FrancophonIA/ELRC3.0 huggingface dataset:
English: 1, Blood creatinine increased/Glomerular filtration rate decreased
Danish: 1, forhøjet indhold af kreatinin i blodet/nedsat glomerulær filtrationsrate
English: The risk of diabetic ketoacidosis 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: Risikoen for diabetisk ketoacidose skal overvejes ved ikke-specifikke symptomer som f.eks. kvalme, opkastning, anoreksi, abdominalsmerter, udtalt tørst, vejrtrækningsbesvær, forvirring, usædvanlig træthed eller søvnighed.
English: Avoid excessive alcohol intake while taking Segluromet since this may increase the risk of lactic acidosis (see section “Warnings and precautions”).
Danish: Du skal undgå at indtage store mængder alkohol, mens du er i behandling med Segluromet, da det kan øge risikoen for laktacidose (se punktet ”Advarsler og forsigtighedsregler”).
English: In in vitro studies, ertugliflozin and ertugliflozin glucuronides did not inhibit or inactivate CYPs 1A2, 2C9, 2C19, 2C8, 2B6, 2D6, or 3A4, and did not induce CYPs 1A2, 2B6, or 3A4.
Danish: I in vitro-studier hverken hæmmede eller inaktiverede ertugliflozin og ertugliflozin-glukuronider CYP-isoenzymerne 1A2, 2C9, 2C19, 2C8, 2B6, 2D6 eller 3A4 og inducerede ikke CYP 1A2, 2B6 eller 3A4.
English: Based on results from animal studies, ertugliflozin may affect renal development and maturation (see section 5.3).
Danish: Baseret på resultater fra dyrestudier kan ertugliflozin påvirke udviklingen og modningen af nyrerne (se pkt.
English: Necrotising fasciitis of the perineum (Fournier's gangrene) Post-marketing cases of necrotising fasciitis of the perineum, (also known as Fournier's gangrene), have been reported in female and male patients taking SGLT2 inhibitors.
Danish: Nekrotiserende fasciitis i perineum (Fourniers gangræn) Der er efter markedsføring rapporteret om tilfælde af nekrotiserende fasciitis i perineum (også kendt som Fourniers gangræn) hos kvindelige og mandlige patienter, der behandles med SGLT2-hæmmere.
English: Serum lipids changed
Danish: Ændrede serumlipider
English: It is important to check your feet regularly and adhere to any other advice regarding foot care and adequate hydration given by your healthcare professional.
Danish: Det er vigtigt, at du regelmæssigt kontrollerer dine fødder og overholder de retningslinjer for fodpleje og passende væskeindtagelse, som du får af lægen eller sygeplejersken.
English: Before initiating Segluromet, factors in the patient history that may predispose to ketoacidosis should be considered.
Danish: Inden initiering af behandlingen med Segluromet skal der tages højde for faktorer i patientens anamnese, der kan prædisponere for ketoacidose.
English: Metformin did not adversely affect developmental outcomes when administered to rats and rabbits at doses up to 600 mg/kg/day.
Danish: Metformin påvirkede ikke de udviklingsmæssige resultater negativt ved administration af doser op til 600 mg/kg/dag til rotter og kaniner.
English: Pool of placebo-controlled trials
Danish: Poolet analyse af placekontrollerede studier
English: Alcohol intoxication is associated with an increased risk of lactic acidosis, particularly in cases of fasting, malnutrition or hepatic impairment.
Danish: Alkoholforgiftning er forbundet med en øget risiko for laktacidose, især i tilfælde af faste, fejlernæring eller nedsat leverfunktion.
English: • Swallow the tablet; if you have difficulties in swallowing the tablet can be broken or crushed.
Danish: • Synk tabletten; tabletten kan deles eller knuses, hvis du har synkebesvær.
English: • redness of the skin
Danish: • rødme i huden
English: Segluromet should be discontinued when GFR is persistently below 45 ml/min due to a reduction of efficacy.
Danish: Segluromet skal seponeres, hvis GFR vedvarende ligger under 45 ml/min som følge af nedsat virkning.
