FrancophonIA/ELRC3.0 huggingface dataset:
English: Frequency categories were defined according to very common (≥ 1/10), common (≥ 1/100 to ˂ 1/10), uncommon (≥ 1/1000 to ˂ 1/100), rare ( 1/10,000 to < 1/1000) 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 (≥ 1/1000 til ˂ 1/100), sjælden ( 1/10.000 til < 1/1000) og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: In the event of an overdose, appropriate supportive treatment should be initiated as dictated by the patient's clinical status.
Danish: I tilfælde af en overdosis skal passende understøttende behandling i henhold til patientens kliniske status indledes.
English: Therefore, renal function and risk of volume depletion should be taken into account prior to starting treatment with Qtern.
Danish: Derfor bør nyrefunktionen og risikoen for volumendepletering tages i betragtning inden start af behandling med Qtern.
English: Qtern is not recommended during pregnancy and your doctor will ask you to stop taking this medicine if you become pregnant.
Danish: Qtern frarådes under graviditet, og lægen vil bede dig om at stoppe med at tage denne medicin, hvis du bliver gravid.
English: Possible signs of dehydration are listed at the top of section 4.
Danish: Mulige tegn på dehydering er anført øverst i punkt 4.
English: The volume of distribution of saxagliptin was 205 l.
Danish: Fordelingsvolumen af saxagliptin var 205 l.
English: Your doctor may ask you to stop taking Qtern until you recover to prevent dehydration.
Danish: Lægen vil måske bede dig stoppe med at tage Qtern, indtil du har det godt nok til at forhindre dehydrering.
English: p-value <0.0001.
Danish: p <0,0001.
English: The two active substances in Qtern work in different ways to help control the level of sugar in your blood and remove excess sugar from your body via your urine.
Danish: De to aktive stoffer i Qtern virker på forskellige måder og hjælper med at kontrollere niveauet af blodsukker og fjerne det overskydende sukker fra kroppen via urinen.
English: Volume depletion F,
Danish: Volumendepletering F,
English: • Prior to initiation of concomitant medicinal products that may reduce renal function and periodically thereafter.
Danish: • Før start på behandling med andre lægemidler, der kan nedsætte nyrefunktionen, og derefter regelmæssigt.
English: Saxagliptin: Elderly patients (65-80 years) had about 60 % higher saxagliptin AUC than young patients (18-40 years).
Danish: Saxagliptin: Ældre patienter (65-80 år) har omkring 60 % højere saxagliptin-AUC end yngre patienter (18-40 år).
English: In particular, if you are following a diabetic weight control diet, continue to follow it while you are taking Qtern.
Danish: Især hvis du følger en diabetesdiæt med vægtkontrol, skal du fortsat følge denne, mens du tager Qtern.
English: - if you have an increase in the amount of red blood cells in your blood, seen in tests.
Danish: • hvis du har et forhøjet antal røde blodlegemer, hvilket kan ses i blodprøver.
English: Qtern can be administered with or without food.
Danish: Qtern kan administreres med eller uden mad.
English: Each belongs to a group of medicines called “oral anti-diabetics”.
Danish: Begge tilhører en gruppe lægemidler, der kaldes orale antidiabetika.
English: Immunocompromised patients, such as patients who have undergone organ transplantation or patients diagnosed with human immunodeficiency syndrome have not been studied in the saxagliptin clinical programme.
Danish: Immunkompromitterede patienter, såsom patienter, der har gennemgået en organtransplantation, eller patienter, der er diagnosticeret med human immundefektsyndrom, er ikke blevet undersøgt i det kliniske program med saxagliptin.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Danish: • Når risikostyringssystemet ændres, særlig som følge af, at der er modtaget nye oplysninger, der kan medføre en væsentlig ændring i risk/benefit-forholdet, eller som følge af, at en vigtig milepæl (lægemiddelovervågning eller risikominimering) er nået.
