FrancophonIA/ELRC3.0 huggingface dataset:
English: The most commonly reported adverse reaction related to renal function was serum creatinine increases, the majority of which were transient and reversible (see section 4.8).
Danish: Den hyppigst rapporterede nyrefunktionsrelaterede bivirkning var stigning i serumkreatinin, hvor de fleste tilfælde var forbigående og reversible (se pkt.
English: This is an antibiotic used to treat infections such as tuberculosis.
Danish: - Rifampicin, der er et antibiotikum til behandling af infektioner såsom tuberkulose.
English: Protein binding was not altered in various disease states (e.g. renal or hepatic impairment).
Danish: Proteinbindingen blev ikke ændret ved forskellige sygdomstilstande (f.eks. nedsat nyre- eller leverfunktion).
English: Subjects at higher risk for hospitalisation for heart failure, irrespective of treatment assignment, could be identified by known risk factors for heart failure such as baseline history of heart failure or impaired renal function.
Danish: Forsøgspersoner med højere risiko for hospitalsindlæggelse pga. hjertesvigt kunne uanset tildeling af behandling identificeres ved kendte risikofaktorer for hjertesvigt såsom baseline-anamnese med hjertesvigt eller nedsat nyrefunktion.
English: Remember to take other medicine(s) as your doctor has told you.
Danish: Husk at tage din anden medicin, som lægen har anvist.
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 DKA, omfatter patienter med lav restfunktion af betaceller (f.eks. type 2-diabetespatienter med lavt C-peptid, latent autoimmun diabetes hos voksne (LADA) eller patienter med pankreatitis i anamnesen), patienter med tilstande, der medfører lav fødeindtagelse eller alvorlig dehydrering, patienter, hvis insulindosis er reduceret, samt patienter med øget behov for insulin på grund af akut sygdom, operation eller alkoholmisbrug.
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 i tilfælde af ikke-specifikke symptomer såsom kvalme, opkastning, anoreksi, abdominalsmerter, udtalt tørst, vejrtrækningsbesvær, konfusion, usædvanlig træthed eller søvnighed.
English: See corresponding subsections below for events in the dapagliflozin programme.
Danish: Se de tilsvarende underafsnit nedenfor for bivirkninger i dapagliflozinprogrammet.
English: Approximately 70 g of glucose was excreted in the urine per day (corresponding to 280 kcal/day) at a dapagliflozin dose of 10 mg/day in subjects with type 2 diabetes mellitus for 12 weeks.
Danish: Der blev udskilt ca. 70 g glucose i urinen pr. dag (svarende til 280 kcal/dag) ved en dosis på 10 mg dapagliflozin dagligt i 12 uger hos forsøgspersoner med type 2-diabetes mellitus.
English: These medications did not alter the pharmacokinetics of dapagliflozin.
Danish: Disse lægemidler ændrede ikke farmakokinetikken af dapagliflozin.
English: It is unknown whether saxagliptin and dapagliflozin and/or its metabolites are excreted in human milk.
Danish: Det er ukendt, om saxagliptin og dapagliflozin og/eller deres metabolitter udskilles i human mælk.
English: Dapagliflozin and related metabolites are primarily eliminated via urinary excretion with less than 2 % as unchanged dapagliflozin.
Danish: Dapagliflozin og relaterede metabolitter elimineres primært via udskillelse i urinen med mindre end 2 % som uomdannet dapagliflozin.
English: No appreciable accumulation of either saxagliptin or its major metabolite was observed with repeated once-daily dosing at any dose level.
Danish: Der er ikke observeret betydelig akkumulering af hverken saxagliptin eller hovedmetabolitten ved gentagne en-gang-daglig-doseringer på noget dosisniveau.
English: However, subjects on saxagliptin with a history of heart failure or impaired renal function at baseline were not at an increased risk relative to placebo for the primary or secondary composite endpoints or all-cause mortality.
