FrancophonIA/ELRC3.0 huggingface dataset:
English: DuoCover was expected to be used in adult patients already taking clopidogrel and acetylsalicylic acid as separate tablets.
Danish: DuoCover forventedes anvendt til voksne patienter, som allerede tager clopidogrel- og acetylsalicylsyretabletter hver for sig.
English: ‘bioequivalence' studies to establish whether the combined tablet was absorbed in the body in the same way as the two medicines given separately.
Danish: Til støtte for ansøgningen om markedsføringstilladelse for DuoCover gennemførte virksomheden ”bioækvivalensundersøgelser” for at fastslå, om den kombinerede tablet blev optaget i kroppen på samme måde som de to lægemidler givet hver for sig.
English: Steglujan should be taken orally once daily in the morning, with or without food.
Danish: Steglujan skal tages oralt en gang dagligt om morgenen med eller uden mad.
English: Not known (frequency cannot be estimated from the available data)
Danish: Ikke kendt (hyppighed kan ikke vurderes ud fra tilgængelige data)
English: It also lowers the amount of sugar made by your body.
Danish: Det sænker også mængden af sukker, som kroppen producerer.
English: Talk with your doctor about the best way to feed your baby if you take Steglujan.
Danish: Tal med lægen om, hvordan du bedst giver dit barn mad, hvis du tager Steglujan.
English: Onset of these reactions occurred within the first 3 months after initiation of treatment, with some reports occurring after the first dose.
Danish: Disse reaktioner startede inden for de første 3 måneder efter initiering af behandlingen, hvor enkelte rapporter forekom efter første dosis.
English: • You need to keep following your food and exercise plan while taking Steglujan.
Danish: • Du skal fortsætte med at følge din kost- og motionsplan, mens du tager Steglujan.
English: • if you are taking digoxin (a medicine used to treat irregular heart beat and other heart problems).
Danish: • hvis du tager digoxin (et lægemiddel, der anvendes til at behandle uregelmæssig hjerterytme og andre hjerteproblemer).
English: There is limited experience with Steglujan in patients ≥ 75 years of age.
Danish: Der er begrænset erfaring med Steglujan hos patienter ≥ 75 år.
English: It is not known if Steglujan can harm your unborn baby.
Danish: Det er ukendt, om Steglujan kan skade dit ufødte barn.
English: • The dose of Steglujan that you take will depend on your condition and the amount of ertugliflozin and sitagliptin needed to control your blood sugar.
Danish: • Hvilken dosis af Steglujan, du skal tage, afhænger af din tilstand og af, hvilken mængde ertugliflozin og sitagliptin, du har behov for til at kontrollere dit blodsukker.
English: • Steglujan can be used alone or with some other medicines that lower blood sugar.
Danish: • Steglujan kan anvendes alene eller sammen med visse andre lægemidler, der sænker blodsukkeret.
English: • The recommended dose of Steglujan is one tablet once a day.
Danish: • Den anbefalede dosis af Steglujan er 1 tablet en gang dagligt.
English: There is no information regarding the presence of Steglujan or its individual components in human milk, the effects on the breast-fed infant, or the effects on milk production.
Danish: Der foreligger ingen oplysninger om tilstedeværelse af Steglujan eller dets enkeltstoffer i human mælk, virkningen på det ammede barn eller virkningen på mælkeproduktionen.
English: Frequency categories are defined according to the following convention: 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), not known (cannot be estimated from the available data).
Danish: Hyppighedskategorierne 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: Because of the high safety margin (19-fold at this no-effect level), these neoplastic changes are not considered relevant for the situation in humans.
Danish: På grund af den høje sikkerhedsmargin (19 gange på dette niveau for ingen observeret effekt), anses disse neoplastiske ændringer ikke som relevante for situationen hos mennesker.
English: Approximately 79% of sitagliptin is excreted unchanged in the urine.
Danish: Ca. 79% af sitagliptin udskilles uændret i urinen.
English: You should not take this medicine during pregnancy.
Danish: Du må ikke tage dette lægemiddel under graviditet.
English: Patients should not take two doses of Steglujan on the same day.
Danish: Patienten må ikke tage en dobbeltdosis Steglujan på samme dag.
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: p< 0.001 compared to placebo.
Danish: p < 0,001 sammenlignet med placebo.
English: Hispanic or Latino patients comprised 15.6% to 36.1% of the population.
Danish: Latinamerikanske patienter udgjorde 15,6 - 36,1% af populationen.