English: The numerical imbalance of breast, bladder and prostate tumours must be considered with caution; it will be further investigated in post-authorisation studies.
Danish: Den numeriske ubalance for bryst-, blære- og prostatatumorer skal tolkes med varsomhed; den vil blive undersøgt nærmere i postmarketingstudier.
English: “Type 2 diabetes mellitus” is the type of diabetes that usually starts when you are older.
Danish: Type 2-diabetes mellitus er en type diabetes, der sædvanligvis starter, når du er ældre.
English: - You can take your tablet with or without food.
Danish: - Du kan tage tabletten med eller uden mad.
English: Qtern is not recommended for children and adolescents under 18 years of age, because it has not been studied in these patients.
Danish: Børn og unge Qtern frarådes til børn og unge under 18 år, da det ikke er undersøgt hos disse patienter.
English: Your doctor may prescribe other medicines to lower the amount of sugar in your blood.
Danish: Lægen kan udskrive anden medicin for at nedsætte mængden af sukker i blodet.
English: Dapagliflozin: There were no clinically relevant differences in systemic exposures between White, Black or Asian races.
Danish: Dapagliflozin: Der var ingen klinisk relevante forskelle i systemiske eksponeringer mellem den hvide, sorte eller asiatiske race.
English: The AUC values of 5-OH-saxagliptin were also increased.
Danish: AUC for 5-OH-saxagliptin var også øget.
English: Your doctor may decide to temporarily or permanently stop your treatment with Qtern.
Danish: Lægen kan beslutte at stoppe behandlingen med Qtern midlertidigt eller permanent.
English: UNIQUE IDENTIFIER HUMAN READABLE DATA
Danish: ENTYDIG IDENTIFIKATOR - MENNESKELIGT LÆSBARE DATA
English: Patients who completed the initial 24-week study period were eligible to enter a controlled 28-week long-term study extension (52 weeks).
Danish: De patienter, som fuldførte den indledende studieperiode på 24 uger, kunne deltage i et kontrolleret langvarigt forlængelsesstudie af 28 ugers varighed (i alt 52 uger).
English: - if you have a condition that reduces your body's ability to fight infections, such as a disease like AIDS or from medicines that you might take after an organ transplant.
Danish: • hvis du har en sygdom, der nedsætter din krops evne til at bekæmpe infektioner, såsom aids, eller hvis du tager medicin efter en organtransplantation.
English: - This medicine is taken by mouth for diabetes.
Danish: - Dette lægemiddel tages gennem munden mod diabetes (sukkersyge).
English: - if you are on medicines to lower your blood pressure (anti-hypertensives) and have a history of low blood pressure (hypotension).
Danish: • hvis du tager medicin for at sænke dit blodtryk (antihypertensiva) og har en sygehistorie med for lavt blodtryk (hypotension).
English: Polyvinyl alcohol (E1203) Macrogol 3350
Danish: Filmovertræk Polyvinylalkohol (E1203) Macrogol 3350
English: AstraZeneca UK Limited Silk Road Business Park Macclesfield Cheshire SK10 2NA
Danish: AstraZeneca UK Limited Silk Road Business Park Macclesfield Cheshire SK10 2NA Storbritannien
English: Treatment with dapagliflozin may be restarted when the ketone values are normal and the patient's condition has stabilised.
Danish: Behandlingen med dapagliflozin kan genoptages, når ketonstofværdierne er normale, og patientens tilstand er stabiliseret.
English: Proportion of patients achieving HbA1c < 7 %
Danish: Andel af patienter, der opnåede HbA1c < 7 %
English: This is not considered clinically meaningful, therefore, no dose adjustment for saxagliptin is recommended on the basis of age alone.
Danish: Dette anses ikke som klinisk relevant, og derfor anbefales dosisjustering af saxagliptin ikke alene på baggrund af alderen.
English: Clinically relevant factors predictive of increased relative risk with saxagliptin treatment could not be definitively identified.