Danish: Forsøgspersoner i saxagliptingruppen, som havde hjertesvigt eller nedsat nyrefunktion i anamnesen ved baseline, havde imidlertid ikke en øget risiko i forhold til placebo for de primære ogsekundære sammensatte endepunkter eller totalmortalitet.
English: Drug interactions:
Danish: Lægemiddelinteraktioner:
English: - Necrotising fasciitis of the perineum or Fournier's gangrene, a serious soft tissue infection of the genitals or the area between the genitals and the anus.
Danish: - Nekrotiserende fasciitis i mellemkødet (Fourniers gangræn), en alvorlig bløddelsinfektion i kønsdelene eller området mellem kønsdelene og anus.
English: - Dehydration, (loss of too much fluid from your body), seen uncommonly (may affect up to 1 in 100 people).
Danish: - Dehydrering, (tab af for meget væske fra kroppen), ikke almindelig (kan forekomme hos op til 1 ud af 100 patienter).
English: Additionally, urinary tract infections were frequently reported in saxagliptin and dapagliflozin clinical programmes.
Danish: Derudover blev der hyppigt rapporteret om urinvejsinfektioner i de kliniske programmer for saxagliptin og dapagliflozin.
English: Monitoring of renal function
Danish: Monitorering af nyrefunktion
English: No episodes of major hypoglycaemia were reported, and no subject discontinued the study treatment due to hypoglycaemia.
Danish: Der blev ikke rapporteret nogen episoder med alvorlig hypoglykæmi, og ingen forsøgspersoner afbrød studiebehandlingen på grund af hypoglykæmi.
English: Limited data from clinical trials with dapagliflozin suggest that DKA occurs with common frequency when patients with type 1 diabetes are treated with SGLT2 inhibitors.
Danish: Begrænsede data fra kliniske studier med dapagliflozin tyder på, at DKA optræder med hyppigheden ”almindelig”, når patienter med type 1diabetes behandles med SGLT2-hæmmere.
English: Saxagliptin: Saxagliptin was rapidly absorbed after oral administration in the fasted state, with maximum plasma concentrations (Cmax) of saxagliptin and its major metabolite attained within 2 and 4 hours (Tmax), respectively.
Danish: Saxagliptin: Saxagliptin absorberes hurtigt efter oral administration ved faste, og maksimale plasmakoncentrationer (Cmax) af saxagliptin og hovedmetabolitten opnås inden for henholdsvis 2 og 4 timer (Tmax).
English: Saxagliptin was not teratogenic at any doses evaluated in rats or rabbits.
Danish: Saxagliptin var ikke teratogent hos rotter eller kaniner i nogen af de doser, som blev undersøgt.
English: Dapagliflozin may add to the diuretic effect of thiazide and loop diuretics and may increase the risk of dehydration and hypotension (see section 4.4).
Danish: Dapagliflozin kan øge den diuretiske virkning af thiazider og loop-diuretika, hvilket kan øge risikoen for dehydrering og hypotension (se pkt.
English: Dapagliflozin blocks reabsorption of filtered glucose from the S1 segment of the renal tubule, effectively lowering blood glucose in a glucose dependent and insulin-independent manner.
Danish: Dapagliflozin blokerer reabsorption af filtreret glucose fra S1-segmentet af de renale tubuli, hvilket effektivt sænker blodglucose på en glucoseafhængig og insulinuafhængig måde.
English: When considering the cases of tumours occurring in the different organ systems, the relative risk associated with dapagliflozin was above 1 for some tumours (bladder, prostate, breast) and below 1 for others (e.g. blood and lymphatic, ovary, renal tract), not resulting in an overall increased tumour risk associated with dapagliflozin.
Danish: Når tilfældene, der forekom i de forskellige organsystemer, blev vurderet, var den relative risiko associeret med dapagliflozin over 1 for nogle tumorer (blære, prostata, bryst) og under 1 for andre (fx blod og lymfesystemet, ovarier, urinveje), og resulterede ikke i en samlet øget tumorrisiko for dapagliflozin.
