FrancophonIA/ELRC3.0 huggingface dataset:
English: Simulations of steady-state plasma concentrations of linagliptin with and without ritonavir indicated that the increase in exposure will be not associated with an increased accumulation.
Danish: Simulationer af steady state-plasmakoncentrationer af linagliptin med og uden samtidig administration af ritonavir antydede, at den øgede eksponering ikke er forbundet med øget akkumulering.
English: At high concentrations, where DPP-4 is fully saturated, 70-80 % of linagliptin was bound to other plasma proteins than DPP-4, hence 30-20 % were unbound in plasma.
Danish: Ved høje koncentrationer, hvor DPP-4 er fuldt mættet, var 70-80 % af linagliptin bundet til andre plasmaproteiner end DPP-4, og 30-20 % var ubundet i plasma.
English: Hypoglycaemia (when used with sulphonylurea or insulin) Thirst
Danish: Hypoglykæmi (ved anvendelse sammen med sulfonylurinstof eller insulin) Tørst
English: Co-administration with other potent inducers of P-gp and CYP3A4, such as carbamazepine, phenobarbital and phenytoin, has not been studied.
Danish: Samtidig administration af andre potente P-gp- og CYP3A4-induktorer, såsom carbamazepin, phenobarbital og phenytoin er ikke undersøgt.
English: No clinically relevant effect of Cmax and Tmax changes is expected; therefore linagliptin may be administered with or without food.
Danish: Der forventes ingen klinisk relevante virkninger af ændringerne i Cmax og Tmax, og linagliptin kan derfor indtages med eller uden mad.
English: In vitro assessment of empagliflozin
Danish: In vitro-vurdering af empagliflozin
English: One patient administered Glyxambi experienced a confirmed (investigator-defined), major hypoglycaemic event (defined as an event requiring assistance) in the active- or placebo-controlled trials (overall frequency 0,1 %).
Danish: En patient, der fik Glyxambi, oplevede en bekræftet (investigator-defineret) alvorlig hypoglykæmisk hændelse (defineret som en behandlingskrævende hændelse) i de aktivt- eller placebo-kontrollerede studier (samlet hyppighed 0,1 %).
English: • inflamed nose or throat (nasopharyngitis)
Danish: • betændelse i næse eller svælg (nasofaryngit)
English: The genital tract infections were mild and moderate in intensity, none was severe in intensity.
Danish: De genitale infektioner var af let eller moderat sværhedsgrad, og ingen var alvorlige.
English: • passing more urine than usual or needing to pass urine more often
Danish: • større urinmængde eller hyppigere trang til at lade vandet
English: Contact a doctor or the nearest hospital straight away as these symptoms could be a sign of “diabetic ketoacidosis” - a problem you can get with diabetes because of increased levels of “ketone bodies” in your urine or blood, seen in tests.
Danish: Kontakt straks en læge eller det nærmeste hospital, da disse symptomer kan være tegn på diabetisk ketoacidose - en komplikation, du kan få ved diabetes som følge af forhøjet indhold af ketonstoffer i urinen eller blodet, målt ved laboratorieanalyser.
English: Therefore, Glyxambi is not recommended for use in this population.
Danish: Derfor anbefales Glyxambi ikke til denne population.
English: A double dose should not be taken to compensate for a forgotten dose.
Danish: Patienten må ikke tage en dobbeltdosis for at kompensere for en glemt dosis.
English: - 95.0 % CI - p-value Last observation (prior to glycaemic rescue ) carried forward (LOCF) Mean adjusted for baseline value and stratification
Danish: 95,0 % CI p-værdi Sidste observation (før glykæmisk nødbehandling) ekstrapoleret (LOCF) Middelværdi justeret for baseline-værdi og stratificering
English: If Fournier´s gangrene is suspected, Glyxambi should be discontinued and prompt treatment (including antibiotics and surgical debridement) should be instituted.
Danish: Hvis der er mistanke om Fourniers gangræn, bør Glyxambi seponeres, og øjeblikkelig behandling (herunder antibiotika og kirurgisk debridement) bør iværksættes.
English: Non clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, genotoxicity, fertility and early embryonic development.
