FrancophonIA/ELRC3.0 huggingface dataset:
English: In T-ALL the abnormal cells are mainly in the blood and bone marrow, and in T-LBL they are mainly in the lymphatic system (lymph nodes or thymus gland).
Danish: Ved T-LBL findes de hovedsagelig i lymfesystemet (i lymfeknuderne eller brislen).
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Atriance have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Atriance.
English: How does Atriance work?
Danish: Hvordan virker Atriance?
English: Patients receiving Atriance should be monitored regularly for changes in blood cell counts and should receive adequate hydration if they are at risk of tumour lysis syndrome (a complication due to the breakdown of cancer cells).
Danish: Desuden bør de have passende væsketilførsel, hvis der er risiko for tumorlysis-syndrom (en komplikation, der skyldes nedbrydningen af kræftceller).
English: What benefits of Atriance have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Atriance?
English: However, try to take it at the same time each day.
Danish: Prøv imidlertid at tage den på samme tidspunkt hver dag.
English: Frequency not known (cannot be estimated from the available data)
Danish: Hyppighed ikke kendt (kan ikke vurderes ud fra tilgængelige data)
English: No patient was older than 85 years.
Danish: Ingen patient var ældre end 85 år.
English: A risk to newborns or infants cannot be excluded.
Danish: En risiko for nyfødte/spædbørn kan ikke udelukkes.
English: The signs of too low blood sugar may include:
Danish: Tegnene på for lavt blodsukker kan være:
English: Effects related to the individual active substances are described below.
Danish: Virkninger, der er forbundet med de to aktive stoffer, er beskrevet nedenfor.
English: No special requirements for disposal.
Danish: Ingen særlige krav til bortskaffelse.
English: For weight, baseline weight is also included.
Danish: For vægt er baseline-vægt også inkluderet.
English: Diet and exercise can help your body to use its blood sugar better.
Danish: Diæt og motion kan hjælpe din krop med at bruge blodsukkeret bedre.
English: Systemic exposure of each metabolite was less than 10 % of total drug-related material.
Danish: Den systemiske eksponering for de enkelte metabolitter var mindre end 10 % af det samlede lægemiddelrelaterede materiale.
English: Your doctor may decide to temporarily or permanently stop your treatment with this medicine.
Danish: Lægen kan beslutte at stoppe din behandling med dette lægemiddel midlertidigt eller permanent.
English: (See sections 4.2, 4.4, 4.5 and 5.1 for available data on combinations studied)
Danish: 4.2, 4.4, 4.5 og 5.1 for tilgængelige data om undersøgte kombinationer)
English: • if you have type 1 diabetes (your body does not produce any insulin).
Danish: • hvis du har type 1-diabetes (din krop danner ikke insulin).
English: (including pyelonephritis and urosepsis)
Danish: (herunder pyelonefritis og urosepsis)
English: Do not stop taking this medicine without first consulting your doctor.
Danish: Du må ikke holde op med at tage dette lægemiddel uden først at have rådført dig med din læge.
English: The tablets should be swallowed whole with water.
Danish: Tabletterne bør synkes hele sammen med vand.
English: Warnings and precautions Talk to your doctor, before taking this medicine, and during treatment:
Danish: Advarsler og forsigtighedsregler Kontakt lægen, før du tager dette lægemiddel og under behandlingen:
English: What to do if you forget to take a tablet depends on how long it is until your next dose:
Danish: Hvad du skal gøre, hvis du har glemt at tage en tablet, afhænger af, hvor lang tid der er til din næste dosis.
English: In clinical trials, patients were treated for up to 24 or 52 weeks.
Danish: I de kliniske studier blev patienterne behandlet op til 24 eller 52 uger.
English: The next dose should be taken at the usual time.
Danish: Den næste dosis skal tages på det sædvanlige tidspunkt.
English: For FPG, baseline FPG is also included.
Danish: For FPG er baseline-FPG også inkluderet.
English: Your doctor will tell you how to treat low blood sugar levels and what to do if you get any of the signs above.
Danish: Din læge vil fortælle dig, hvordan du skal forholde dig ved for lavt blodsukker, og hvad du skal gøre, hvis du mærker et eller flere af ovenstående tegn.
English: Type 2 diabetes is a condition that comes from both your genes and your lifestyle.
Danish: Type 2-diabetes er en sygdom, der både skyldes dine gener og din livsstil.
English: It does this by blocking a protein called DPP-4.
Danish: Det sker ved at blokere et protein, der kaldes DPP-4.
English: • if you have serious kidney problems.
Danish: • hvis du har alvorlige nyreproblemer.