English: Baseline (mean)
Danish: Baseline (gennemsnit)
English: Stop taking Qtern and see a doctor or nurse straight away, if you notice any of the serious side effects above.
Danish: Stop med at tage Qtern og kontakt straks en læge eller sygeplejerske, hvis du får nogen af de alvorlige bivirkninger ovenfor.
English: Caution is warranted if Qtern is used in patients who have known risk factors for hospitalisation for heart failure, such as a history of heart failure or moderate to severe renal impairment.
Danish: Forsigtighed tilrådes, hvis Qtern anvendes til patienter, som har kendte risikofaktorer for hospitalsindlæggelse for hjertesvigt, såsom en anamnese med hjertesvigt eller moderat til svært nedsat nyrefunktion.
English: thirst
Danish: tørst
English: For patients receiving Qtern, in case of intercurrent conditions that may lead to volume depletion, careful monitoring of volume status (e.g. physical examination, blood pressure measurements, laboratory tests including haematocrit) and electrolytes is recommended.
Danish: Det anbefales, at patienter ved interkurrente lidelser, der kan medføre volumendepletering, monitoreres nøje for væskestatus (fx fysisk undersøgelse, blodtryksmålinger, laboratorieprøver inklusive hæmatokrit) og elektrolytter.
English: Adverse reactions were reported in ≥ 2 % of subjects with either mono-component and ≥ 1 % more than placebo, but not in the pooled analysis.
Danish: Bivirkningen blev rapporteret hos ≥ 2 % af forsøgspersonerne med enten det ene eller andet enkeltstof og ≥ 1 % højere end placebo, men ikke i den puljede analyse.
English: C-saxagliptin, 24 %, 36 %, and 75 % of the dose was excreted in the urine as saxagliptin, its active metabolite, and total radioactivity, respectively.
Danish: C-saxagliptin blev henholdsvis 24 %, 36 % og 75 % af dosis udskilt i urinen som saxagliptin, hovedmetabolit og total radioaktivitet.
English: - if you often get infections of the urinary tract or have a serious infection of the urinary tract, including urosepsis or pyelonephritis, which can cause fever and/or chills, burning sensation when passing water (urinating), blood in urine, pain in your back or side.
Danish: • hvis du ofte får infektioner i urinvejene, eller hvis du har en alvorlig urinvejsinfektion, herunder urosepsis eller pyelonefritis, som kan forårsage feber og/eller kuldegysninger, en brændende fornemmelse, når du lader vandet, blod i urinen eller smerter i ryggen eller siden.
English: The event should be assessed and alternative treatment for diabetes should be instituted (see section 4.8).
Danish: Bivirkningen skal evalueres og alternativ diabetesbehandling indledes (se pkt.
English: C, urticaria
Danish: pruritus C, urticaria
English: After an oral glucose load, this produced in a 2- to 3-fold increase in circulating levels glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP), decreased glucagon concentrations, and increased beta-cell responsiveness, resulting in higher insulin and C-peptide concentrations.
Danish: Efter en oral glucosebelastning resulterede dette i en 2-3 fold stigning i de cirkulerende niveauer af glucagonlignende peptid-1 (GLP-1) og glucoseafhængigt insulinotropt polypeptid (GIP), et fald i glucagonkoncentrationen og en øgning af beta-cellereaktionsevnen,
English: Do not use this medicine after the expiry date, which is stated on the blister and carton after ‘EXP'.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på blisterkort og pakning efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
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: Rare cases of diabetic ketoacidosis (DKA), including life-threatening and fatal cases, have been reported in patients treated with SGLT2 inhibitors, including dapagliflozin.
Danish: Der er rapporteret sjældne tilfælde af diabetisk ketoacidose (DKA), herunder livstruende og dødelige tilfælde, hos patienter, som blev behandlet med SGLT2-hæmmere, herunder dapagliflozin.
English: Although uncommon, if you see blood in your urine, tell your doctor immediately.