Danish: Prækliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, genotoksicitet, fertilitet og tidlig fosterudvikling.
English: Loss of body fluid (dehydration), seen uncommonly The signs of dehydration are not specific, but may include:
Danish: Væsketab (dehydrering) - en ikke almindelig bivirkning Tegnene på dehydrering er ikke specifikke, men kan omfatte:
English: Pharmacotherapeutic group: Drugs used in diabetes, combinations of oral blood glucose lowering drugs, ATC code: A10BD19
Danish: Farmakoterapeutisk klassifikation: Antidiabetika, kombinationer af orale blodglucosesænkende midler, ATC-kode: A10BD19
English: Adverse effects on renal development were not observed after administration of empagliflozin alone, linagliptin alone or after administration of the combined products.
Danish: Der blev ikke observeret negative virkninger på nyreudviklingen efter administration af empagliflozin alene, linagliptin alene eller efter administration af stofferne i kombination.
English: Other side effects while taking Glyxambi:
Danish: Andre bivirkninger, mens du tager Glyxambi:
English: The observed effect of food on empagliflozin pharmacokinetics was not considered clinically relevant and empagliflozin may be administered with or without food.
Danish: Den observerede indvirkning af mad på empagliflozins farmakokinetik blev ikke betragtet som værende klinisk relevant, og empagliflozin kan administreres med eller uden mad.
English: There are no data about the hypoglycaemic risk of Glyxambi when used with insulin and/or sulphonylurea.
Danish: Der foreligger ingen data for den hypoglykæmiske risiko ved Glyxambi, når det anvendes sammen med insulin og/eller sulfonylurinstof.
English: The safety profile of Glyxambi did not differ in the elderly.
Danish: Sikkerhedsprofilen for Glyxambi afveg ikke hos ældre patienter.
English: The reduction of cardiovascular death was comparable for empagliflozin 10 mg and 25 mg and confirmed by an improved overall survival (see Table 5).
Danish: Reduktionen i kardiovaskulær død var omtrent den samme for empagliflozin 10 mg og 25 mg og blev bekræftet af en bedre samlet overlevelse (Se tabel 5).
English: No dosage adjustment is necessary for Glyxambi based on body mass index.
Danish: Dosisjustering af Glyxambi er ikke nødvendig på grundlag af Body Mass Index (BMI).
English: In patients with type 2 diabetes, urinary glucose excretion increased immediately following the first dose of empagliflozin and was continuous over the 24-hour dosing interval.
Danish: Hos patienter med type 2-diabetes mellitus blev udskillelsen af glucose i urinen øget øjeblikkeligt efter første dosis empagliflozin og var kontinuerlig over det 24 timer lange doseringsinterval.
English: C]-empagliflozin solution to healthy volunteers, approximately 96 % of the drug-related radioactivity was eliminated in faeces (41 %) or urine (54 %).
Danish: C]-empagliflozinopløsning til raske frivillige blev ca. 96 % af den lægemiddelrelaterede radioaktivitet udskilt i fæces (41 %) eller urin (54 %).
English: No additional adverse reactions were identified with Glyxambi.
Danish: Ingen yderligere bivirkninger blev identificeret med Glyxambi.
English: OATP2, OATP8, OCTN1, OCT1 and OATP2 activities were slightly to weakly inhibited by linagliptin.
Danish: OATP2-, OATP8-, OCTN1-, OCT1- og OATP2-aktiviteter blev svagt til let hæmmet af linagliptin.
English: Film coating Hypromellose 2910 Mannitol (E421) Talc
Danish: Filmovertræk Hypromellose 2910 Mannitol (E421) Talcum
English: The most serious adverse reactions were ketoacidosis (< 0.1%), pancreatitis (0.2%), hypersensitivity (0.6%), and hypoglycaemia (2.4%) (see section 4.4).
Danish: De alvorligste bivirkninger var ketoacidose (< 0,1 %), pankreatitis (0,2 %), overfølsomhed (0,6 %) og hypoglykæmi (2,4 %) (se pkt.
