FrancophonIA/ELRC3.0 huggingface dataset:
English: Temporary interruption of treatment with Glyxambi should be considered until the fluid loss is corrected.
Danish: Midlertidig afbrydelse af behandlingen med Glyxambi, indtil væsketabet er korrigeret, skal overvejes.
English: Initiation of therapy with Glyxambi in this population is not recommended (see section 4.2).
Danish: Initiering af behandling med Glyxambi hos denne population anbefales ikke (se pkt.
English: Linagliptin cardiovascular and renal safety (CARMELINA) study
Danish: Linagliptin studie af kardiovaskulær og renal sikkerhed (CARMELINA)
English: The mode of action for these tumours is dependent on the natural predisposition of the male mouse to renal pathology and a metabolic pathway not reflective of humans.
Danish: Disse tumorers virkningsmekanisme afhænger af hanmusens naturlige disponering for nyrepatologi og en metabolisk signalvej, der ikke afspejler forholdene hos mennesker.
English: Your doctor may limit your dose or decide to use an alternative medicine.
Danish: Lægen kan nedsætte dosis eller beslutte at bruge et andet lægemiddel.
English: Plasma protein binding of linagliptin is concentration-dependent, decreasing from about 99 % at 1 nmol/L to 75-89 % at ≥30 nmol/L, reflecting saturation of binding to DPP-4 with increasing concentration of linagliptin.
Danish: Linagliptins plasmaproteinbinding er koncentrationsafhængig og falder fra ca. 99 % ved 1 nmol/l til 75-89 % ved ≥ 30 nmol/l, hvilket afspejler, at bindingen til DPP-4 bliver mættet ved stigende linagliptinkoncentration.
English: GLP-1 and GIP increase insulin biosynthesis and secretion from pancreatic beta cells in the presence of normal and elevated blood glucose levels.
Danish: GLP-1 og GIP øger biosyntesen af insulin og sekretionen af insulin fra bugspytkirtlens betaceller ved normale og forhøjede blodglucosekoncentrationer.
English: There was no notable difference of the incidence in patients treated with different dose strengths of Glyxambi compared to the treatment with empagliflozin or linagliptin.
Danish: Der var ingen særlig forskel i forekomst hos patienter behandlet med forskellige styrker af Glyxambi sammenlignet med behandling med empagliflozin eller linagliptin.
English: The study population included 1211 (17.4 %) patients ≥ 75 years of age, the mean HbA1c was 8.0 %, 63 % were male.
Danish: Studiepopulationen omfattede 1211 (17,4 %) patienter ≥ 75 år, gennemsnitlig HbA1c var 8,0 %, 63 % var mænd.
English: Other medicines and Glyxambi Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
Danish: Brug af anden medicin sammen med Glyxambi Fortæl det altid til lægen eller apotekspersonalet, hvis du tager anden medicin eller har gjort det for nylig.
English: Empagliflozin may add to the diuretic effect of thiazide and loop diuretics and may increase the risk of dehydration and hypotension (see section 4.4).
Danish: Empagliflozin kan potensere den diuretiske virkning af thiazid- og loop-diuretika og øge risikoen for dehydrering og hypotension (se pkt.
English: At exposures greater than 1,500-times the clinical exposure, side effects on reproductive organs, thyroid and the lymphoid organs were seen in rats.
Danish: Ved eksponeringer på mere end 1.500 gange den kliniske eksponering blev der observeret negative virkninger på reproduktive organer, thyroidea og lymfoide organer hos rotter.
English: This results in high levels of sugar in your blood, which can lead to medical problems like heart disease, kidney disease, blindness, and poor circulation in your limbs.
Danish: Det medfører et for højt sukkerindhold i blodet, som kan give helbredsproblemer som hjertesygdom, nyresygdom, blindhed og dårligt blodomløb i dine arme og ben.
English: The risk of developing diabetic ketoacidosis may be increased with prolonged fasting, excessive alcohol consumption, dehydration or sudden reductions in insulin dose, or following major surgery or serious illness that increases your need for insulin.