Danish: Hvis du ser blod i urinen, skal du straks fortælle det til lægen; dette er dog ikke almindeligt.
English: Use with medicinal products known to cause hypoglycaemia Both saxagliptin and dapagliflozin can individually increase the risk of hypoglycaemia when combined with an insulin secretagogue.
Danish: Anvendelse sammen med lægemidler kendt for at forårsage hypoglykæmi Både saxagliptin og dapagliflozin kan hver for sig øge risikoen for hypoglykæmi, når de kombineres med et insulinsekretionsfremmende middel.
English: D, oedema peripheral
Danish: D, perifert ødem
English: The steady-state 24-hour urinary glucose excretion was highly dependent on renal function and 85, 52, 18 and 11 g of glucose/day was excreted by subjects with type 2 diabetes mellitus and normal renal function or mild, moderate or severe renal impairment, respectively.
Danish: Udskillelsen af glucose i urinen over 24 timer ved steady state var stærkt afhængig af nyrefunktionen, og der blev udskilt 85, 52, 18 og 11 g glucose/dag af forsøgspersoner med type 2-diabetes mellitus og normal nyrefunktion eller henholdsvis let, moderat eller svært nedsat nyrefunktion.
English: These changes are not considered to be clinically meaningful.
Danish: Disse ændringer anses ikke for klinisk relevante.
English: During post-marketing experience with saxagliptin, including spontaneous reports and clinical trials, the following adverse reactions have been reported with the use of saxagliptin: serious hypersensitivity reactions, including anaphylactic reaction, anaphylactic shock, and angioedema.
Danish: Efter markedsføring af saxagliptin er følgende bivirkninger indberettet efter anvendelse af saxagliptin, herunder fra spontane rapporter og kliniske studier: alvorlige overfølsomhedsreaktioner, herunder anafylaktisk reaktion, anafylaktisk shock og angioødem.
English: The hazard ratio comparing dapagliflozin to comparator was 0.79 (95 % CI: 0.58, 1.07), indicating that in this analysis dapagliflozin is not associated with an increase in cardiovascular risk in patients with type 2 diabetes mellitus.
Danish: Hazard ratio for sammenligning af dapagliflozin med komparator var 0,79 (95 % CI: 0,58-1,07), hvilket indikerer, at dapagliflozin i denne analyse ikke er forbundet med en øget kardiovaskulær risiko hos patienter med type 2-diabetes mellitus.
English: Qtern combines saxagliptin and dapagliflozin with complementary mechanisms of action to improve glycaemic control.
Danish: Qtern kombinerer saxagliptin og dapagliflozin med komplementære virkningsmekanismer for at forbedre den glykæmiske kontrol.
English: Talk to your doctor if you would like to or are breast-feeding before taking this medicine.
Danish: Tal med lægen, hvis du planlægger at amme eller ammer, før du tager denne medicin.
English: Qtern 5 mg/10 mg tablets are available in aluminium blisters in pack sizes of 14, 28, or 98 film-coated tablets in calendar blisters and 30 film-coated tablets in blister.
Danish: Qtern 5 mg/10 mg tabletter fås i aluminiumblistere i pakningsstørrelser på 14, 28 eller 98 filmovertrukne tabletter i kalenderblistere og 30 filmovertrukne tabletter i blister.
English: These are signs of dehydration: - very dry or sticky mouth, feeling very thirsty - feeling very sleepy or tired - passing little or no water (urine) - fast heart beat.
Danish: Dette er tegn på dehydrering: - meget tør eller klæbrig mund, udpræget tørst - udpræget søvnighed eller træthedsfølelse - meget lille eller ingen vandladning - hurtig hjerterytme (puls).
English: Animal studies have shown excretion of saxagliptin and/or metabolite in milk.
Danish: Dyrestudier har vist, at saxagliptin og/eller dens metabolit udskilles i mælk.
English: - If it is more than 12 hours since you should have taken your dose, skip the missed dose.
Danish: - Hvis det er mere end 12 timer siden, du skulle have taget din dosis, skal du springe den glemte dosis over.