English: Thereafter, plasma concentrations declined in a biphasic manner with a rapid distribution phase and a relatively slow terminal phase.
Danish: Derefter faldt plasmakoncentrationen på en bifasisk måde med en hurtig fordelingsfase og en relativt langsom terminalfase.
English: Overall, the effects on HbA1c reduction observed at 24 weeks were sustained at week 52.
Danish: Overordnet var den virkning på HbA1c-reduktion, der blev observeret ved uge 24, opretholdt ved uge 52.
English: Renal clearance at steady-state was approximately 70 mL/min.
Danish: Den renale clearance ved steady state var ca. 70 ml/min.
English: • if you are being sick, have diarrhoea or fever, or if you are not able to eat or drink.
Danish: • hvis du kaster op, har diarré eller får feber, eller hvis du ikke kan spise eller drikke.
English: The incidence of confirmed hypoglycaemic events was low (< 1,5 %).
Danish: Forekomsten af bekræftede hypoglykæmiske hændelser var lav (< 1,5 %).
English: The clinical relevance of this finding remains uncertain.
Danish: Den kliniske relevans af dette fund forbliver usikker.
English: Safety data from this study was in line with previous known safety profile of linagliptin.
Danish: Sikkerhedsdata fra dette studie var i overensstemmelse med den tidligere kendte sikkerhedsprofil af linagliptin.
English: Table 5 Treatment effect for the primary composite endpoint, its components and mortality
Danish: Tabel 5 Behandlingens virkning, hvad angår det primære sammensatte endepunkt, endepunktets komponenter og mortalitet
English: The effect of Glyxambi may be reduced.
Danish: Virkningen af Glyxambi kan blive reduceret.
English: Use with medicinal products known to cause hypoglycaemia
Danish: Anvendelse sammen med lægemidler, der er kendt for at forårsage hypoglykæmi
English: The apparent steady-state volume of distribution was estimated to be 73.8 L based on the population pharmacokinetic analysis.
Danish: Det tilsyneladende fordelingsvolumen ved steady state blev anslået til at være 73,8 l baseret på den farmakokinetiske populationsanalyse.
English: Frequency categories are defined as very common (≥ 1/10), 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) and not known (cannot be estimated from the available data).
Danish: Hyppighedskategorierne er defineret som 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: The observed increase in urine volume was not dose-dependent.
Danish: Den observerede forøgelse af urinvolumenet var ikke dosisafhængig.
English: It is not known if DKA is more likely to occur with higher doses of empagliflozin.
Danish: Det vides ikke, om der er større sandsynlighed for DKA ved højere doser af empagliflozin.
English: Systemic exposure of empagliflozin increased in a dose proportional manner.
Danish: Den systemiske eksponering af empagliflozin steg på en dosisproportional måde.
English: Patients should be assessed for ketoacidosis immediately if these symptoms occur, regardless of blood glucose level.
Danish: Patienterne skal straks evalueres for ketoacidose, hvis de får disse symptomer, uanset blodglucoseniveau.
English: The metformin dose should be continued.
Danish: Metformindosen skal fastholdes.
English: These changes were not considered to be clinically meaningful.
Danish: Ændringerne blev ikke betragtet som klinisk relevante.
English: * PY=patient years ** Test on non-inferiority to demonstrate that the upper bound of the 95% CI for the hazard ratio is less than 1.3
Danish: * PY = patientår ** Test for non-inferioritet for at vise, at den øvre grænse af det 95 % CI for hazard ratio er under 1,3
English: Both tumours are common in rats and are unlikely to be relevant to humans.
Danish: Begge tumorer er almindelige hos rotter, og det er ikke sandsynligt, at fundet har relevans for mennesker.
English: At baseline, 74 % of patients were being treated with metformin, 48 % with insulin, and 43 % with a sulfonylurea.
Danish: Ved baseline blev 74 % af patienterne behandlet med metformin, 48 % med insulin og 43 % med et sulfonylurinstof.
English: Improvement of surrogate markers of beta cell function including Homeostasis Model Assessment β (HOMA β) was noted.
Danish: Der blev set en forbedring i surrogatmarkører for beta-cellefunktionen, herunder Homeostasis Model Assessment β (HOMA-β).
English: Incretins are secreted at a low basal level throughout the day and levels rise immediately after meal intake.
Danish: Inkretiner secerneres i et lavt basisniveau i dagtimerne, og niveauet øges umiddelbart efter et måltid.
English: • prior to Glyxambi initiation and periodically during treatment, i.e. at least yearly,
Danish: • før initiering af Glyxambi og periodisk under behandlingen, dvs. mindst én gang om året
English: Possible signs are listed in section 4, ‘Possible side effects'.
