FrancophonIA/ELRC3.0 huggingface dataset:
English: Do not change your dose unless your doctor has told you to.
Danish: Du må ikke ændre dosis, medmindre lægen har bedt dig om det.
English: Alternative methods should be used to monitor glycaemic control.
Danish: Der skal anvendes alternative metoder til monitorering af glykæmisk kontrol.
English: Talk with your doctor about the best way to feed your baby if you take this medicine.
Danish: Tal med lægen om, hvordan du bedst giver dit barn mad, hvis du tager dette lægemiddel.
English: Subgroup analysis
Danish: Subgruppeanalyse
English: You may be more likely to get dehydrated if you:
Danish: Du vil have større tendens til at blive dehydreret, hvis du:
English: Adverse reactions listed below are classified according to frequency and system organ class (SOC).
Danish: Bivirkningerne nedenfor er inddelt efter hyppighed og systemorganklasse (SOC).
English: • The dose of Segluromet that you take will depend on your condition and the amount of ertugliflozin and metformin needed to control your blood sugar.
Danish: • Den dosis af Segluromet, som du skal tage, afhænger af din tilstand og den mængde ertugliflozin og metformin, du har behov for til at kontrollere dit blodsukker.
English: Do not stop taking this medicine without talking to your doctor.
Danish: Du må ikke stoppe med at tage dette lægemiddel uden at have talt med lægen.
English: This may occur regardless of blood glucose level.
Danish: Dette kan forekomme uanset blodsukkerniveauet.
English: As an underlying mechanism has not been established, risk factors, apart from general risk factors, for amputation are unknown.
Danish: Da den underliggende mekanisme ikke er blevet fastlagt, kendes risikofaktorerne, bortset fra de generelle risikofaktorer for amputation, ikke.
English: There is limited experience with Segluromet in patients ≥ 75 years of age.
Danish: Der er begrænset erfaring med Segluromet hos patienter i alderen ≥ 75 år.
English: Your doctor will tell you how to treat low blood sugar and what to do if you have any of the symptoms or signs below.
Danish: Din læge vil fortælle dig, hvordan du skal behandle lavt blodsukker, og hvad du skal gøre, hvis du oplever et eller flere af følgende tegn eller symptomer.
English: General introduction
Danish: Generel introduktion
English: such as ibuprofen and celecoxib).
Danish: hæmmere, såsom ibuprofen og celecoxib).
English: If you are pregnant, talk with your doctor about the best way to control your blood sugar while you are pregnant.
Danish: Hvis du er gravid, skal du tale med lægen om, hvordan dit blodsukker bedst kontrolleres under graviditeten.
English: Ertugliflozin glucuronides had no effect on these isoforms.
Danish: Ertugliflozin-glukuronider havde ingen indvirkning på disse isoformer.
English: The maximum daily dose of metformin should preferably be divided into 2-3 daily doses.
Danish: Den maksimale daglige metformindosis skal helst fordeles på 2-3 daglige doser.
English: Metabolism is the primary clearance mechanism for ertugliflozin.
Danish: Metabolisering er den primære clearance-mekanisme for ertugliflozin.
English: • Segluromet can be used alone or with some other medicines that lower blood sugar.
Danish: • Segluromet kan anvendes alene eller sammen med andre lægemidler, der sænker blodsukkeret.
English: • take other diabetes medicines; you are more likely to get low blood sugar with certain medicines.
Danish: • tager anden diabetesmedicin; Du vil være mere tilbøjelig til at få lavt blodsukker med visse lægemidler.
English: Results in the in vivo mouse micronucleus test were also negative.
Danish: Resultaterne af in vivo muse-mikronukleustest var også negative.
English: Your blood sugar levels may increase if you stop the medicine.
Danish: Dit blodsukker kan stige, hvis du holder op med at tage lægemidlet.
English: There is no information regarding the presence of ertugliflozin in human milk, the effects on the breast-fed infant, or the effects on milk production.