English: In rare instances, phimosis was reported and sometimes circumcision was performed (see section 4.4).
Danish: Der blev i sjældne tilfælde rapporteret om phimosis, og der blev i visse tilfælde foretaget omskæring (se pkt.
English: When ertugliflozin was used as monotherapy, the incidence of hypoglycaemic events in the ertugliflozin groups was 2.6% in both groups and 0.7% in the placebo group.
Danish: Når ertugliflozin blev anvendt som monoterapi, var incidensen af hypoglykæmiske hændelser i ertugliflozin-grupperne 2,6% i begge grupper og 0,7% i placebogruppen.
English: Across the clinical program for ertugliflozin, ketoacidosis was identified in 3 of 3,409 (0.1%) ertugliflozin-treated patients and 0.0% of comparator-treated patients (see section 4.4).
Danish: I det kliniske program for ertugliflozin blev der identificeret ketoacidose hos 3 ud af 3.409 (0,1%) ertugliflozin-behandlede patienter og 0,0% hos patienterne i komparatorgruppen (se pkt.
English: Overall, ertugliflozin is unlikely to affect the pharmacokinetics of concurrently administered medications that are substrates of these transporters.
Danish: Generelt er det ikke sandsynligt, at ertugliflozin vil påvirke farmakokinetikken for samtidigt administrerede lægemidler, der er substrater for disse transportører.
English: • have had a lower limb amputation.
Danish: • har fået foretaget amputation af en underekstremitet.
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: Patienter, der kan have en højere risiko for diabetisk ketoacidose, omfatter patienter med lav restfunktion af betaceller (f.eks. patienter med type 2-diabetes med lavt C-peptid eller latent autoimmun diabetes hos voksne eller patienter med pankreatitis i anamnesen), patienter med tilstande der medfører lav fødeindtagelse eller svær dehydrering, patienter, hvis insulindosis er blevet nedsat, og patienter med øget insulinbehov på grund af akut sygdom, kirurgi eller alkoholmisbrug.
English: Because renal function abnormalities can occur after initiating ertugliflozin, and metformin is known to be substantially excreted by the kidneys, Segluromet should be used with caution in the elderly.
Danish: Da der kan forekomme unormal nyrefunktion efter initiering af behandling med ertugliflozin, og da metformin vides hovedsageligt at blive udskilt via nyrerne, skal Segluromet anvendes med forsigtighed hos ældre patienter.
English: Metformin decreases hepatic glucose production, decreases intestinal absorption of glucose, and improves insulin sensitivity by increasing peripheral glucose uptake and utilisation.
Danish: Metformin nedsætter leverens produktion af glucose, nedsætter glucoseoptagelsen i tarmene og forbedrer insulinfølsomheden ved at øge den perifere glucoseoptagelse og -udnyttelse.
English: Similarly, in controlled clinical studies in patients with type 2 diabetes, the antihyperglycaemic effect of metformin was comparable in males and females.
Danish: I kontrollerede kliniske studier med patienter med type 2-diabetes var metformins antihyperglykæmiske virkning ligeledes sammenlignelig hos mænd og kvinder.
English: The AUC of ertugliflozin decreased by approximately 13%, and Cmax decreased by approximately 21% compared to subjects with normal hepatic function.
Danish: AUC for ertugliflozin faldt med ca. 13%, og Cmax faldt med ca. 21% sammenlignet med forsøgspersoner med normal leverfunktion.
English: If you forget to take Segluromet
Danish: Hvis du har glemt at tage Segluromet
English: In the event of an overdose with Segluromet, employ the usual supportive measures (e.g., remove unabsorbed material from the gastrointestinal tract, employ clinical monitoring, and institute supportive treatment) as dictated by the patient's clinical status.
Danish: Ved overdosering med Segluromet skal de sædvanlige understøttende foranstaltninger iværksættes (f.eks. fjerne uabsorberet materiale fra mave-tarm-kanalen, anvende klinisk monitorering og igangsætte understøttende behandling) afhængigt af patientens kliniske status.