Danish: Klinisk relevante faktorer, der er prædiktive for øget relativ risiko med saxagliptinbehandling, kunne ikke med sikkerhed identificeres.
English: Possible signs of losing too much fluid from your body are listed at the top of section 4.
Danish: Mulige tegn på for stort væsketab fra kroppen er anført øverst i punkt 4.
English: Monitoring of ketones is recommended in these patients.
Danish: Det anbefales, at disse patienter overvåges for ketonstoffer.
English: Patients should be advised of the characteristic symptoms of heart failure, and to immediately report such symptoms.
Danish: Patienterne skal informeres om de karakteristiske symptomer på hjertesvigt og om straks at indberette sådanne symptomer.
English: The renal pelvic and tubular dilatations observed in juvenile animals did not fully reverse within the approximate 1-month recovery period.
Danish: Dilatation af nyrebækken og -tubuli observeret hos unge dyr var ikke fuldt reversibel inden for en restitutionsperiode på ca. 1 måned.
English: p-value=0.0166.
Danish: p = 0,0166.
English: Experience in NYHA class III-IV is limited with saxagliptin.
Danish: Erfaring med NYHA klasse III-IV er begrænset for saxagliptin.
English: diarrhoea, dyspepsia
Danish: diarré, dyspepsi
English: Symptoms can include, but are not limited to, increasing shortness of breath, rapid increase in weight and swelling of the feet (pedal oedema).
Danish: Symptomerne kan omfatte, men er ikke begrænset til, stigende åndenød, hurtig vægtstigning og hævede fødder (ødemer i fødderne).
English: - This medicine is used if your diabetes cannot be controlled with other oral diabetes medicines,
Danish: - Dette lægemiddel anvendes sammen med diæt og motion, hvis din diabetes ikke kan kontrolleres med andre orale lægemidler til behandling af diabetes.
English: Consequently, low-weight patients may have somewhat increased exposure and patients with high-weight somewhat decreased exposure.
Danish: Som følge heraf kan patienter med lav vægt have en noget højere eksponering og patienter med høj vægt en noget lavere eksponering.
English: Females had approximately 25% higher systemic-exposure values for saxagliptin, this difference is considered not clinically relevant.
Danish: Kvinder havde ca. 25 % højere værdier for systemisk eksponering for saxagliptin; denne forskel anses ikke for klinisk relevant.
English: Your doctor may prescribe a medicine to treat your allergic reaction and a different medicine for your diabetes.
Danish: Lægen kan udskrive medicin til behandling af din allergiske reaktion og en anden medicin til behandling af din sukkersyge.
English: It is not known if this medicine passes into human breast milk.
Danish: Det vides ikke, om medicinen passerer over i mælken hos mennesker.
English: - if you are taking a medicine to lower your blood sugar, such as insulin or sulphonylureas.
Danish: • hvis du tager et lægemiddel for at sænke blodsukkeret, såsom insulin eller sulfonylurinstof.
English: Do not take Qtern: - if you are allergic to saxagliptin, dapagliflozin or any of the other ingredients of this medicine (listed in section 6).
Danish: Tag ikke Qtern: - hvis du er allergisk over for saxagliptin, dapagliflozin eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i punkt 6).
English: Onset of symptoms following initiation of therapy may be rapid or may occur after longer periods of treatment.
Danish: Symptomdebut kan opstå hurtigt efter behandlingsstart eller efter længere behandlingsperioder.
English: Like for all diabetic patients it is important to counsel patients on routine preventative foot care.
Danish: Som det gælder for alle diabetespatienter, at det er vigtigt at informere patienterne om rutinemæssig forebyggende fodpleje.
English: Necrotising fasciitis of the perineum (Fournier's gangrene)
Danish: Nekrotiserende fasciitis i perineum (Fourniers gangræn)
English: Following a single 50 mg dose of
Danish: Efter en enkeltdosis på 50 mg
English: Frequencies of all uncommon adverse reactions were based on the individual mono-components data.