Danish: Risikoen for at udvikle diabetisk ketoacidose kan være øget ved længerevarende faste, stort alkoholforbrug, væskemangel (dehydrering) eller pludselig nedsættelse af insulindosis samt efter et større kirurgisk indgreb eller alvorlig sygdom, der øger dit behov for insulin.
English: At exposures sufficiently in excess of exposure in humans after therapeutic doses, empagliflozin had no adverse effects on fertility or early embryonic development.
Danish: Ved eksponeringer, der i tilstrækkelig grad oversteg eksponeringen hos mennesker ved terapeutiske doser, havde empagliflozin ingen utilsigtede virkninger på fertilitet eller tidlig fosterudvikling.
English: At exposures sufficiently in excess of exposure in humans after therapeutic doses, the combination of empagliflozin and linagliptin was not teratogenic and did not show maternal toxicity.
Danish: Ved eksponeringer, der i tilstrækkelig grad oversteg eksponeringen hos mennesker ved terapeutiske doser, var kombinationen af empagliflozin og linagliptin ikke teratogen og viste ingen tegn på maternel toksicitet.
English: • if you are taking other anti-diabetic medicines known as “sulphonylurea” (e.g. glimepiride, glipizide) and/or insulin.
Danish: • hvis du tager lægemidler mod diabetes, der kaldes sulfonylurinstoffer (f.eks. glimepirid, glipizid) og/eller insulin.
English: The unbound concentrations, which are usually less than 1 % at the therapeutic dose of linagliptin, were increased 4 to 5-fold after co-administration with ritonavir.
Danish: Koncentrationen af ubundet linagliptin, som normalt er mindre end 1 % ved terapeutisk dosis, blev forøget 4-5 gange efter samtidig administration af ritonavir.
English: Co-administration of a high-fat meal with linagliptin prolonged the time to reach Cmax by 2 hours and lowered Cmax by 15 % but no influence on AUC0-72h was observed.
Danish: Indtagelse af linagliptin i forbindelse med et måltid med højt fedtindhold forlængede tiden til Cmax med 2 timer og reducerede Cmax med 15 %, men der blev ikke observeret nogen indvirkning på AUC0-72t.
English: • increased pancreas enzyme lipase
Danish: • øget indhold af bugspytkirtel-enzymet lipase
English: No such effect was seen at systemic exposure 49-times the maximal clinical exposure to linagliptin.
Danish: En sådan virkning blev ikke observeret ved en systemisk eksponering på 49 gange den maksimale kliniske eksponering for linagliptin.
English: • blistering of skin (bullous pemphigoid)
Danish: • blæredannelse på huden (bulløs pemfigoid)
English: Co-administration of a single 5 mg oral dose of linagliptin and multiple 200 mg oral doses of ritonavir, a potent inhibitor of P-glycoprotein and CYP3A4, increased the AUC and Cmax of linagliptin approximately twofold and threefold, respectively.
Danish: Samtidig administration af en enkelt oral dosis på 5 mg linagliptin og multiple orale doser på 200 mg ritonavir, en potent hæmmer af P-glykoprotein og CYP3A4, gav en stigning på cirka to og tre gange i henholdsvis AUC og Cmax for linagliptin.
English: Glyxambi can also be used as an alternative to taking both empagliflozin and linagliptin as single tablets.
Danish: Glyxambi kan også bruges som et alternativ til at tage både empagliflozin-tabletter og linagliptintabletter.
English: However, caution is advised when Glyxambi is used in combination with antidiabetics.
Danish: Der bør dog udvises forsigtighed, når Glyxambi anvendes i kombination med antidiabetika.
English: This medicine is not recommended for children and adolescents under 18 years, because it has not been studied in these patients.
Danish: Børn og unge Glyxambi anbefales ikke til børn og unge under 18 år, da det ikke er undersøgt hos disse patienter.
English: No dose adjustment is required in patients with mild to moderate hepatic impairment.
Danish: Dosisjustering er ikke nødvendig hos patienter med let til moderat nedsat leverfunktion.
English: If you already take 25 mg empagliflozin and 5 mg linagliptin as separate tablets and you switch to Glyxambi, you can start directly with Glyxambi 25 mg/5 mg.