English: Urinary tract infection vulvovaginitis, balanitis and related genital infection gastroenteritis
Danish: Urinvejsinfektion vulvovaginitis, balanitis og relaterede genitale infektioner gastroenteritis
English: Dapagliflozin is a highly potent (Ki: 0.55 nM), selective and reversible inhibitor of sodium-glucose co-transporter 2 (SGLT2).
Danish: Dapagliflozin er en meget potent (Ki: 0.55 nM) selektiv og reversibel hæmmer af natrium-glucose co-transporter 2 (SGLT2).
English: The intra-subject coefficients of variation for saxagliptin Cmax and AUC were less than
Danish: Den intraindividuelle variationskoefficient for saxagliptin Cmax og AUC var mindre end 12 %.
English: Actions of both medicinal products are regulated by the plasma glucose level.
Danish: Virkningen af begge lægemidler reguleres af plamaglucose.
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: Risikoen for at udvikle diabetisk ketoacidose kan være øget ved længerevarende faste, overdreven alkoholindtagelse, væskemangel (dehydrering), pludselig nedsættelse af insulindosis eller øget behov for insulin på grund af større operationer eller alvorlig sygdom.
English: Dapagliflozin: The metabolism of dapagliflozin is primarily via glucuronide conjugation mediated by UDP glucuronosyltransferase 1A9 (UGT1A9).
Danish: Dapagliflozin: Dapagliflozins metabolisme foregår primært via glukuronidkonjugering medieret af UDP-glukuronosyltransferase-1A9 (UGT1A9).
English: The pharmacokinetics of dapagliflozin, and saxagliptin and its major metabolite were similar in healthy subjects and in patients with type 2 diabetes.
Danish: Farmakokinetikken for dapagliflozin og for saxagliptin og dets hovedmetabolit var sammenlignelig hos raske forsøgspersoner og hos patienter med type 2-diabetes.
English: There have been post-marketing reports of serious urinary tract infections including urosepsis and pyelonephritis requiring hospitalisation in patients receiving dapagliflozin and other SGLT2 inhibitors.
Danish: Efter markedsføring har der været rapporter om alvorlige urinvejsinfektioner, herunder urosepsis og pyelonefritis, som krævede hospitalsindlæggelse, hos patienter, der fik dapagliflozin og andre SGLT2-hæmmere.
English: Rash has been seen with both saxagliptin and dapagliflozin when given separately (see section 4).
Danish: Udslæt er set både ved saxagliptin og dapagliflozin, når de gives hver for sig (se punkt 4).
English: Dapagliflozin: The mean plasma terminal half-life (t1/2) for dapagliflozin was 12.9 hours following a single oral dose of dapagliflozin 10 mg to healthy subjects.
Danish: Dapagliflozin: Den gennemsnitlige terminale halveringstid i plasma (t1/2) for dapagliflozin var 12,9 timer efter en enkelt oral dosis af dapagliflozin 10 mg til raske forsøgspersoner.
English: Saxagliptin/dapagliflozin combination: Of the 1169 subjects treated in the pooled safety data from the 3 clinical trials, 1007 subjects (86.1 %) were aged < 65 years, 162 subjects (13.9 %) were aged ≥ 65 years, and 9 subjects (0.8 %) were aged ≥ 75 years.
Danish: Saxagliptin/dapagliflozin-kombination: Af de 1.169 forsøgspersoner, som indgik i de puljede sikkerhedsdata fra de 3 kliniske studier, var 1.007 forsøgspersoner (86,1 %) < 65 år, 162 forsøgspersoner (13,9 %) var ≥ 65 år, og 9 forsøgspersoner (0,8 %) var ≥ 75 år.
English: The effect on offspring body weights were noted until postnatal day 92 and 120 in females and males, respectively.
Danish: Virkningen på afkommets legemsvægt blev observeret indtil dag 92 og 120 postnatalt hos henholdsvis hun- og hanrotter.