Danish: Der foreligger ingen oplysninger om tilstedeværelse af ertugliflozin i human mælk, virkningen på det ammede barn eller virkningen på mælkeproduktionen.
English: See subsections below for additional information.
Danish: † Se nedenstående underafsnit for yderligere oplysninger.
English: In this population, the incidence of severe hypoglycaemia was 0.4% in each group.
Danish: I denne population var incidensen af svær hypoglykæmi 0,4% i hver gruppe.
English: Patients with moderate renal impairment at baseline had larger mean changes that did not return to baseline at Week 26; these changes reversed after treatment discontinuation.
Danish: Patienter med moderat nedsat nyrefunktion ved baseline havde større gennemsnitlige ændringer, som ikke vendte tilbage til baseline-niveau i uge 26; disse ændringer reverserede efter seponering af behandlingen.
English: Contact your doctor as soon as possible if you notice the following side effects:
Danish: Kontakt lægen hurtigst muligt, hvis du bemærker følgende bivirkninger:
English: The effects on kidney and bone did not fully reverse after the 1-month recovery period.
Danish: Indvirkning på nyrer og knogler reverseredes ikke helt efter den 1 måned lange restitutionsperiode.
English: Treatment with Segluromet may be restarted when the ketone values are normal and the patient's condition has stabilised.
Danish: Behandlingen med Segluromet kan genoptages, når ketonstofværdierne er normale, og patientens tilstand er stabiliseret.
English: These data reflect exposure of 1,029 patients to ertugliflozin with a mean exposure duration of approximately 25 weeks.
Danish: Disse data afspejler 1.029 patienters eksponering for ertugliflozin med en gennemsnitlig eksponeringsvarighed på ca. 25 uger.
English: Non-inferiority is declared when the upper bound of the two-sided 95% confidence interval (CI) for the mean difference is less than 0.3%.
Danish: Non-inferioritet erklæres, når den øvre grænse af det tosidede 95%-konfidensinterval (CI) for den gennemsnitlige forskel er under 0,3%.
English: SGLT2 inhibitors should be used with caution in these patients.
Danish: SGLT2hæmmere skal anvendes med forsigtighed hos disse patienter.
English: Do not take Segluromet if any of the above apply to you.
Danish: Tag ikke Segluromet hvis noget af ovenstående gælder for dig.
English: Serious diabetic ketoacidosis occurred rarely.
Danish: Alvorlig diabetisk ketoacidose forekom kun sjældent.
English: In patients at increased risk of further progression of renal impairment and in the elderly, renal function should be assessed more frequently, e.g., every 3-6 months.
Danish: Hos patienter med øget risiko for yderligere progression af nedsat nyrefunktion og hos ældre bør nyrefunktionen vurderes oftere, f.eks. hver 3.-6. måned.
English: • fast and deep breathing
Danish: • hurtig og dyb vejrtrækning
English: Hispanic or Latino patients comprised 15.6% to 34.5% of the population.
Danish: Latinamerikanske patienter udgjorde 15,6 - 34,5% af populationen.
English: Renal clearance is approximately 3.5 times greater than creatinine clearance, which indicates that tubular secretion is the major route of metformin elimination.
Danish: Renal clearance er ca. 3,5 gange større end kreatinin-clearance, hvilket tyder på, at tubulær sekretion er en væsentlig eliminationsvej for metformin.
English: , Vitamin B12 deficiency
Danish: , vitamin B12-mangel
English: • Segluromet can be used instead of taking both ertugliflozin and metformin as separate tablets.
Danish: • Segluromet kan tages i stedet for at tage både ertugliflozin og metformin som separate tabletter.
English: This may cause anaemia (low levels of red blood cells).
Danish: Dette kan medføre anæmi (lavt indhold af røde blodlegemer).
English: Metformin is present in human breast milk.
Danish: Metformin er til stede i human brystmælk.
English: During treatment with Segluromet, your doctor will check your kidney function at least once a year or more frequently if you are elderly and/or if you have worsening kidney function.