Danish: Hvis du allerede tager 25 mg empagliflozin og 5 mg linagliptin som separate tabletter, og du skifter til Glyxambi, kan du starte direkte med Glyxambi 25 mg/5 mg.
English: Therefore, clinically relevant interactions would not be expected with other P-glycoprotein / CYP3A4 inhibitors.
Danish: Der forventes derfor ikke klinisk relevante interaktioner med andre P-gp-/CYP3A4-hæmmere.
English: Linagliptin is a P-glycoprotein substrate, and inhibits P-glycoprotein mediated transport of digoxin with low potency.
Danish: Linagliptin er substrat for P-glykoprotein og hæmmer P-gp-medieret transport af digoxin med lav potens.
English: Glyxambi has minor influence on the ability to drive and use machines.
Danish: Glyxambi påvirker i mindre grad evnen til at føre motorkøretøj og betjene maskiner.
English: Linagliptin is an inhibitor of the enzyme DPP-4 an enzyme which is involved in the inactivation of the incretin hormones GLP-1 and GIP (glucagon-like peptide¬1, glucose-dependent insulinotropic polypeptide).
Danish: Linagliptin hæmmer enzymet DPP-4, et enzym, der er involveret i inaktiveringen af inkretinhormonerne GLP-1 (glucagonlignende peptid-1) og GIP (glucoseafhængigt insulinotropt polypeptid).
English: As a result of tissue binding, the mean apparent volume of distribution at steady-state following a single 5 mg intravenous dose of linagliptin to healthy subjects is approximately 1,110 litres, indicating that linagliptin extensively distributes to the tissues.
Danish: På grund af vævsbinding var det gennemsnitlige tilsyneladende fordelingsvolumen ved steady state efter en enkelt intravenøs dosis på 5 mg linagliptin hos raske frivillige ca. 1.110 liter, hvilket antyder, at linagliptin har en udtalt vævsfordeling.
English: Baseline (mean) in kg Change from baseline (adjusted mean)
Danish: Baseline (middelværdi) i kg Ændring fra baseline (justeret middelværdi)
English: Focal areas of hepatocellular necrosis were found in the combination groups at ≥15: 30 mg/kg linagliptin: empagliflozin (3.8 times the clinical exposure for linagliptin and 7.8 times the clinical exposure for empagliflozin) as well as in the group treated with empagliflozin alone but not in the control group.
Danish: Områder med fokal hepatocellulær nekrose blev fundet i kombinationsgrupperne ved ≥ 15: 30 mg/kg linagliptin: empagliflozin (3,8 gange den kliniske eksponering for linagliptin og 7,8 gange den kliniske eksponering for empagliflozin) samt i den gruppe, der blev behandlet med empagliflozin alene, men ikke i kontrolgruppen.
English: Patients should be advised to take precautions to avoid hypoglycaemia while driving and using machines, in particular when Glyxambi is used in combination with other antidiabetic medicinal products known to cause hypoglycaemia (e.g. insulin and analogues, sulphonylureas).
Danish: Patienterne skal rådes til at tage forholdsregler for at undgå hypoglykæmi, når de fører motorkøretøj og betjener maskiner, særligt når Glyxambi anvendes i kombination med antidiabetika, der er kendt for at forårsage hypoglykæmi (f.eks. insulin og analoger, sulfonylurinstoffer).
English: Empagliflozin does not inhibit human uptake transporters such as OAT3, OATP1B1, and OATP1B3 in vitro at clinically relevant plasma concentrations and, as such, drug-drug interactions with substrates of these uptake transporters are considered unlikely.
Danish: Empagliflozin hæmmer ikke humane optagelsestransportproteiner som OAT3, OATP1B1 og OATP1B3 in vitro ved klinisk relevante plasmakoncentrationer, og lægemiddelinteraktioner med substrater for disse optagelsestransportproteiner anses for usandsynlige.
English: Patients who may be at higher risk of DKA include patients with a low beta-cell function reserve (e.g. type 2 diabetes patients with low C-peptide or latent autoimmune diabetes in adults (LADA) or patients with a history of pancreatitis), patients with conditions that lead to restricted food intake or severe dehydration, patients for whom insulin doses are reduced and patients with increased insulin requirements due to acute medical illness, surgery or alcohol abuse.