English: • necrotising fasciitis of the perineum or Fournier´s gangrene, a serious soft tissue infection of the genitals or the area between the genitals and the anus
Danish: • nekrotiserende fasciitis i mellemkødet (Fourniers gangræn), en alvorlig bløddelsinfektion i kønsdelene eller området mellem kønsdelene og anus
English: Linagliptin is a weak competitive and a weak to moderate mechanism-based inhibitor of CYP isozyme CYP3A4, but does not inhibit other CYP isozymes.
Danish: Linagliptin er en svag kompetitiv hæmmer og en svag til moderat mekanisme-baseret hæmmer af CYP3A4, men hæmmer ikke andre CYP-isozymer.
English: Plasma concentrations of linagliptin decline in a triphasic manner with a long terminal half-life (terminal half-life for linagliptin more than 100 hours) that is mostly related to the saturable, tight binding of linagliptin to DPP-4 and does not contribute to the accumulation of the medicinal product.
Danish: Plasmakoncentrationen af linagliptin aftager på en tre-faset måde med en lang terminal halveringstid (længere end 100 timer), der overvejende er relateret til linagliptins saturable, tætte binding til DPP-4 og ikke bidrager til akkumulering af lægemidlet.
English: Linagliptin cardiovascular safety (CAROLINA) study
Danish: Linagliptin kardiovaskulær sikkerhed (CAROLINA)-studie
English: The mechanism of action of empagliflozin is independent of beta cell function and insulin pathway and this contributes to a low risk of hypoglycaemia.
Danish: Empagliflozins virkningsmekanisme er uafhængig af beta-cellefunktion og insulinsystemet, og dette er medvirkende til den lave risiko for hypoglykæmi.
English: Contact your doctor if you experience any of the following during treatment with Glyxambi:
Danish: Kontakt lægen, hvis du får en eller flere af følgende bivirkninger under behandling med Glyxambi:
English: • Linagliptin works in a different way, namely by enabling the pancreas to produce more insulin to lower blood glucose levels.
Danish: • Linagliptin virker på en anden måde, nemlig ved at aktivere bugspytkirtlen til at producere mere insulin og derved sænke blodsukkeret.
English: Talk to your doctor if you have kidney problems.
Danish: Tal med lægen, hvis du har problemer med nyrerne.
English: C] linagliptin oral 10 mg dose, approximately 5 % of the radioactivity was excreted in urine.
Danish: C]-linagliptindosis på 10 mg blev ca. 5 % af radioaktiviteten udskilt med urinen.
English: Linagliptin had no adverse effects on fertility or early embryonic development at exposures greater than 900-times the clinical exposure.
Danish: Linagliptin havde ingen utilsigtede virkninger på fertilitet eller tidlig fosterudvikling ved eksponeringer, der var højere end 900 gange den kliniske eksponering.
English: Empagliflozin does not inhibit other glucose transporters important for glucose transport into peripheral tissues and is 5,000 times more selective for SGLT2 versus SGLT1, the major transporter responsible for glucose absorption in the gut.
Danish: Empagliflozin hæmmer ikke andre glucosetransportproteiner, der er vigtige for transport af glucose ind i perifere væv, og er 5.000 gange mere selektiv for SGLT2 end for SGLT1, det vigtigste transportprotein med ansvar for absorption af glucose i tarmen.
English: A minor fraction is metabolised via uridine 5'diphosphoglucuronosyltransferases (UGT); therefore, a clinically relevant effect of UGT inhibitors on empagliflozin is not expected (see section 5.2).
Danish: En mindre del metaboliseres via uridin-5difosfatglukuronosyltransferaser (UGT); en klinisk relevant effekt af UGT-hæmmere på empagliflozin forventes derfor ikke (se pkt.
English: Elderly subjects (65 to 80 years) had comparable plasma concentrations of linagliptin compared to younger subjects.
Danish: Ældre patienter (65 til 80 år) og yngre havde sammenlignelige plasmakoncentrationer af linagliptin.
English: In clinical trials, nineteen patients 75 years or older were treated with Glyxambi.
Danish: I kliniske studier blev 19 patienter i alderen 75 år og derover behandlet med Glyxambi.
English: This helps to lower blood glucose levels, which are too high because of your type 2 diabetes.