English: The effects on kidney and bone did not fully reverse after the 1 month recovery period.
Danish: Virkningerne på nyrer og knogler reverseredes ikke helt efter den 1 måned lange restitutionsperiode.
English: Hospitalisation for unstable angina
Danish: Hospitalsindlæggelse pga. ustabil angina
English: Other potential causes for the event should be assessed, and alternative treatment for diabetes initiated.
Danish: Det skal vurderes, om der er andre potentielle årsager til hændelsen, og alternativ diabetesbehandling skal initieres.
English: Warnings and precautions Talk to your doctor, pharmacist, or nurse before and while taking Steglujan if you:
Danish: Advarsler og forsigtighedsregler Kontakt lægen, apotekspersonalet eller sygeplejersken, før og mens du tager Steglujan, hvis du:
English: What you need to know before you take Steglujan 3.
Danish: Det skal du vide, før du begynder at tage Steglujan 3.
English: Treatment with Steglujan may be restarted when the ketone values are normal and the patient's condition has stabilised.
Danish: Behandlingen med Steglujan kan genoptages, når ketonstofværdierne er normale, og patientens tilstand er stabiliseret.
English: Your doctor may decide to temporarily or permanently stop your treatment with Steglujan.
Danish: Lægen kan beslutte at stoppe din behandling med Steglujan midlertidigt eller permanent.
English: • if you are allergic to ertugliflozin or sitagliptin or any of the other ingredients of this medicine
Danish: • hvis du er allergisk over for ertugliflozin eller sitagliptin eller et af de øvrige indholdsstoffer i
English: Alternative methods should be used to monitor glycaemic control.
Danish: Der skal anvendes alternative metoder til at monitorere glykæmisk kontrol.
English: • have or have had gallstones, alcohol dependence or very high levels of triglycerides (a form of fat) in your blood.
Danish: • har eller har haft galdesten, alkoholafhængighed eller et meget højt indhold af triglycerider (en fedtstoftype) i blodet.
English: *Incidence rate per 100 patient-years is calculated as 100 × (total number of patients with ≥ 1 event during eligible exposure period per total patient-years of follow-up).
Danish: * Incidensrate pr. 100 patientår er beregnet som 100 × (samlet antal patienter med ≥ 1 hændelse i løbet af en egnet eksponeringsperiode pr. samlet antal patientår med opfølgning).
English: Ertugliflozin and sitagliptin are present in the milk of lactating rats.
Danish: Ertugliflozin og sitagliptin er til stede i mælk hos diegivende rotter.
English: • have or have had a disease of the pancreas (such as pancreatitis).
Danish: • har eller har haft en sygdom i bugspytkirtlen (f.eks. pankreatitis).
English: • kidney problems (sometimes requiring dialysis)
Danish: • nyreproblemer (som kan kræve dialyse)
English: • when metformin and/or a sulphonylurea (SU) and one of the monocomponents of Steglujan do not provide adequate glycaemic control.
Danish: • når metformin og/eller et sulfonylurinstof (SU) og et af enkeltstofferne i Steglujan ikke giver tilstrækkelig glykæmisk kontrol.
English: Table 5: Rates of composite cardiovascular outcomes and key secondary outcomes
Danish: Tabel 5: Hyppighed af sammensatte kardiovaskulære endepunkter og vigtige sekundære endepunkter
English: Your doctor may prescribe a medicine to treat your allergic reaction and a different medicine for your diabetes.
Danish: Lægen vil muligvis udskrive et lægemiddel til behandling af den allergiske reaktion og et andet lægemiddel mod din diabetes.
English: Experience in New York Heart Association (NYHA) class I-II is limited, and there is no experience in clinical studies with Steglujan 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 Steglujan i NYHA-klasse III-IV.
English: • Steglujan can be used instead of taking both ertugliflozin and sitagliptin as separate tablets.
Danish: • Steglujan kan anvendes i stedet for at tage både ertugliflozin og sitagliptin som separate tabletter.
English: Exfoliative skin conditions including Stevens-Johnson syndrome a,
Danish: Eksfoliative hudsygdomme herunder Stevens-Johnsons syndrom a,
English: Ertugliflozin is not expected to be effective in these patients.
Danish: Ertugliflozin forventes ikke at virke hos disse patienter.
English: • in patients already being treated with the combination of ertugliflozin and sitagliptin as separate tablets.
Danish: • hos patienter, der allerede behandles med kombinationen af ertugliflozin og sitagliptin som separate tabletter.