Danish: Der er forhøjet risiko for DKA hos patienter med lav restfunktion af betaceller (f.eks. patienter med type 2-diabetes og lavt C-peptid-niveau, voksne patienter med latent autoimmun diabetes (LADA) eller patienter med pankreatitis i anamnesen), patienter med tilstande, der medfører begrænset fødeindtagelse eller svær dehydrering, patienter, hvis insulindoser er reduceret, samt patienter med øget insulinbehov som følge af akutte medicinske sygdomme, kirurgi eller alkoholmisbrug.
English: The most frequently reported adverse event in clinical trials with linagliptin was hypoglycaemia observed under the triple combination, linagliptin plus metformin plus sulphonylurea (22.9 % vs 14.8 % in placebo).
Danish: Den hyppigst rapporterede bivirkning i kliniske studier med linagliptin var hypoglykæmi, observeret under trestof-kombinationen linagliptin plus metformin plus sulfonylurinstof (22,9 % mod 14,8 % for placebo).
English: Increased urinary glucose excretion resulted in an immediate reduction in plasma glucose levels in patients with type 2 diabetes.
Danish: Den øgede udskillelse af glucose i urinen medførte en øjeblikkelig nedsættelse af plasmaglucose hos patienter med type 2-diabetes.
English: In controlled clinical studies single doses of up to 800 mg empagliflozin (equivalent to 32 times the highest recommended daily dose) in healthy volunteers and multiple daily doses of up to 100 mg empagliflozin (equivalent to 4 times the highest recommended daily dose) in patients with type 2 diabetes did not show any toxicity.
Danish: I kontrollerede kliniske studier viste enkeltdoser på op til 800 mg empagliflozin (svarende til 32 gange den højeste anbefalede daglige dosis) hos raske frivillige og gentagen administration af daglige doser på op til 100 mg empagliflozin (svarende til 4 gange den højeste anbefalede daglige dosis) hos patienter med type 2-diabetes ingen toksiske virkninger.
English: Linagliptin administered during the period of organogenesis was not teratogenic.
Danish: Linagliptin administreret under organogenesen var ikke teratogent.
English: The population pharmacokinetic analysis showed that the apparent oral clearance of empagliflozin decreased with a decrease in eGFR leading to an increase in drug exposure (see section 4.2).
Danish: Den farmakokinetiske populationsanalyse viste, at et fald i eGFR reducerede den tilsyneladende orale clearance af empagliflozin, hvilket medførte øget lægemiddeleksponering (se pkt.
English: Empagliflozin in patients inadequately controlled on metformin and linagliptin
Danish: Empagliflozin hos patienter, der er utilstrækkeligt kontrolleret med metformin og linagliptin
English: Consistent with the half life, up to 22 % accumulation, with respect to plasma AUC, was observed at steady state.
Danish: I overensstemmelse med halveringstiden blev der ved steady state observeret op til 22 % akkumulering, bedømt ved plasma-AUC.
English: Pyelonephritis and urosepsis were not reported from the clinical trials in patients treated with Glyxambi.
Danish: Pyelonefritis og urosepsis blev ikke rapporteret hos patienter, der fik Glyxambi i de kliniske studier.
English: Your blood sugar levels may increase when you stop taking Glyxambi.
Danish: Blodsukkeret kan stige, hvis du holder op med at tage Glyxambi.
English: Non-clinical studies with empagliflozin and linagliptin as single agents do not indicate direct or indirect harmful effects with respect to fertility (see section 5.3).
Danish: Ikke-kliniske studier med empagliflozin og linagliptin som enkeltpræparater indikerer hverken direkte eller indirekte skadelige virkninger på fertiliteten (se pkt.
English: Glyxambi added to metformin
Danish: Glyxambi kombineret med metformin
English: Effects of other medicinal products on linagliptin
Danish: Andre lægemidlers indvirkning på linagliptin
English: Overall, the frequencies for Glyxambi have been comparable to those reported from the empagliflozin clinical trials.