Danish: Hyppigheden for alle ikke almindelige bivirkninger er baseret på data for enkeltstofferne.
English: Urinary uric acid excretion was also increased transiently (for 3-7 days) and accompanied by a sustained reduction in serum uric acid concentration.
Danish: Udskillelse af urinsyre i urinen øgedes ligeledes forbigående (i 3-7 dage) ledsaget af en vedvarende reduktion i serumurinsyre.
English: Patients should be informed of the characteristic symptoms of acute pancreatitis; persistent, severe abdominal pain.
Danish: Patienterne skal informeres om de karakteristiske symptomer på akut pankreatitis: vedvarende, svære abdominalsmerter.
English: Before initiating Qtern, factors in the patient history that may predispose to ketoacidosis should be considered.
Danish: Inden behandlingen med Qtern påbegyndes, skal faktorer i patientens anamnese, der kan prædisponere for ketoacidose, vurderes.
English: If Fournier's gangrene is suspected, Qtern should be discontinued and prompt treatment (including antibiotics and surgical debridement) should be instituted.
Danish: Hvis der er mistanke om Fourniers gangræn, bør Qtern seponeres, og øjeblikkelig behandling (herunder antibiotika og kirurgisk debridement) bør iværksættes.
English: This is a medicine used to treat angina (chest pain) and lower blood pressure.
Danish: - Diltiazem, der anvendes til behandling af angina (brystsmerter) og til at sænke blodtrykket.
English: The efficacy and safety profile of Qtern in these patients has not been established.
Danish: Qterns effekt og sikkerhedsprofil er ikke klarlagt hos disse patienter.
English: Elderly patients are more likely to have impaired renal function, and may be at a greater risk for volume depletion.
Danish: Ældre patienter har større sandsynlighed for at have nedsat nyrefunktion og kan have en større risiko for volumendepletering.
English: HbA1c change from baseline at week 24 excluding data after rescue for randomised subjects - studies MB102129 and CV181168
Danish: HbA1c-ændring fra baseline til uge 24 eksklusive data efter rescue-medicin for randomiserede forsøgspersoner - studie MB102129 og CV181168
English: In a separate pre-specified subgroup analysis, mean reductions from baseline in HbA1c were generally greater for patients with higher baseline HbA1c values.
Danish: I en separat præspecificeret subgruppeanalyse var de gennemsnitlige reduktioner i HbA1c i forhold til baseline generelt større for patienter med højere HbA1c-værdier ved baseline.
English: Therefore, dapagliflozin is not expected to alter the metabolic clearance of coadministered medicinal products that are metabolised by these enzymes.
Danish: Det forventes derfor ikke, at dapagliflozin ændrer den metaboliske clearance af samtidigt administrerede lægemidler, der metaboliseres af disse enzymer.
English: In a number of cases, the presentation of the condition was atypical with only moderately increased blood glucose values, below 14 mmol/litres (250 mg/dl).
Danish: I et antal tilfælde fremstod tilstanden atypisk, idet der kun var moderat forhøjet blodglucose, under 14 mmol/liter (250 mg/dl).
English: The clinical relevance of the skin lesions is not known and skin lesions have not been observed in humans.
Danish: Den kliniske relevans af hudlæsionerne kendes ikke, og der er ikke observeret hudlæsioner hos mennesker.
English: The absolute oral bioavailability of dapagliflozin following the administration of a 10 mg dose is 78 %.
Danish: Den absolutte orale biotilgængelighed af dapagliflozin efter indgivelse af en dosis på 10 mg er 78 %.
English: These pharmacokinetic effects are not clinically meaningful and do not require dose adjustment.
Danish: Disse farmakokinetiske virkninger er ikke klinisk relevante, og dosisjustering er ikke nødvendig.