Danish: Under behandlingen med Segluromet vil lægen kontrollere din nyrefunktion mindst en gang om året eller hyppigere, hvis du er ældre, eller hvis din nyrefunktion bliver dårligere.
English: • Metformin belongs to a group of medicines called biguanides.
Danish: • Metformin tilhører en lægemiddelklasse, der kaldes biguanider.
English: • Take one tablet twice daily.
Danish: • Tag en tablet to gange dagligt.
English: Steady-state is reached after 4 to 6 days of once-daily dosing with ertugliflozin.
Danish: Steady-state nås efter 4-6 dage med dosering af ertugliflozin en gang dagligt.
English: In three placebo-controlled studies, ertugliflozin resulted in statistically significant reductions in FPG.
Danish: I tre placebokontrollerede studier medførte ertugliflozin statistisk signifikante fald i FPG.
English: CYP-mediated (oxidative) metabolism of ertugliflozin is minimal (12%).
Danish: CYP-medieret (oxidativ) metabolisering for ertugliflozin er minimal (12%).
English: Do not use this medicine if the packaging is damaged or shows signs of tampering.
Danish: Brug ikke lægemidlet, hvis pakningen er beskadiget eller viser tegn på, at den har været åbnet.
English: Since human kidney maturation occurs in utero and during the first 2 years of life when exposure from breast-feeding may occur, a risk to newborns/infants cannot be excluded.
Danish: Da modningen af de humane nyrer sker in utero og i løbet af de første 2 leveår, hvor eksponering fra amning kan finde sted, kan en risiko for nyfødte/spædbørn ikke udelukkes.
English: Low blood sugar (hypoglycaemia; common)
Danish: Lavt blodsukker (hypoglykæmi; almindelig)
English: In case of swallowing difficulties, the tablet could be broken or crushed as it is an immediate-release dosage form.
Danish: I tilfælde af synkebesvær kan tabletten deles eller knuses, da det er en doseringsform med øjeblikkelig frigivelse.
English: • if you have severely reduced kidney function or need dialysis.
Danish: • hvis du har alvorligt nedsat nyrefunktion eller har behov for dialyse.
English: Talk to your doctor, pharmacist, or nurse before and while taking Segluromet, if you:
Danish: Kontakt lægen, apotekspersonalet eller sygeplejersken, før og mens du tager Segluromet, hvis du:
English: As precautionary measures, consideration should be given to carefully monitoring patients with a higher risk for amputation events and counselling patients about the importance of routine preventative foot care and maintaining adequate hydration.
Danish: Som en forebyggende foranstaltning bør der træffes foranstaltninger med henblik på tæt overvågning af patienter med øget risiko for amputation og at rådgive patienterne om vigtigheden af rutinemæssig forebyggende fodpleje og opretholdelse af passende hydrering.
English: Its pharmacologic mechanisms of action are different from other classes of oral antihyperglycaemic agents.
Danish: Dets farmakologiske virkningsmekanismer er forskellige fra andre klasser af orale antihyperglykæmiske stoffer.
English: Experience in New York Heart Association (NYHA) class I-II is limited, and there is no experience in clinical studies with ertugliflozin in NYHA class III-IV.
Danish: Der er begrænset erfaring med NYHA (New York Heart Association)-klasse I-II, og der er ingen erfaring fra kliniske studier med ertugliflozin i NYHA-klasse III-IV.
English: • Your doctor will prescribe the right dose for you.
Danish: • Lægen vil ordinere den dosis, der passer bedst til dig.
English: Tél: + 33 (0) 1 80 46 40 40
Danish: Tlf.: + 33 (0) 1 80 46 40 40
English: Elderly patients may be at an increased risk of volume depletion.
Danish: Ældre patienter kan have en større risiko for volumendepletering.
English: common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data).
Danish: Hyppighed er defineret på følgende måde: Meget almindelig (≥ 1/10), Almindelig (≥ 1/100 til < 1/10), Ikke almindelig (≥ 1/1.000 til < 1/100), Sjælden (≥ 1/10.000 til < 1/1.000), Meget sjælden (< 1/10.000) og Ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: However, if it is nearly time for your next dose, skip the missed dose and go back to your regular schedule.