Danish: Overordnet var hyppighederne for Glyxambi sammenlignelige med dem, der er rapporteret fra de kliniske studier med empagliflozin.
English: Linagliptin glucose-dependently increases insulin secretion and lowers glucagon secretion thus resulting in an overall improvement in the glucose homeostasis.
Danish: Afhængigt af glucoseniveauet øger linagliptin insulinsekretionen og nedsætter glucagonsekretionen, hvilket medfører en samlet forbedring i glucosehomøostasen.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Glyxambi in all subsets of the paediatric population in type 2 diabetes mellitus (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med Glyxambi i en eller flere undergrupper af den pædiatriske population ved type 2-diabetes mellitus (se pkt.
English: After oral administration of a 5 mg dose to healthy volunteers or patients, linagliptin was rapidly absorbed, with peak plasma concentrations (median Tmax) occurring 1.5 hours post-dose.
Danish: Efter oral administration af en 5 mg dosis til raske frivillige eller patienter blev linagliptin absorberet hurtigt, og maksimal plasmakoncentration (median Tmax) blev nået 1,5 time efter indtagelsen.
English: • if you experience rapid weight loss, feeling sick or being sick, stomach pain, excessive thirst, fast and deep breathing, confusion, unusual sleepiness or tiredness, a sweet smell to your breath, a sweet or metallic taste in your mouth, or a different odour to your urine or sweat.
Danish: • hvis du oplever hurtigt vægttab, kvalme eller opkastning, mavesmerter, udtalt tørst, hurtig og dyb vejrtrækning, forvirring, usædvanlig søvnighed eller træthed, din ånde lugter sødligt, en sød eller metallisk smag i munden eller en unormal lugt fra urin eller sved.
English: The study included patients with renal insufficiency classified on the basis of creatinine clearance as mild (50 to <80 mL/min), moderate (30 to <50 mL/min), and severe (<30 mL/min), as well as patients with ESRD on haemodialysis.
Danish: Studiet omfattede patienter med nedsat nyrefunktion, der ud fra kreatinin-clearance blev klassificeret som let (50 til < 80 ml/min), moderat (30 til < 50 ml/min) og svær (< 30 ml/min) samt patienter med terminal nyreinsufficiens i hæmodialyse.
English: Common Common Rare
Danish: Almindelig Almindelig Sjælden
English: Table 6 Major adverse cardiovascular events (MACE) and mortality by treatment group in the CAROLINA study
Danish: Tabel 6 Større kardiovaskulære bivirkninger (MACE) og mortalitet pr. behandlingsgruppe i CAROLINA-studiet Linagliptin 5 mg
English: Urinary tract infection, seen commonly The signs of urinary tract infection are:
Danish: Urinvejsinfektion - en almindelig bivirkning Tegnene på urinvejsinfektion er:
English: In addition, linagliptin did not increase the risk of hospitalization for heart failure [HR=0.90; (95 % CI 0.74, 1.08)].
Danish: Desuden øgede linagliptin ikke risikoen for indlæggelse for hjertesvigt [HR=0,90 (95 % CI 0,74; 1,08)].
English: After oral administration, empagliflozin was rapidly absorbed with peak plasma concentrations occurring at a median tmax of 1.5 hours post dose.
Danish: Efter oral administration absorberedes empagliflozin hurtigt, og peak-plasmakoncentrationen blev nået med en median tmax på 1,5 time efter dosering.
English: Liver, kidneys and gastrointestinal tract are the principal target organs of toxicity in mice and rats.
Danish: Lever, nyrer og mave-tarm-kanalen var de primære målorganer for toksisk påvirkning hos mus og rotter.
English: Effects of other medicinal products on empagliflozin
Danish: Andre lægemidlers indvirkning på empagliflozin
English: • Empagliflozin works by blocking a protein in the kidneys called sodium glucose co-transporter 2 (SGLT2).
Danish: • Empagliflozin virker ved at blokere proteinet natrium-glukose-co-transporter-2 (SGLT2).