Danish: Dette hjælper med til at sænke blodsukkeret, der generelt er for højt hos type 2-diabetikere.
English: The adverse reactions shown in the table below (see Table 1) are listed by system organ class and are based on the safety profiles of empagliflozin and linagliptin monotherapy.
Danish: Bivirkningerne i tabellen herunder (se tabel 1) er anført efter systemorganklasse og er baseret på sikkerhedsprofilerne for empagliflozin- og linagliptin-monoterapi.
English: • other anti-diabetic medicines, such as insulin or a sulphonylurea.
Danish: • Anden antidiabetika, f.eks. insulin eller et sulfonylurinstof.
English: CV = cardiovascular, MI = myocardial infarction Treated set (TS), i.e. patients who had received at least one dose of study drug Pooled doses of empagliflozin 10 mg and 25 mg Since data from the trial were included in an interim analysis, a two-sided 95.02% confidence interval applied which corresponds to a p-value of less than 0.0498 for significance.
Danish: CV = kardiovaskulær, MI = myokardieinfarkt Behandlet sæt, dvs. patienter, der har fået mindst én dosis forsøgslægemiddel Puljede doser af empagliflozin 10 mg og 25 mg Da data fra studiet indgår i en interim-analyse, er der anvendt et to-sidet 95,02 %-konfidensinterval, hvilket svarer til p < 0,0498 for signifikans.
English: Your doctor may want to reduce your dose of these medicines when you take them together with Glyxambi, in order to avoid too low blood sugar (hypoglycaemia).
Danish: Lægen vil måske nedsætte dosis af disse lægemidler, når du tager dem sammen med Glyxambi for at undgå, at blodsukkeret bliver for lavt (hypoglykæmi).
English: Limited data from clinical trials suggest that DKA occurs with common frequency when patients with type 1 diabetes are treated with SGLT2 inhibitors.
Danish: Begrænsede data fra kliniske studier tyder på, at DKA optræder med hyppigheden almindelig, når patienter med type 1-diabetes behandles med SGLT2-hæmmere.
English: Not evaluated for statistical significance; not part of sequential testing procedure for the secondary endpoints Logistic regression on FAS (NCF) includes baseline HbA1c, baseline eGFR (MDRD), geographical region, and treatment; based on patients with HbA1c of 7 % and above at baseline
Danish: Ikke vurderet for statistisk signifikans; ikke del af sekventiel testprocedure for de sekundære endepunkter Logistisk regression på FAS (NCF) omfatter baseline-HbA1c, baseline-eGFR (MDRD), geografisk område og behandling - på grundlag af patienter med HbA1c på 7 % og derover ved baseline
English: • increased blood enzyme amylase
Danish: • øget indhold af enzymet amylase i blodet
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS BLISTER (perforated)
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER BLISTER (perforerede)
English: • You can take Glyxambi with or without food.
Danish: • Glyxambi kan tages med eller uden mad.
English: Your doctor may prescribe Glyxambi together with another anti-diabetic medicine.
Danish: Lægen kan ordinere Glyxambi sammen med andre antidiabetika.
English: In pooled clinical trials of Glyxambi in patients with type 2 diabetes and inadequate glycaemic control on background metformin, the frequency of the reported hypoglycaemic events was 2.4 %.
Danish: I de samlede kliniske studier med Glyxambi hos patienter med type 2-diabetes og utilstrækkelig glykæmisk kontrol med metformin som baggrundsbehandling var hyppigheden af rapporterede hypoglykæmiske hændelser 2,4 %.
English: During controlled clinical trials in healthy subjects, single doses of up to 600 mg linagliptin (equivalent to 120 times the recommended dose) were generally well tolerated.
Danish: I kontrollerede kliniske studier med raske frivillige var enkeltdoser på op til 600 mg linagliptin (svarende til 120 gange den anbefalede dosis) generelt veltolererede.
English: Glyxambi should not be used for the treatment of diabetic ketoacidosis.
Danish: Glyxambi bør ikke anvendes til behandling af diabetisk ketoacidose.