Danish: Tegnene er anført i afsnit 4 "Bivirkninger".
English: Adverse reactions marked with an asterisk (*) are further discussed in section “Description of selected adverse reactions” below.
Danish: Bivirkninger, der er markeret med en stjerne (*), beskrives yderligere i punktet "Beskrivelse af udvalgte bivirkninger" herunder.
English: Because of how this medicine works, your urine will test positive for sugar while you are taking this medicine.
Danish: På grund af den måde, dette lægemiddel virker på, vil prøver for sukker i urinen være positive, mens du tager lægemidlet.
English: • prior to initiation of any concomitant medicinal product that may have a negative impact on renal function.
Danish: • før initiering af behandling med et andet lægemiddel, som kan have en negativ virkning på nyrefunktionen.
English: Therefore, assessment of renal function is recommended:
Danish: Derfor anbefales monitorering af nyrefunktionen:
English: The absolute bioavailability of linagliptin is approximately 30 %.
Danish: Linagliptins absolutte biotilgængelighed er ca. 30 %.
English: Empagliflozin cardiovascular outcome (EMPA-REG OUTCOME) study
Danish: Empagliflozin kardiovaskulært endepunktsstudie (EMPA-REG OUTCOME)
English: SGLT2 is highly expressed in the kidney, whereas expression in other tissues is absent or very low.
Danish: SGLT2 er i stort omfang udbredt i nyrerne, hvorimod udbredelsen i andre væv er ikke-eksisterende eller meget lav.
English: Do not use this medicine after the expiry date which is stated on the blister and the carton after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står efter EXP på blisterkort og pakning.
English: Use in patients at risk for volume depletion
Danish: Anvendelse til patienter med risiko for volumendepletering
English: Diabetic ketoacidosis (DKA)
Danish: Diabetisk ketoacidose (DKA)
English: • If it is 12 hours or more until your next dose, take Glyxambi as soon as you remember.
Danish: • Hvis der er 12 timer eller mere til din næste dosis, skal du tage Glyxambi, så snart du kommer i tanker om det.
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: • if you encounter blistering of the skin it may be a sign for a condition called bullous pemphigoid.
Danish: • hvis der dannes blistre på din hud, kan det være et tegn på en tilstand, der kaldes bulløs pemfigoid.
English: Your doctor may need to change your treatment.
Danish: Lægen vil måske ændre din behandling.
English: • about what you can do to prevent dehydration
Danish: • så I kan drøfte, hvad du kan gøre for at forebygge væskemangel (dehydrering)
English: Co-administration with known inducers of UGT enzymes should be avoided because of a risk of decreased efficacy of empagliflozin.
Danish: Administration sammen med kendte UGT-enzym-induktorer bør undgås på grund af risiko for nedsat virkning af empagliflozin.
English: Strong pseudo-allergic reactions were observed in dogs at medium doses, secondarily causing cardiovascular changes, which were considered dog-specific.
Danish: Udtalte pseudo-allergiske reaktioner blev observeret hos hunde ved mellemstore doser og medførte sekundært kardiovaskulære forandringer, som blev anset for at være specifikke for hunde.
English: A significantly higher incidence of malignant lymphomas only in female mice at the highest dose (>200-times human exposure) is not considered relevant for humans.
Danish: En signifikant højere forekomst af maligne lymfomer udelukkende hos hunmus ved den højeste dosis (> 200 gange human eksponering) betragtes ikke som relevant for mennesker.
English: Before initiating empagliflozin, factors in the patient history that may predispose to ketoacidosis should be considered.
Danish: Inden empagliflozin-behandling påbegyndes, skal der tages højde for faktorer i patientens anamnese, som kan prædisponere for ketoacidose.
English: If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Danish: Hvis du er gravid, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge til råds, før du tager Glyxambi.
English: Empagliflozin does not inhibit P-gp at therapeutic doses.
Danish: Empagliflozin hæmmer ikke P-gp ved terapeutiske doser.
English: The intra-subject and inter-subject coefficients of variation for linagliptin AUC were small (12.6 % and 28.5 %, respectively).
Danish: De intra-individuelle og inter-individuelle variationskoefficienter for linagliptins AUC var lave (henholdsvis 12,6 % og 28,5 %).
English: The inter subject and residual variabilities for empagliflozin oral clearance were 39.1 % and 35.8 %, respectively.
Danish: Den inter-individuelle og intra-individuelle variabilitet for oral clearance af empagliflozin var henholdsvis 39,1 % og 35,8 %.
English: Copovidone (K-value nominally 28) Crospovidone (Type B) Talc
Danish: Copovidon (K-værdi nominelt 28) Crospovidon (type B)
English: • if you have or have had a disease of the pancreas.