Danish: Hvis det imidlertid næsten er tid til den næste dosis, skal du springe den glemte dosis over og tage den næste dosis som normalt.
English: • if you have recently had a heart attack or have severe circulatory problems, such as ‘shock' or breathing difficulties.
Danish: • hvis du for nylig har haft et hjerteanfald eller har alvorlige kredsløbsproblemer, herunder shock eller vejrtrækningsbesvær.
English: Segluromet should be taken orally twice daily with meals to reduce the gastrointestinal adverse reactions associated with metformin.
Danish: Segluromet skal tages oralt to gange dagligt sammen med et måltid for at mindske de gastrointestinale bivirkninger, som er forbundet med metformin.
English: If you forget a dose, take it as soon as you remember.
Danish: Hvis du glemmer en dosis, skal du tage den, så snart du kommer i tanke om det.
English: If no adequate strength of Segluromet is available, individual monocomponents should be used instead of the fixed-dose combination.
Danish: Hvis der ikke findes en passende styrke af Segluromet, bør enkeltstofferne anvendes enkeltvist i stedet for fastdosiskombinationen.
English: Lactic acidosis is a medical emergency and must be treated in a hospital.
Danish: Laktacidose er en akut medicinsk tilstand, der skal behandles på et hospital.
English: In vitro assessment of ertugliflozin
Danish: In vitro-vurdering af ertugliflozin
English: • have ever had serious heart disease or if you have had a stroke.
Danish: • nogensinde har haft alvorlig hjertesygdom, eller hvis du har haft et slagtilfælde.
English: If any of the above apply to you (or you are not sure), tell your doctor.
Danish: Hvis noget af ovenstående gælder for dig (eller hvis du er i tvivl), skal du tale med lægen.
English: Hypotension/Volume depletion
Danish: Hypotension/volumendepletering
English: When starting or using such products in combination with metformin, close monitoring of renal function is necessary.
Danish: Ved initiering eller anvendelse af sådanne præparater i kombination med metformin skal nyrefunktionen monitoreres tæt.
English: Organic cation transporters (OCT) Metformin is a substrate of both transporters OCT1 and OCT2.
Danish: Organiske kation-transportører (OCT) Metformin er et substrat for både OCT1- og OCT2-transportører.
English: Patients should not take two doses of Segluromet at the same time.
Danish: Patienten må ikke tage en dobbeltdosis Segluromet på samme dag.
English: If Fournier's gangrene is suspected, Segluromet should be discontinued and prompt treatment (including antibiotics and surgical debridement) should be instituted.
Danish: Hvis der er mistanke om Fourniers gangræn, bør Segluromet seponeres, og øjeblikkelig behandling (herunder antibiotika og kirurgisk debridement) bør iværksættes.
English: There were no clinically meaningful differences in the ertugliflozin Cmax values among the different renal function groups.
Danish: Der var ingen klinisk betydningsfulde forskelle i Cmax-værdierne for ertugliflozin mellem de forskellige nyrefunktionsgrupper.
English: If a dose is missed, it should be taken as soon as the patient remembers.
Danish: Hvis en dosis glemmes, skal den tages, så snart patienten kommer i tanke om det.
English: The primary assessment of safety was conducted in a pool of three 26-week, placebo-controlled trials.
Danish: Den primære sikkerhedsvurdering blev udført som en poolet analyse af tre 26-ugers, placebokontrollerede studier.
English: Segluromet with alcohol
Danish: Brug af Segluromet sammen med alkohol
English: There are limited data from the use of ertugliflozin in pregnant women.
Danish: Der er begrænsede data fra anvendelse af ertugliflozin til gravide kvinder.
English: • changes in urination, including urgent need to urinate more often, in larger amounts, or at night
Danish: • ændret vandladning, herunder pludselig og hyppigere trang til at lade vandet, i større mængder eller om natten
English: • unusual sleepiness or tiredness
Danish: • usædvanlig søvnighed eller træthed
English: Ertugliflozin is a substrate of P-glycoprotein (P-gp) and breast cancer resistance protein (BCRP) transporters.