English: • Sitagliptin helps to increase the levels of insulin produced after a meal.
Danish: • Sitagliptin er med til at øge mængden af insulin, der frigives efter et måltid.
English: Before initiating Steglujan, volume status should be assessed and corrected if indicated.
Danish: Inden initiering af behandling med Steglujan skal volumenstatus vurderes og afhjælpes, hvis påkrævet.
English: The mean age of the patients across these 3 studies ranged from 55.1 to 59.1 years (range 21 years to 85 years).
Danish: Gennemsnitsalderen for patienterne i de 3 studier varierede fra 55,1 til 59,1 år (interval fra 21 år til 85 år).
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: Sitagliptin is secreted in considerable amounts into the milk of lactating rats (milk/plasma ratio: 4:1).
Danish: Sitagliptin udskilles i betydelige mængder i modermælken hos diegivende rotter (mælk/plasma-ratio: 4:1).
English: Hypersensitivity reactions including anaphylactic responses*
Danish: Overfølsomhedsreaktioner herunder anafylaktiske reaktioner*
English: It is not known if this medicine passes into breast milk.
Danish: Det er ukendt, om dette lægemiddel udskilles i modermælken.
English: Do not use this medicine if the packaging is damaged or shows signs of tampering.
Danish: Tag ikke lægemidlet, hvis pakningen er beskadiget eller viser tegn på, at den har været åbnet.
English: The level of digoxin in your blood may need to be checked if you are taking it with Steglujan.
Danish: Det kan være nødvendigt at kontrollere indholdet af digoxin i blodet, hvis du tager det sammen med Steglujan.
English: For patients treated with ertugliflozin who are being switched to Steglujan, the dose of ertugliflozin can be maintained.
Danish: Hos patienter, som behandles med ertugliflozin, og som skiftes over til Steglujan, kan dosis af ertugliflozin opretholdes.
English: • Severe and persistent pain in the abdomen (stomach area) which might reach through to your back with or without nausea and vomiting, as these could be signs of an inflamed pancreas (pancreatitis).
Danish: • Svære og vedvarende smerter i maven, som kan stråle ud i ryggen, med eller uden kvalme og opkastning, da det kan være tegn på betændelse i bugspytkirtlen (pankreatitis).
English: Rare • reduced number of platelets
Danish: Sjælden • nedsat antal blodplader
English: See “Description of selected adverse reactions” for frequencies and see section 4.4.
Danish: Se “Beskrivelse af udvalgte bivirkninger” for hyppigheder og se pkt.
English: However, dizziness and drowsiness have been reported with sitagliptin, which may affect your ability to drive or use machines.
Danish: Svimmelhed og døsighed er dog indberettet i forbindelse med sitagliptin, hvilket kan påvirke din evne til at køre bil eller betjene maskiner.
English: Across the 3 studies, 16.2% to 29.9% of patients were ≥ 65 years of age and 2.3% to 2.8% were ≥ 75 years of age.
Danish: I de 3 studier var 16,2% til 29,9% af patienterne ≥ 65 år, og 2,3% til 2,8% var ≥ 75 år.
English: • might be at risk of dehydration (for example, if you are taking medicines that increase urine production [diuretics] or lower blood pressure or if you are over 65 years old).
Danish: • har risiko for dehydrering (f.eks. hvis du tager medicin, der øger urinproduktionen (vanddrivende medicin [diuretika]) eller sænker blodtrykket, eller hvis du er over 65 år).
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 den humane risiko.
English: • if you are taking other medicines that lower the amount of sugar in your blood, such as insulin or medicines that increase insulin release from the pancreas.
Danish: • hvis du tager anden medicin, der sænker mængden af sukker i blodet, f.eks. insulin eller lægemidler, der øger insulinfrigivelsen fra bugspytkirtlen.
English: In vitro transport studies showed that sitagliptin is a substrate for P-gp and OAT3.
Danish: In vitro-transportstudier har vist, at sitagliptin er et substrat for P-gp og OAT3.
English: No drug interactions studies have been performed with Steglujan and other medicinal products; however, such studies have been conducted with the individual active substances.
Danish: Der er ikke udført lægemiddelinteraktionsstudier med Steglujan og andre lægemidler; sådanne studier er dog udført med de enkelte aktive stoffer.
English: Steglujan is available in Alu/PVC/PA/Alu blisters.
Danish: Steglujan fås i Alu/PVC/PA/Alu-blistre.
