver ubrugt fyldt pen (3 ml) indeholder 300 enheder insulin degludec og 10,8 mg liraglutid.