English: The majority of the genital infection adverse events were reported in females (84 % of subjects with a genital infection), were mild or moderate in intensity, of single occurrence, and most patients continued on therapy.
Danish: De fleste af bivirkningerne med genital infektion blev rapporteret hos kvinder (84 % af forsøgspersonerne med genital infektion); de var lette eller moderate i sværhedsgrad, forekom som enkeltstående tilfælde, og de fleste patienter fortsatte behandlingen.
English: You should call your doctor, pharmacist or nurse immediately if you experience any of these symptoms.
Danish: Du skal straks kontakte lægen, apotekspersonalet eller sundhedspersonalet, hvis du får nogen af disse symptomer.
English: The no effect level (NOEL) for the lesions is 1 and 2 times the human exposure of saxagliptin and the major metabolite respectively, at the recommended human dose (RHD) of 5 mg/day.
Danish: Nul-effekts-dosis (NOEL) for læsionerne er 1 og 2 gange den humane eksponering af henholdsvis saxagliptin og hovedmetabolitten ved den anbefalede humane dosis (RHD) på 5 mg/dag.
English: Vulvovaginitis, balanitis and related genital infections Saxagliptin/dapagliflozin combination: The reported adverse events of vulvovaginitis, balanitis and related genital infections from pooled safety analysis were reflective of the safety profile of dapagliflozin.
Danish: Vulvovaginitis, balanitis og relaterede genitale infektioner Saxagliptin/dapagliflozin-kombination: De rapporterede tilfælde af vulvovaginitis, balanitis og relaterede genitale infektioner fra den puljede sikkerhedsanalyse afspejlede sikkerhedsprofilen for dapagliflozin.
English: Saxagliptin: The mean plasma terminal half-life (t1/2) values for saxagliptin and its major metabolite are 2.5 hours and 3.1 hours respectively, and the mean t1/2 value for plasma DPP-4 inhibition was 26.9 hours.
Danish: Saxagliptin: De gennemsnitlige terminale plasmahalveringstider (t1/2) for saxagliptin og dets hovedmetabolit er henholdsvis 2,5 timer og 3,1 timer, og gennemsnitlig t1/2 for plasma-DPP-4hæmning er 26,9 timer.
English: Urine laboratory assessments Due to its mechanism of action, patients taking Qtern will test positive for glucose in their urine.
Danish: På grund af Qterns virkningsmekanisme vil patienterne få et positivt analyseresultat for glucose i urinen.
English: Studies in animals with saxagliptin have shown reproductive toxicity at high doses (see section 5.3).
Danish: Dyrestudier med saxagliptin har påvist reproduktionstoksicitet ved høje doser (se pkt.
English: Dapagliflozin: Dapagliflozin is extensively metabolised, primarily to yield dapagliflozin 3-O-glucuronide, which is an inactive metabolite.
Danish: Dapagliflozin: Dapagliflozin metaboliseres i udstrakt grad, primært til dapagliflozin-3-O-glukuronid, som er en inaktiv metabolit.
English: Based on very limited experience in patients 75 years and older, initiation of Qtern therapy is not recommended in this population (see sections 4.4 and 5.2).
Danish: Da der kun er meget begrænset erfaring med behandling af patienter over 75 år, kan initiering af behandling med Qtern ikke anbefales hos denne aldersgruppe (se pkt.
English: Excipient with known effect Each tablet contains 40 mg of lactose (as anhydrous).
Danish: Hjælpestof, som behandleren skal være opmærksom på Hver tablet indeholder 40 mg lactose (som vandfri lactose).
English: The degree of renal impairment did not affect the Cmax of saxagliptin or its major metabolite.
Danish: Graden af nyrefunktionsnedsættelse havde ingen indvirkning på Cmax for saxagliptin eller hovedmetabolitten.
English: Dapagliflozin: Dapagliflozin exposure was found to decrease with increased weight.
Danish: Dapagliflozin: Det er vist, at eksponeringen for dapagliflozin falder med øget vægt.