English: The incidence and type of adverse reactions in these three studies were similar to the adverse reactions seen with ertugliflozin and are described below in Table 1.
Danish: Incidensen og typen af bivirkninger i disse tre studier var sammenlignelige med de bivirkninger, der er set med ertugliflozin, og er beskrevet nedenfor i tabel 1.
English: What Steglujan is Steglujan contains two active substances, ertugliflozin and sitagliptin.
Danish: Hvad Steglujan er Steglujan indeholder to aktive stoffer, ertugliflozin og sitagliptin.
English: If you stop taking Steglujan
Danish: Hvis du holder op med at tage Steglujan
English: 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: Disse symptomer kan være tegn på “diabetisk ketoacidose” - en tilstand der kan opstå i forbindelse med diabetes som følge af forhøjet indhold af “ketonstoffer” i urin- eller blodtest.
English: Adverse reactions were identified through post-marketing surveillance.
Danish: Bivirkninger blev identificeret ved bivirkningsovervågning efter markedsføring.
English: • a sweet smell to your breath, a sweet or metallic taste in your mouth or a different odour to your urine or sweat
Danish: • en sødlig ånde, en sødlig eller metallisk smag i munden eller din urin eller sved lugter anderledes
English: Alu/PVC/PA/Alu blisters
Danish: Alu/PVC/PA/Alu-blistre
English: Elderly subjects (65 to 80 years) had approximately 19% higher plasma concentrations of sitagliptin compared to younger subjects.
Danish: Ældre patienter (65-80 år) havde ca. 19% højere sitagliptinplasmakoncentrationer sammenlignet med yngre patienter.
English: Coadministration of sitagliptin and metformin had an additive effect on active GLP-1 concentrations.
Danish: Samtidig administration af sitagliptin og metformin havde en additiv effekt på den aktive GLP-1-koncentration.
English: Do not drive or use any tools or machines if you feel dizzy while taking Steglujan.
Danish: Du må ikke køre bil eller betjene maskiner, hvis du føler dig svimmel, når du tager Steglujan.
English: If Fournier's gangrene is suspected, Steglujan should be discontinued and prompt treatment (including antibiotics and surgical debridement) should be instituted.
Danish: Hvis der er mistanke om Fourniers gangræn, bør Steglujan seponeres, og øjeblikkelig behandling (herunder antibiotika og kirurgisk debridement) bør iværksættes.
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 EUreferencedatoer (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: In patients with normal renal function, metabolism, including via CYP3A4, plays only a small role in the clearance of sitagliptin.
Danish: Hos patienter med normal nyrefunktion spiller metabolisering, inklusive metabolisering via CYP3A4, kun en lille rolle i sitagliptin-clearance.
English: The absolute oral bioavailability of ertugliflozin following administration of a 15-mg dose is approximately 100%.
Danish: Den absolutte orale biotilgængelighed af ertugliflozin efter administration af en 15 mg dosis er ca. 100%.
English: Analysis in the Intention-to-Treat Population
Danish: Analyse i intention to treat-populationen
English: C]sitagliptin oral dose, approximately 16% of the radioactivity was excreted as metabolites of sitagliptin.
Danish: C] sitagliptin-dosis udskiltes ca. 16% af radioaktiviteten som sitagliptin-metabolitter.
English: Therefore, Steglujan should not be used during pregnancy.
Danish: Derfor bør Steglujan ikke anvendes under graviditet.
English: Initial increases in mean creatinine and decreases in mean eGFR in patients treated with ertugliflozin were generally transient during continuous treatment.
Danish: Initiale stigninger i gennemsnitlig kreatinin og fald i gennemsnitlig eGFR hos patienter, der fik ertugliflozin, var generelt forbigående under kontinuerlig behandling.
English: Due to the mechanism of action of ertugliflozin, patients taking Steglujan will test positive for glucose in their urine.
Danish: På grund af ertugliflozins virkningsmekanisme vil patienter, som får Steglujan, teste positive for glucose i urinen.
English: The analysis of hospitalisation for heart failure was adjusted for a history of heart failure at baseline.
Danish: Analysen af hospitalsindlæggelser pga. hjertesvigt blev justeret for hjertesvigt i anamnesen ved baseline.
English: In vitro, sitagliptin did not inhibit OAT3 (IC50=160 M) or p-glycoprotein (up to 250 M) mediated transport at therapeutically relevant plasma concentrations.