Danish: Ertugliflozin er et substrat for P-glycoprotein (P-gp) og brystcancer-resistent protein (BCRP)transportører.
English: The mechanism for the small increases in simvastatin and simvastatin acid is unknown and is not perpetrated through OATP inhibition by ertugliflozin.
Danish: Mekanismen for de små stigninger i simvastatin og simvastatinsyre er ukendt og sker ikke via OATP-hæmning ved ertugliflozin.
English: • increased levels of “ketone bodies” in your urine or blood
Danish: • øget indhold af “ketonstoffer” i urinen eller blodet
English: Repeat-dose oral toxicity studies were conducted in mice, rats, and dogs for up to 13, 26, and 39 weeks, respectively.
Danish: Orale toksicitetsstudier med gentagne doser blev udført med mus, rotter og hunde i op til henholdsvis 13, 26 og 39 uger.
English: The mean daily dose of glimepiride was 3.0 mg (see Table 5).
Danish: Den daglige gennemsnitlige dosis glimepirid var 3,0 mg (se tabel 5).
English: The effect of Segluromet on fertility in humans has not been studied.
Danish: Segluromets indvirkning på fertilitet hos mennesker er ikke blevet undersøgt.
English: Following oral administration, approximately 90% of the absorbed drug is eliminated via the renal route within the first 24 hours, with a plasma elimination half-life of approximately 6.2 hours.
Danish: Efter oral administration elimineres ca. 90% af det absorberede lægemiddel via nyrerne inden for de første 24 timer med en plasmaeliminationshalveringstid på ca. 6,2 timer.
English: If necessary, the dose of the antihyperglycaemic medicinal product should be adjusted during therapy with the other medicinal product and on its discontinuation.
Danish: Hvis det er nødvendigt, bør doseringen af det antihyperglykæmiske lægemiddel justeres under behandling med det andet lægemiddel og ved seponering af dette.
English: In Phase 3 clinical trials, ertugliflozin was administered without regard to meals.
Danish: I kliniske fase 3-studier blev ertugliflozin administreret uden hensyntagen til måltider.
English: Multipack: 196 (4 packs of 49) film-coated tablets
Danish: Multipakning: 196 (4 pakninger a 49) filmovertrukne tabletter
English: • change in taste
Danish: • ændret smag
English: If you need to have an injection of a contrast medium that contains iodine into your bloodstream, for example, in the context of an X-ray or scan, you must stop taking Segluromet before or at the time of the injection.
Danish: Hvis du skal have sprøjtet et kontrastmiddel, som indeholder jod, ind i blodet, for eksempel i forbindelse med en røntgenundersøgelse eller scanning, skal du stoppe med at tage Segluromet forud for eller på tidspunktet for injektionen.
English: The blood-to-plasma concentration ratio of ertugliflozin is 0.66.
Danish: Blod-til-plasma-koncentrationsforholdet for ertugliflozin er 0,66.
English: In a number of cases, the presentation of the condition was atypical with only moderately increased blood glucose values, below 14 mmol/l (250 mg/dl).
Danish: I en række tilfælde fremstod tilstanden atypisk med kun moderat forhøjet blodglucose under 14 mmol/l (250 mg/dl).
English: Your doctor may decide to temporarily or permanently stop your treatment with Segluromet.
Danish: Lægen kan beslutte at stoppe din behandling med Segluromet midlertidigt eller permanent.
English: Moderate hepatic impairment (based on the Child-Pugh classification) did not result in an increase in exposure of ertugliflozin.
Danish: Moderat nedsat leverfunktion (baseret på Child-Pugh-klassificering) medførte ikke en stigning i eksponeringen for ertugliflozin.
English: Patients [N (%)] with HbA1c < 7% 66 (26.4)
Danish: Patienter [N (%)] med HbA1c < 7% 66 (26,4)
English: * N includes all randomised, treated patients who had at least one measurement of the outcome variable.