English: Blood creatinine increased/Glomerular filtration rate decreased
Danish: Forhøjet serumkreatinin/nedsat glomerulær filtrationshastighed
English: Coadministration of digoxin, a P-gp substrate, with empagliflozin resulted in a 6 % increase in AUC and 14 % increase in Cmax of digoxin.
Danish: Samtidig administration af digoxin, et P-gp-substrat, og empagliflozin medførte en forøgelse i AUC på 6 % og en stigning i Cmax på 14 % for digoxin.
English: - 95.0 % CI - p-value vs. 25 mg vs. 10 mg
Danish: 95,0 % CI p-værdi med 25 mg med 10 mg
English: These conditions can cause dehydration.
Danish: Disse forhold kan medføre væskemangel.
English: Approximately 19 % of the population had an eGFR <60 mL/min/1.73 m
Danish: Ca. 19 % af populationen havde en eGFR på < 60 ml/min/1,73 m².
English: • if you are 75 years old or older, as increased passing of urine due to the medicine may affect fluid balance in your body and increase your risk of dehydration.For possible signs of dehydration, see section 4.
Danish: • hvis du er 75 år eller derover, da hyppigere vandladning på grund af medicinen kan påvirke væskebalancen i kroppen og øge risikoen for væskemangel.
English: Empagliflozin improves glycaemic control in patients with type 2 diabetes mellitus by reducing renal glucose re-absorption.
Danish: Empagliflozin forbedrer den glykæmiske kontrol hos patienter med type 2-diabetes mellitus ved at nedsætte den renale reabsorption af glucose.
English: Vaginal moniliasis, vulvovaginitis, balanitis and other genital infection
Danish: Vaginal moniliasis, vulvovaginitis, balanitis og andre genitale infektioner
English: At more than 100-times clinical exposure, irritation of the stomach was the major finding in monkeys.
Danish: Ved en eksponering på mere end 100 gange den kliniske eksponering var irritation af mavesækken det primære fund hos disse aber.
English: Linagliptin binds selectively to DPP-4 and exhibits a > 10,000-fold selectivity versus DPP-8 or DPP-9 activity in vitro.
Danish: In vitro binder linagliptin selektivt til DPP-4 og udviser en > 10.000 gange større selektivitet for dette enzym end for DPP-8 og DPP-9.
English: These infections were reported more frequently for empagliflozin compared to placebo in female patients, and the difference in frequency was less pronounced in male patients.
Danish: Infektionerne blev rapporteret hyppigere for empagliflozinbehandlede kvinder, sammenlignet med placebo, og forskellen i hyppighed var mindre udtalt hos mænd.
English: If bullous pemphigoid is suspected, Glyxambi should be discontinued.
Danish: Hvis der er mistanke om bulløs pemfigoid, skal Glyxambi seponeres.
English: Available non-clinical data in animals have shown excretion of empagliflozin and linagliptin in milk.
Danish: Tilgængelige ikke-kliniske data fra dyrestudier viser, at empagliflozin og linagliptin udskilles i mælk.
English: Liver, kidneys, stomach, reproductive organs, thymus, spleen, and lymph nodes were target organs of toxicity in Cynomolgus monkeys at more than 450-times the clinical exposure.
Danish: reproduktionsorganer, thymus, milt og lymfeknuder var målorganer for toksicitet hos cynomolgusaber ved mere end 450 gange den kliniske eksponering.
English: Inflammation of the pancreas (pancreatitis), seen uncommonly This medicine may cause pancreatitis, which usually shows as persistent, severe abdominal (stomach) pain that might reach through to your back, often accompanied by feeling sick or being sick.
Danish: Betændelse i bugspytkirtlen (pankreatitis) - en ikke almindelig bivirkning Dette lægemiddel kan give pankreatitis, der normalt viser sig som vedvarende, svære mavesmerter, der kan strække sig bagud til ryggen, og ofte er ledsaget af kvalme og opkastning.
English: Your doctor may want to lower the dose of these other medicines, to prevent your blood sugar levels from getting too low.
Danish: Din læge kan beslutte at nedsætte din dosis af disse lægemidler for at forhindre for lavt blodsukker.