Danish: In vitro hæmmede sitagliptin ikke OAT3 (IC50=160 M) eller p-glycoprotein (op til 250 M) medieret transport ved terapeutisk relevante plasmakoncentrationer.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Steglujan in all subsets of the paediatric population in the treatment of type 2 diabetes (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med Steglujan i alle undergrupper af den pædiatriske population ved behandling af type 2diabetes (se pkt.
English: MSD Italia S.r.l.
Danish: Italia MSD Italia S.r.l.
English: In vitro data suggest that sitagliptin does not inhibit or induce CYP450 isoenzymes.
Danish: In vitro-data tyder på, at sitagliptin hverken hæmmer eller inducerer CYP450-isoenzymer.
English: There were no additional adverse reactions identified in these three trials that included sitagliptin relative to the three placebocontrolled studies with ertugliflozin (see below).
Danish: Der blev ikke identificeret yderligere bivirkninger i disse tre studier, der omfattede sitagliptin, i forhold til de tre placebokontrollerede studier med ertugliflozin (se nedenfor).
English: However, ciclosporin, a P-gp inhibitor, did not reduce the renal clearance of sitagliptin.
Danish: Ciclosporin, en P-gp-hæmmer, reducerede dog ikke sitagliptins renale clearance.
English: If pancreatitis is suspected, Steglujan and other potentially suspect medicinal products should be discontinued; if acute pancreatitis is confirmed, Steglujan should not be restarted.
Danish: Hvis der er mistanke om pankreatitis, bør Steglujan og andre potentielt suspekte lægemidler seponeres, og hvis mistanken om akut pankreatitis bekræftes, må behandlingen med Steglujan ikke genoptages.
English: This decrease in exposure is not considered clinically relevant and therefore, no dose adjustment is recommended.
Danish: Denne reduktion i eksponering anses ikke for at være klinisk relevant, og dosisjustering anbefales derfor ikke.
English: Following administration of 0.25 mg digoxin concomitantly with 100 mg of sitagliptin daily for 10 days, the plasma AUC of digoxin was increased on average by 11% and the plasma Cmax on average by 18%.
Danish: Efter administration af 0,25 mg digoxin samtidig med 100 mg sitagliptin dagligt i 10 dage øgedes plasma-AUC for digoxin gennemsnitligt med 11% og plasma Cmax med gennemsnitligt 18%.
English: Use of dipeptidyl peptidase-4 (DPP-4) inhibitors has been associated with a risk of developing acute pancreatitis.
Danish: Brug af dipeptidylpeptidase 4 (DPP-4)-hæmmere er sat i forbindelse med en risiko for udvikling af akut pankreatitis.
English: p< 0.001 compared to placebo (based on adjusted odds ratio comparisons from a logistic regression model using multiple imputation for missing data values).
Danish: p < 0,001 sammenlignet med placebo (baseret på justerede odds ratio-sammenligninger fra en logistisk regressionsmodel med multipel imputation for manglende dataværdier).
English: The activity of GLP-1 and GIP is limited by the DPP-4 enzyme, which rapidly hydrolyses the incretin hormones to produce inactive products.
Danish: Aktiviteten af GLP-1 og GIP begrænses af DPP-4-enzymet, som hurtigt hydrolyserer inkretinhormonerne til inaktive produkter.
English: Ertugliflozin and Sitagliptin
Danish: Ertugliflozin og sitagliptin
English: Patients 65 years and older treated with ertugliflozin, had a higher incidence of adverse reactions related to volume depletion compared to younger patients.
Danish: Patienter i alderen 65 år og derover, som blev behandlet med ertugliflozin, havde en højere incidens af bivirkninger relateret til volumendepletering sammenlignet med yngre patienter.
English: Only 1.5% of the administered dose was excreted as unchanged ertugliflozin in urine and 34% as unchanged ertugliflozin in faeces, which is likely due to biliary excretion of glucuronide metabolites and subsequent hydrolysis to parent.
Danish: Kun 1,5% af den administrerede dosis blev udskilt som uomdannet ertugliflozin i urinen og 34% som uomdannet ertugliflozin i fæces, hvilket sandsynligvis skyldes biliær udskillelse af glukuronidmetabolitter og efterfølgende hydrolyse til moderstoffet.
English: C]-sitagliptin dose to healthy subjects, approximately 100% of the administered radioactivity was eliminated in faeces (13%) or urine (87%) within one week of dosing.
Danish: C] sitagliptin-dosis til raske forsøgspersoner elimineredes ca. 100% af den administrerede radioaktivitet i fæces (13%) eller urin (87%) inden for en uge efter dosering.