English: Most toxicity was consistent with secondary pharmacology related to urinary glucose loss and electrolyte imbalances including decreased body weight and body fat, increased food consumption, diarrhoea, dehydration, decreased serum glucose and increases in other serum parameters reflective of increased protein metabolism and gluconeogenesis, urinary changes such as polyuria and glucosuria, and microscopic changes including mineralisation in kidney and some soft and vascular tissues.
Danish: Toksiciteten stemte for det meste overens med sekundære farmakologiske virkninger med relation til tab af glucose via urin og elektrolytforstyrrelser, herunder nedsat kropsvægt og kropsfedt, øget fødeindtagelse, diarré, dehydrering, nedsat serumglucose og stigninger i andre serumparametre, der afspejler øget proteinmetabolisme og gluconeogenese, urinforandringer som for eksempel polyuri og glukosuri og mikroskopiske forandringer, herunder mineralisering i nyrerne og visse bløddele og vaskulære væv.
English: No drug interaction studies have been performed with Glyxambi and other medicinal products; however, such studies have been conducted with the individual active substances.
Danish: Der er ikke udført interaktionsstudier med Glyxambi og andre lægemidler; sådanne studier er dog blevet udført med de to aktive stoffer.
English: Hypoglycaemias in the placebo-controlled studies (10.9 %; N=471) were mild (80 %; N=384), moderate (16.6 %; N=78) or severe (1.9 %; N=9) in intensity.
Danish: Tilfældene af hypoglykæmi i de placebo-kontrollerede studier (10,9 %; N= 471) var lette (80 %; N= 384), moderate (16,6 %; N= 78) eller svære (1,9 %; N= 9) i intensitet.
English: Overall, the safety profile of Glyxambi was in line with the safety profiles of the individual active substances (empagliflozin and linagliptin).
Danish: Overordnet var sikkerhedsprofilen for Glyxambi på linje med sikkerhedsprofilerne for de to aktive stoffer (empagliflozin og linagliptin).
English: Glyxambi can therefore be taken with or without food.
Danish: Glyxambi kan derfor tages med eller uden mad.
English: The risk of DKA must be considered in the event of non-specific symptoms such as nausea, vomiting, anorexia, abdominal pain, excessive thirst, difficulty breathing, confusion, unusual fatigue or sleepiness.
Danish: Muligheden for DKA skal overvejes ved ikke-specifikke symptomer såsom kvalme, opkastning, anoreksi, abdominalsmerter, udtalt tørst, vejrtrækningsbesvær, konfusion, usædvanlig træthed eller søvnighed.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE PAKNING
English: Restarting SGLT2 inhibitor treatment in patients with previous DKA while on SGLT2 inhibitor treatment is not recommended, unless another clear precipitating factor is identified and resolved.
Danish: Genoptagelse af behandling med en SGLT2-hæmmer anbefales ikke hos patienter, der tidligere har haft DKA under behandling med en SGLT2-hæmmer, medmindre en anden tydelig medvirkende faktor identificeres og afhjælpes.
English: In analyses for albuminuria progression (change from normoalbuminuria to micro-or macroalbuminuria, or from microalbuminuria to macroalbuminuria) the estimated hazard ratio was 0.86 (95 % CI 0.78, 0.95) for linagliptin versus placebo.
Danish: I analyser for progression af albuminuri (ændring fra normoalbuminuri til mikro- eller makroalbuminuri, eller fra mikroalbuminuri til makroalbuminuri) var den estimerede hazard ratio 0,86 (95 % CI 0,78; 0,95) for linagliptin versus placebo.
English: Based on results of pharmacokinetic studies, no dose adjustment of Glyxambi is recommended when co-administered with commonly prescribed medicinal products, except those mentioned below.
Danish: På grundlag af resultater fra farmakokinetiske studier er dosisjustering af Glyxambi ikke nødvendig, når det administreres sammen med almindeligt ordinerede lægemidler - med undtagelse af dem, der nævnes herunder.
English: Based on in vitro studies, empagliflozin does not inhibit, inactivate, or induce CYP450 isoforms.
Danish: På grundlag af in vitro studier hverken hæmmer, inaktiverer eller inducerer empagliflozin CYP-isoformer.
English: Therapeutic experience is limited with Glyxambi in patients > 75 years of age, and, no experience is available in patients aged 85 years and older.