Danish: * N omfatter alle randomiserede, behandlede patienter, som har mindst en måling af udfaldsvariablen.
English: Ask about ways to prevent dehydration.
Danish: hvordan du undgår dehydrering.
English: A clinically relevant effect with other inducers (e.g., carbamazepine, phenytoin, phenobarbital) is not expected.
Danish: Der forventes ingen klinisk relevant effekt med andre induktorer (f.eks. carbamazepin, phenytoin, phenobarbital).
English: A limited amount of data suggests the use of metformin in pregnant women is not associated with an increased risk of congenital malformations.
Danish: En begrænset mængde data tyder på, at anvendelse af metformin til gravide kvinder ikke er forbundet med øget risiko for medfødte misdannelser.
English: Metformin is dialyzable with a clearance of up to 170 ml/min under good haemodynamic conditions.
Danish: Metformin kan dialyseres med en clearance på op til 170 ml/min under gode hæmodynamiske forhold.
English: • You need to keep following your food and exercise plan while taking Segluromet.
Danish: • Du skal fortsætte med at følge din kost- og motionsplan, mens du tager Segluromet.
English: A serious soft tissue infection of the genitals or the area between the genitals and the anus (see section “Warnings and precautions” for symptoms).
Danish: En alvorlig bløddelsinfektion i kønsdelene eller området mellem kønsdelene og anus (se punktet “Advarsler og forsigtighedsregler” for symptomer).
English: • have or have had yeast infections of the vagina or penis.
Danish: • har eller har haft svampeinfektion i skeden eller penis.
English: Glimepiride was initiated at 1 mg/day and titrated up to a maximum dose of 6 or 8 mg/day (depending on maximum approved dose in each country) or a maximum tolerated dose or down-titrated to avoid or manage hypoglycaemia.
Danish: Glimepirid blev initieret ved 1 mg/dag og optitreret til en maksimal dosis på 6 eller 8 mg/dag (afhængigt af den maksimale godkendte dosis i hvert land) eller en maksimal tolereret dosis eller nedtitreret for at undgå eller behandle hypoglykæmi.
English: There is no clinical experience in patients with Child-Pugh class C (severe) hepatic impairment.
Danish: Der er ingen klinisk erfaring med patienter med nedsat leverfunktion af Child-Pugh-klasse C (svær).
English: • feeling dizzy, light-headed, or weak, especially when you stand up
Danish: • svimmelhed, ørhed eller mathed, især når du rejser dig op
English: p< 0.001 compared to control group.
Danish: p < 0,001 sammenlignet med kontrolgruppe.
English: • blood tests may show changes in the amount of total and bad cholesterol (called LDL - a type of fat in your blood)
Danish: • blodprøver kan vise ændringer i mængden af totalt og dårligt kolesterol (kaldet LDL - en type fedt i blodet)
English: This finding was attributed to carbohydrate malabsorption leading to altered calcium homeostasis and was not considered relevant to human risk.
Danish: Dette fund blev tilskrevet malabsorption af kulhydrat, hvilket medførte ændret kalciumhomøostase, og blev ikke anset for relevant for risikoen hos mennesker.
English: • Metformin works by inhibiting sugar (glucose) production in the liver.
Danish: • Metformin virker ved at hæmme produktionen af sukker (glucose) i leveren.
English: The requirements for submission of PSURs for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Danish: Kravene for fremsendelse af PSUR'er for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF, og alle efterfølgende opdateringer offentliggjort på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.
English: • Ertugliflozin belongs to a group of medicines called sodium glucose co-transporter-2 (SGLT2)
Danish: • Ertugliflozin tilhører en lægemiddelklasse kaldet natrium-glucose-co-transporter 2 (SGLT2)
English: A GFR should be assessed before initiation of treatment with metformin-containing products and at least annually thereafter.
Danish: GFR skal bestemmes, inden behandling med metforminholdige præparater iværksættes og derefter mindst en gang om året.