English: If you stop taking Segluromet
Danish: Hvis du holder op med at tage Segluromet
English: Patients received ertugliflozin 5 mg (N=519), ertugliflozin 15 mg (N=510), or placebo (N=515) once daily.
Danish: Patienterne fik ertugliflozin 5 mg (N=519), ertugliflozin 15 mg (N=510) eller placebo (N=515) en gang dagligt.
English: At a maternally toxic dose in rats (250 mg/kg/day), lower foetal viability and a higher incidence of a visceral malformation were observed at maternal exposure that was 510 times the maximum clinical dose of 15 mg/day.
Danish: Ved en maternelt toksisk dosis hos rotter (250 mg/kg/dag) sås lavere føtal levedygtighed og en højere incidens af visceral misdannelse ved maternel eksponering, der var 510 gange den maksimale kliniske dosis på 15 mg/dag.
English: These increases in ertugliflozin AUC are not considered clinically relevant.
Danish: Disse stigninger i AUC for ertugliflozin anses ikke for klinisk relevante.
English: • Inducers of OCT1 (such as rifampicin) may increase gastrointestinal absorption and efficacy of metformin.
Danish: • Induktorer af OCT1 (såsom rifampicin) kan øge gastrointestinal absorption og metformins virkning.
English: Therapy may be restarted no earlier than 48 hours following surgery or resumption of oral nutrition and provided that renal function has been re-evaluated and found to be stable.
Danish: Behandling må tidligst genoptages 48 timer efter operationen eller genoptagelse af oral ernæring og under forudsætning af, at nyrefunktionen er blevet revurderet og fundet stabil.
English: Effects on bone (shorter femur length, increased trabecular bone in the femur) as well as effects of delayed puberty were observed at an exposure 817 times the MHRD of 15 mg/day based on AUC.
Danish: Indvirkning på knoglerne (kortere lårbenslængde, længere trabekulær lårbensknogle) samt indvirkning i form af forsinket pubertet blev observeret ved en eksponering på 817 gange MRHD på 15 mg/dag baseret på AUC.
English: Includes: pollakiuria, micturition urgency, polyuria, urine output increased, and nocturia.
Danish: Omfatter: pollakisuri, imperiøs vandladningstrang, polyuri, øget urinproduktion og nykturi.
English: • if you have a severe infection or are dehydrated.
Danish: • hvis du har en alvorlig infektion eller har væskemangel.
English: (For study results with respect to combinations and effects on glycaemic control, see sections 4.4, 4.5 and 5.1.)
Danish: (For studieresultater vedrørende kombinationer og effekt på glykæmisk kontrol, se pkt.
English: Intravascular administration of iodinated contrast agents may lead to contrast-induced nephropathy, resulting in metformin accumulation and an increased risk of lactic acidosis.
Danish: Intravaskulær administration af iodholdige kontrastmidler kan medføre kontrastinduceret nefropati, resulterende i akkumulation af metformin og øget risiko for laktacidose.
English: Infections and infestations Very common
Danish: Infektioner og parasitære sygdomme Meget almindelig
English: Following single-dose oral administration of 5 mg and 15 mg of ertugliflozin, peak plasma concentrations (median Tmax) of ertugliflozin occur at 1 hour post-dose under fasted conditions.
Danish: Efter oral administration af enkeltdosis på 5 mg og 15 mg ertugliflozin opnås maksimale plasmakoncentrationer (median Tmax) af ertugliflozin 1 time efter dosering under fastende forhold.
English: Monitor for signs and symptoms after initiating therapy.
Danish: Patienten skal monitoreres for tegn og symptomer efter initiering af behandling.
English: Metformin is contraindicated in patients with GFR < 30 ml/min and should be temporarily discontinued in the presence of conditions that alter renal function (see section 4.3).
Danish: Metformin er kontraindiceret hos patienter med GFR < 30 ml/min, og behandlingen skal afbrydes midlertidigt ved tilstedeværelse af tilstande, der påvirker nyrefunktionen (se pkt.
English: Overall, ertugliflozin is unlikely to affect the pharmacokinetics of concurrently administered drugs eliminated by these enzymes.