Danish: Den terapeutiske erfaring med Glyxambi hos patienter over 75 år er begrænset, og der er ingen erfaring hos patienter på 85 år og derover.
English: It is not known whether the active substances of Glyxambi pass into human breast milk.
Danish: Det vides ikke, om de aktive stoffer i Glyxambi går over i mælken hos mennesker.
English: Linagliptin was a substrate for OATP8-, OCT2-, OAT4-, OCTN1- and OCTN2, suggesting a possible OATP8-mediated hepatic uptake, OCT2-mediated renal uptake and OAT4-, OCTN1- and OCTN2mediated renal secretion and reabsorption of linagliptin in vivo.
Danish: Linagliptin var substrat for OATP8, OCT2, OAT4, OCTN1 og OCTN2, hvilket antyder en mulig OATP8-medieret hepatisk optagelse, OCT2-medieret renal optagelse samt OAT4-, OCTN1- og OCTN2-medieret renal sekretion og reabsorption af linagliptin in vivo.
English: Empagliflozin is a substrate of the human uptake transporters OAT3, OATP1B1, and OATP1B3, but not Organic Anion Transporter 1 (OAT1) and Organic Cation Transporter 2 (OCT2).
Danish: Empagliflozin er substrat for de humane optagelsestransportere OAT3, OATP1B1 og OATP1B3, men ikke for organisk aniontransporter-1 (OAT1) og organisk kationtransporter-2 (OCT2).
English: Administration of empagliflozin 25 mg after intake of a high-fat and high calorie meal resulted in slightly lower exposure; AUC decreased by approximately 16 % and Cmax by approximately 37 % compared to fasted condition.
Danish: Administration af empagliflozin 25 mg efter indtagelse af et fedt- og kalorierigt måltid resulterede i en lidt lavere eksponering; AUC faldt med ca. 16 % og Cmax med ca. 37 % sammenlignet med faste.
English: If pancreatitis is suspected, Glyxambi should be discontinued; if acute pancreatitis is confirmed, Glyxambi should not be restarted.
Danish: Hvis der er mistanke om pankreatitis, skal Glyxambi seponeres; hvis akut pankreatitis bekræftes, må behandling med Glyxambi ikke påbegyndes igen.
English: In vitro assessment of linagliptin
Danish: In vitro-vurdering af linagliptin
English: Taking this medicine in combination with sulphonylureas or insulin, can cause your blood sugar levels to drop too low (hypoglycaemia), which may cause symptoms such as shaking, sweating and changes in vision, and may affect your ability to drive and use machines.
Danish: Hvis du tager dette lægemiddel i kombination med et sulfonylurinstof eller insulin, kan du få for lavt blodsukker (hypoglykæmi), som kan give symptomer som rysteture, svedtendens og synsforstyrrelser, og som kan påvirke din evne til at køre motorkøretøj og betjene maskiner.
English: Do not take Glyxambi: - if you are allergic to empagliflozin, linagliptin, any other SGLT2 inhibitor (e.g. dapagliflozin, canagliflozin), any other DPP-4 inhibitor (e.g. sitagliptin, vildagliptin), or any of the other ingredients of this medicine (listed in section 6).
Danish: Tag ikke Glyxambi: - hvis du er allergisk over for empagliflozin, linagliptin, en anden SGLT2-hæmmer (f.eks. dapagliflozin, canagliflozin), en anden DPP-4-hæmmer (f.eks. sitagliptin, vildagliptin) eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i afsnit 6).
English: Body Weight-24 weeks
Danish: Kropsvægt - 24 uger
English: Allergic reactions, seen uncommonly (may affect up to 1 in 100 people) This medicine may cause allergic reactions, which may be serious, including hives (urticaria) and swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing (angioedema).
Danish: Allergiske reaktioner - en ikke almindelig bivirkning (kan forekomme hos op til 1 ud af 100 brugere) Dette lægemiddel kan give allergiske reaktioner, som kan være alvorlige, herunder nældefeber (urticaria) samt hævelse af ansigt, læber, tunge og svælg, hvilket kan give problemer med at trække vejret eller synke (angioødem).