Danish: • hvis du har eller tidligere har haft sygdom i bugspytkirtlen.
English: CV Death N (%)
Danish: CV-død, N (%)
English: Use of dipeptidyl peptidase-4 (DPP-4) inhibitors has been associated with a risk of developing acute pancreatitis.
Danish: Brug af dipeptidyl-peptidase-4 (DPP-4)-hæmmere er forbundet med risiko for udvikling af akut pankreatitis.
English: If you have type 2 diabetes, your pancreas may not make enough insulin to control the level of glucose in your blood, and your body is unable to use its own insulin effectively.
Danish: Hvis du har type 2-diabetes, danner din bugspytkirtel ikke insulin nok til at kontrollere dit blodsukker, og kroppen kan ikke udnytte det dannede insulin effektivt.
English: There is very little experience in patients aged 75 years or older.
Danish: Der er meget begrænset erfaring fra patienter på 75 år og derover.
English: Titanium dioxide (E171) Macrogol 6000
Danish: Titandioxid (E171) Macrogol 6000
English: In the event of an overdose, it is reasonable to employ the usual supportive measures, e.g., remove unabsorbed material from the gastrointestinal tract, employ clinical monitoring and institute clinical measures as required.
Danish: I tilfælde af en overdosis er det hensigtsmæssigt at benytte de sædvanlige understøttende foranstaltninger, f.eks. at fjerne ikke-absorberet materiale fra mave-tarm-kanalen, anvende klinisk monitorering og om nødvendigt iværksætte kliniske foranstaltninger.
English: HbA1c ( %) - 24 weeks
Danish: HbA1c (%) - 24 uger
English: see section 4.4 see subsection below for additional information
Danish: Se delpunktet nedenunder for yderligere oplysninger
English: Common Common Not known
Danish: Almindelig Almindelig Ikke kendt
English: Body mass index
Danish: Body Mass Index (BMI)
English: There is no experience with doses above 800 mg in humans.
Danish: Der er ingen erfaring med doser over 800 mg hos mennesker.
English: The amount of glucose removed by the kidney through this glucuretic mechanism is dependent upon the blood glucose concentration and GFR.
Danish: Mængden af glucose, der fjernes af nyrerne gennem denne glukuretiske mekanisme, afhænger af koncentrationen af glucose i blodet og GFR.
English: Insulin and sulphonylureas may increase the risk of hypoglycaemia.
Danish: Insulin og sulfonylurinstoffer kan øge risikoen for hypoglykæmi.
English: If you have symptoms of low blood sugar, eat glucose tablets, a high sugar snack or drink fruit juice.
Danish: Hvis du får tegn på for lavt blodsukker, skal du spise glukose (druesukker), et sukkerrigt mellemmåltid eller drikke frugtjuice.
English: However, temporary interruption of Glyxambi should be considered in patients with complicated urinary tract infections.
Danish: Midlertidig afbrydelse af Glyxambi skal dog overvejes hos patienter med komplicerede urinvejsinfektioner.
English: Insulin and sulphonylureas
Danish: Insulin og sulfonylurinstoffer
English: Empagliflozin is a reversible, highly potent (IC50 of 1.3 nmol) and selective competitive inhibitor of SGLT2.
Danish: Empagliflozin er en reversibel, yderst potent (IC50 1,3 nmol) og selektiv kompetitiv hæmmer af SGLT2.
English: The effects of Glyxambi on pregnancy, breast-feeding and fertility are not known.
Danish: Glyxambis indvirkning på graviditet, amning og fertilitet er ikke kendt.
English: Contact your doctor immediately if you notice any of the following side effects:
Danish: Kontakt din læge med det samme, hvis du bemærker en eller flere af følgende bivirkninger:
English: Animal studies with empagliflozin have shown adverse effects on postnatal development (see section 5.3).
Danish: Dyrestudier med empagliflozin har påvist negative virkninger på den postnatale udvikling (se pkt.
English: It is responsible, as the predominant transporter, for the reabsorption of glucose from the glomerular filtrate back into the circulation.
Danish: Det er, som det dominerende transportprotein, ansvarligt for reabsorption af glucose fra glomerulusfiltratet tilbage til cirkulationen.
English: Based on in vitro studies, empagliflozin is considered unlikely to cause interactions with medicinal products that are P-gp substrates.
Danish: På grundlag af in vitro-studier anses det ikke for sandsynligt, at empagliflozin interagerer med lægemidler, der er P-gp-substrater.