Danish: Generelt er det ikke sandsynligt, at ertugliflozin vil påvirke farmakokinetikken for samtidigt administrerede lægemidler, der elimineres af disse enzymer.
English: Packs of 30x1 film-coated tablets in perforated unit dose blisters.
Danish: Pakning med 30 x 1 filmovertrukne tabletter i perforerede enkeltdosisblistre.
English: If you notice any of the side effects above, contact a doctor or the nearest hospital straight away.
Danish: Hvis du bemærker en eller flere af ovenstående bivirkninger, skal du straks kontakte en læge eller det nærmeste hospital.
English: Povidone K29-32 (E1201) Microcrystalline cellulose (E460) Crospovidone (E1202) Sodium lauryl sulfate (E487) Magnesium stearate (E470b)
Danish: Povidon K29-32 (E1201) Mikrokrystallinsk cellulose (E460) Crospovidon (E1202) Natriumlaurilsulfat (E487) Magnesiumstearat (E470b)
English: Vulvovaginal mycotic infection and other female genital mycotic infections*
Danish: Vulvovaginal svampeinfektion og andre svampeinfektioner i de kvindelige kønsorganer*
English: Sexual maturation was delayed in both sexes at 250 mg/kg/day (estimated 620 times the MRHD at 15 mg/day, based on AUC).
Danish: Seksuel modning var forsinket hos begge køn ved 250 mg/kg/dag (anslået til at være 620 gange MRHD ved 15 mg/dag, baseret på AUC).
English: In an ongoing clinical study of ertugliflozin added to existing therapy in type 2 diabetes patients with a history of established cardiovascular disease, an approximately 1.2-1.6-fold increase in cases of lower limb amputation (primarily of the toe) has been observed in patients treated with ertugliflozin.
Danish: I et igangværende klinisk studie med ertugliflozin som tillæg til eksisterende behandling hos patienter med type 2-diabetes med fastslået kardiovaskulær sygdom i anamnesen er der observeret en stigning på cirka 1,2-1,6 gange i antallet af amputationer af underekstremiteter (primært en tå) hos patienter, der fik ertugliflozin.
English: Ertugliflozin caused effects in the offspring of lactating rats.
Danish: Ertugliflozin medførte virkninger hos diegivende rotters afkom.
English: Across the four studies, the racial distribution ranged from 66.2% to 80.3% White, 10.6% to 20.3% Asian, 1.9% to 10.3% Black, and 4.5% to 7.4% other.
Danish: I de 4 studier var racefordelingen 66,2 - 80,3% kaukasere, 10,6 - 20,3 % asiater, 1,9 - 10,3% negroide og 4,5 - 7,4% af anden race.
English: Metformin is an antihyperglycaemic agent which improves glucose tolerance in patients with type 2 diabetes, lowering both basal and post-prandial plasma glucose.
Danish: Metformin er et antihyperglykæmisk stof, som forbedrer glucosetolerancen hos patienter med type 2diabetes, og som sænker både basal og postprandial plasmaglucose.
English: Unlike sulphonylureas, metformin does not produce hypoglycaemia in either patients with type 2 diabetes or normal subjects, except in special circumstances (see section 4.5), and does not cause hyperinsulinaemia.
Danish: Til forskel fra sulfonylurinstoffer fremkalder metformin ikke hypoglykæmi hos hverken patienter med type 2diabetes eller normale forsøgspersoner, bortset fra særlige omstændigheder (se pkt.
English: Volume depletion (ertugliflozin)
Danish: Volumendepletering (ertugliflozin)
English: Ertugliflozin-related neoplastic findings included an increased incidence of benign adrenal medullary pheochromocytoma in male rats at 15 mg/kg/day.
Danish: Ertugliflozin-relaterede neoplastiske fund omfattede en øget incidens af godartede adrenale medullære fæokromocytomer hos hanrotter ved 15 mg/kg/dag.
English: • blood tests may show changes in the amount of urea in your blood
Danish: • blodprøver kan vise ændringer i mængden af urinstof i blodet
English: The apparent volume of distribution (V/F) of metformin following single oral doses of metformin hydrochloride tablets 850 mg averaged 654 ± 358 l. Metformin is negligibly bound to plasma proteins.
Danish: Det tilsyneladende fordelingsvolumen (V/F) af metformin efter orale enkeltdoser af tabletter med 850 mg metforminhydrochlorid lå i gennemsnit på 654 ± 358 l. Metformin binder sig kun minimalt til plasmaproteiner.
English: • 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, contact a doctor or the nearest hospital straight away.
Danish: • oplever hurtigt vægttab, kvalme eller opkastning, mavesmerter, ekstrem tørst, hurtig og dyb vejrtrækning, forvirring, usædvanlig søvnighed eller træthed, sødlig ånde, sødlig eller metallisk smag i munden, eller at din urin eller sved lugter anderledes.
English: The 24-hour urinary glucose excretion declined with increasing severity of renal impairment (see section 4.4).
Danish: Udskillelsen af glucose i urin over 24 timer faldt i takt med stigende sværhedsgrad af nedsat nyrefunktion (se pkt.
English: Signs of toxicity that were considered adverse were generally observed at exposures greater than or equal to 77 times the human unbound exposure (AUC) at the maximum recommended human dose (MRHD) of 15 mg/day.
Danish: Tegn på toksicitet, der blev anset for at være uønsket, blev generelt observeret ved eksponeringer højere end eller lig med 77 gange den humane ubundne eksponering (AUC) ved maksimal anbefalet human dosis (MRHD) på 15 mg/dag.
English: The risk of developing diabetic ketoacidosis may be increased with prolonged fasting, excessive alcohol consumption, dehydration, sudden reductions in insulin dose, or a higher need of insulin due to major surgery or serious illness.
Danish: Risiko for at udvikle diabetisk ketoacidose kan øges ved langvarig faste, meget stort alkoholforbrug, dehydrering, pludselige nedsættelser af insulindosis eller et større behov for insulin på grund af større operation eller alvorlig sygdom.
English: Fertility of male or female rats was unaffected by metformin when administered at doses as high as 600 mg/kg/day, which is approximately three times the maximum recommended human daily dose based on body surface area comparisons.
Danish: Fertiliteten hos han- og hunrotter var upåvirket af metformin ved administration af doser helt op til 600 mg/kg/dag, hvilket er ca. tre gange den maksimale anbefalede humane daglige dosis baseret på sammenligninger af legemsoverflade.
English: Pharmacologically mediated effects were observed in juvenile rats treated with ertugliflozin (see section 5.3).
Danish: Farmakologisk medierede effekter blev observeret hos unge rotter, der fik ertugliflozin (se pkt.
English: Effects of ertugliflozin on the pharmacokinetics of other medicinal products Interaction studies conducted in healthy volunteers suggest that ertugliflozin had no clinically relevant effect on the pharmacokinetics of sitagliptin, metformin, and glimepiride.
Danish: Ertugliflozins indvirkning på andre lægemidlers farmakokinetik Interaktionsstudier udført med raske frivillige forsøgspersoner tyder på, at ertugliflozin ikke havde klinisk relevant indvirkning på farmakokinetikken for sitagliptin, metformin og glimepirid.
English: The impact of UGT inhibitors on the pharmacokinetics of ertugliflozin has not been studied clinically, but potential increase in ertugliflozin exposure due to UGT inhibition is not considered to be clinically relevant.
Danish: Indvirkningen af UGT-hæmmere på ertugliflozins farmakokinetik er ikke undersøgt i kliniske studier, men en potentiel stigning i eksponeringen for ertugliflozin som følge af UGT-hæmning anses ikke for at være klinisk relevant.
English: Ertugliflozin may increase the risk of hypoglycaemia when used in combination with insulin and/or an insulin secretagogue.
Danish: Ertugliflozin kan øge risikoen for hypoglykæmi ved anvendelse i kombination med insulin og/eller et insulinsekretionsfremkaldende stof.