English: No major metabolites of empagliflozin were detected in human plasma and the most abundant metabolites were three glucuronide conjugates (2-, 3-, and 6-O-glucuronide).
Danish: Der blev ikke påvist nogen hovedmetabolitter af empagliflozin i humant plasma, og de væsentligste metabolitter var tre glukuronidkonjugater (2-, 3- og 6-O-glukuronid).
English: Based on the population pharmacokinetic analysis, the apparent terminal elimination half life of empagliflozin was estimated to be 12.4 hours and apparent oral clearance was 10.6 L/hour.
Danish: Baseret på den farmakokinetiske populationsanalyse blev den tilsyneladende terminale eliminationshalveringstid anslået til 12,4 timer, og den tilsyneladende orale clearance var 10,6 l/time.
English: • Swallow the tablet whole with water.
Danish: • Synk tabletten hel med vand.
English: There are no data from the use of empagliflozin and linagliptin in pregnant women.
Danish: Der er ingen data fra anvendelse af empagliflozin og linagliptin til gravide kvinder.
English: In a clinical trial with empagliflozin, haematocrit values returned towards baseline values after a follow-up period of 30 days after treatment stop.
Danish: I et klinisk studie med empagliflozin vendte hæmatokritværdierne tilbage mod baseline-værdien efter en opfølgningsperiode på 30 dage efter behandlingsophør.
English: Do not drive or use any tools or machines, if you experience any of these symptoms while taking Glyxambi.
Danish: Du må ikke køre motorkøretøj eller betjene maskiner, hvis du får et eller flere af disse symptomer, mens du tager Glyxambi.
English: • to improve glycaemic control when metformin and/or sulphonylurea (SU) and one of the monocomponents of Glyxambi do not provide adequate glycaemic control
Danish: • for at forbedre den glykæmiske kontrol, når metformin og/eller sulfonylurinstof (SU) og et af enkeltstofferne i Glyxambi ikke giver tilstrækkelig glykæmisk kontrol
English: • straining or pain when emptying the bladder
Danish: • anstrengelse eller smerte ved tømning af blæren
English: Seen rarely • sore in the mouth
Danish: Sjældne • sår i munden
English: It is important that you continue with your diet and exercise plan as recommended by your doctor, pharmacist or nurse.
Danish: Det er vigtigt, at du fortsætter med den diæt- og motionsplan, som din læge, apotekspersonalet eller sundhedspersonalet har anbefalet.
English: Glyxambi tablets are for oral use and can be taken with or without a meal at any time of the day at regular intervals.
Danish: Glyxambi er til oral anvendelse og kan tages med eller uden mad på et vilkårligt tidspunkt af dagen med regelmæssigt interval.
English: Oral 2-year carcinogenicity studies in rats and mice revealed no evidence of carcinogenicity in rats or male mice.
Danish: 2-årige orale karcinogenicitetsstudier hos rotter og mus viste ikke nogen evidens for karcinogenicitet hos rotter eller hanmus.
English: The majority of drug-related radioactivity recovered in faeces was unchanged parent drug and approximately half of drug related radioactivity excreted in urine was unchanged parent drug.
Danish: Hovedparten af den lægemiddelrelaterede radioaktivitet, der blev genfundet i fæces, var uomdannet lægemiddelstof, og ca. halvdelen af den lægemiddelrelaterede radioaktivitet, der blev genfundet i urin, var uomdannet lægemiddelstof.
English: Empagliflozin is a substrate of P-glycoprotein (P-gp) and breast cancer resistance protein (BCRP).
Danish: Empagliflozin er substrat for P-glykoprotein (P-gp) og brystcancer-resistent protein (BCRP).
English: SGLT2 prevents glucose from being excreted in urine by absorbing glucose back into the bloodstream as blood is being filtered in the kidneys.
Danish: SGLT2 forhindrer, at glukose bliver udskilt i urinen ved at absorbere glukose tilbage til blodbanen, når blodet bliver filtreret i nyrerne.
English: C]-empagliflozin solution to healthy volunteers, the red blood cell partitioning was approximately 37 % and plasma protein binding was
Danish: C]-empagliflozinopløsning til raske frivillige var fordelingen til røde blodceller ca. 37 %, og plasmaproteinbindingen var 86 %.
English: Treatment with Glyxambi should not be started in patients above the age of 75.
Danish: Behandling med Glyxambi bør ikke påbegyndes hos patienter over 75 år.
English: The glucosuria observed with empagliflozin is accompanied by diuresis which may contribute to sustained and moderate reduction of blood pressure.
Danish: Den glukosuri, der er observeret med empagliflozin, er ledsaget af diurese, som kan bidrage til en vedvarende moderat blodtryksreduktion.