English: In case of conditions that may lead to fluid loss (e.g., gastrointestinal illness), careful monitoring of volume status (e.g., physical examination, blood pressure measurements, laboratory tests including haematocrit) and electrolytes is recommended for patients receiving ertugliflozin.
Danish: Ved tilstande med risiko for væsketab (f.eks. mave-tarm-sygdom), anbefales nøje monitorering af volumenstatus (f.eks. objektiv undersøgelse, blodtryksmålinger, laboratorietest, herunder hæmatokrit) og elektrolytter hos patienter, der får ertugliflozin.
English: The efficacy of ertugliflozin is dependent on renal function, and efficacy is reduced in patients who have moderate renal impairment and likely absent in patients with severe renal impairment (see section 4.2).
Danish: Ertugliflozins virkning afhænger af nyrefunktionen, og virkningen er nedsat hos patienter med moderat nedsat nyrefunktion og sandsynligvis fraværende hos patienter med svært nedsat nyrefunktion (se pkt.
English: Interaction studies conducted in healthy subjects, using a single dose design, suggest that the pharmacokinetics of ertugliflozin are not altered by sitagliptin, metformin, glimepiride, or simvastatin.
Danish: Interaktionsstudier udført med raske forsøgspersoner og med anvendelse af et enkeltdosisdesign tyder på, at ertugliflozins farmakokinetik ikke ændres af sitagliptin, metformin, glimepirid eller simvastatin.
English: More frequent renal function monitoring is recommended in patients with a GFR below 60 ml/min.
Danish: Hyppigere monitorering af nyrefunktionen anbefales hos patienter med GFR under 60 ml/min.
English: When ertugliflozin was administered to juvenile rats from post-natal day (PND) 21 to PND 90, a period of renal development corresponding to the late second and third trimesters of human pregnancy, increased kidney weights, dilatation of the renal pelvis and tubules, and renal tubular mineralization were seen at an exposure 13 times the maximum clinical dose of 15 mg/day, based on AUC.
Danish: Når ertugliflozin blev administreret til unge rotter fra postnatal dag (PND) 21 til PND 90, blev der observeret en periode med nyreudvikling svarende til slutningen af det andet og det tredje trimester af en human graviditet, øget nyrevægt, dilatation af nyrebækkenet og de renale tubuli samt mineralisering af de renale tubuli ved en eksponering på 13 gange den maksimale kliniske dosis på 15 mg/dag, baseret på AUC.
English: Some medicinal products can adversely affect renal function, which may increase the risk of lactic acidosis, e.g., NSAIDs, including selective cyclo-oxygenase (COX) II inhibitors, angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor antagonists and diuretics, especially loop diuretics.
Danish: Kombinationsbehandlinger, der kræver forholdsregler ved anvendelse Visse lægemidler kan påvirke nyrefunktionen negativt, hvilket kan øge risikoen for laktacidose, f.eks. NSAID, herunder selektive cyklooxygenase (COX) II-hæmmere, angiotensinkonverterende enzym (ACE)-hæmmere, angiotensin II-receptorantagonister og diuretika, især loop-diuretika.
English: The efficacy and safety of ertugliflozin in combination with metformin have been studied in 4 multi-centre, randomised, double-blind, placebo- and active comparator-controlled, Phase 3 clinical studies involving 3,643 patients with type 2 diabetes.
Danish: Ertugliflozins virkning og sikkerhed i kombination med metformin er blevet undersøgt i 4 randomiserede, dobbeltblindede placebo- og aktiv komparator-kontrollerede kliniske multicenterstudier i fase 3 med 3.643 patienter med type 2-diabetes.
English: Packs of 14, 28, 56, 60, 168, and 180 film-coated tablets in non-perforated blisters and multipacks containing 196 (4 packs of 49) film-coated tablets in non-perforated blisters.
Danish: Pakninger med 14, 28, 56, 60, 168 og 180 filmovertrukne tabletter i ikke-perforerede blistre og multipakninger med 196 (4 pakninger a 49) filmovertrukne tabletter i ikke-perforerede blistre.