English: If you stop taking Qtern
Danish: Hvis du holder op med at tage Qtern
English: SU = sulphonylurea
Danish: SU = sulfonylurinstof
English: Saxagliptin: Females had approximately 25 % higher systemic exposure values for saxagliptin.
Danish: Saxagliptin: Kvinder havde ca. 25 % højere systemisk eksponering for saxagliptin.
English: - if you have very high levels of sugar in your blood which may make you dehydrated (lose too much body fluid).
Danish: • hvis du har meget høje niveauer af sukker i blodet, så du taber for meget kropsvæske (dehydrering).
English: Anaphylactic reactions including anaphylactic shock
Danish: Anafylaktiske reaktioner inklusive anafylaktisk shock
English: Mean absolute lymphocyte counts remained stable with daily dosing up to 102 weeks in duration.
Danish: Det gennemsnitlige absolutte lymfocyttal forblev stabilt ved daglig dosering i op til 102 uger.
English: Compilation of reported adverse reactions for Qtern
Danish: Sammenfatning af rapporterede bivirkninger for Qtern
English: The European Medicines Agency has waived the obligation to submit the results of studies with Qtern 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 Qtern i alle undergrupper af den pædiatriske population ved behandling af type 2-diabetes (se pkt.
English: - if you are taking another medicine for diabetes that contains “pioglitazone”.
Danish: • hvis du tager et andet lægemiddel mod diabetes, som indeholder pioglitazon.
English: Saxagliptin: In a pool of 5 placebo-controlled studies, a small decrease in absolute lymphocyte count was observed, approximately 100 cells/microl relative to placebo.
Danish: Saxagliptin: I en pulje med 5 placebokontrollerede studier blev der observeret et lille fald i absolut lymfocyttal, ca. 100 celler/mikroliter i forhold til placebo.
English: Thus, changes in blood protein levels in various disease states (e.g. renal or hepatic impairment) are not expected to alter the disposition of saxagliptin.
Danish: Derfor forventes ændringer i blodproteinniveauer ved forskellige sygdomstilstande (f.eks. nedsat nyre- eller leverfunktion) ikke at ændre fordelingen af saxagliptin.
English: Temporary interruption of treatment with this medicinal product is recommended for patients who develop volume depletion until the depletion is corrected (see section 4.8).
Danish: Midlertidig afbrydelse af behandlingen med dette lægemiddel anbefales hos patienter, som udvikler volumendepletering, indtil depleteringen er korrigeret (se pkt.
English: There was no food effect observed for saxagliptin.
Danish: Der blev ikke observeret nogen effekt fra fødevarer for saxagliptin.
English: n = number of subjects with non-missing baseline and a Week 24 value.
Danish: n = antal forsøgspersoner med baseline-værdi og uge 24-værdi.
English: Erectile dysfunction, pruritus genital, vulvovaginal pruritus
Danish: Erektil dysfunktion, genital pruritus, vulvovaginal pruritus
English: Generally, the most common adverse events reported in ≥ 65 years old were similar to < 65 years old.
Danish: Generelt var de hyppigst rapportede bivirkninger hos forsøgspersoner ≥ 65 år de samme som hos forsøgspersoner < 65 år.
English: Dapagliflozin: There is no clinically meaningful increase in exposure based on age alone in subjects up to 70 years old.
Danish: Dapagliflozin: Der er ingen klinisk relevant stigning i eksponeringen baseret på alder alene hos forsøgspersoner op til 70 år.
English: In patients with type 2 diabetes, administration of saxagliptin inhibited DPP-4 enzyme activity throughout a 24-hour period.
Danish: Hos patienter med type 2-diabetes medførte administration af saxagliptin hæmning af DPP-4-enzymaktiviteten i en 24-timers periode.
English: If a dose is missed and it is ≥ 12 hours until the next dose, the dose should be taken.
Danish: Hvis en dosis glemmes, og der er ≥ 12 timer til næste dosis, skal dosen tages.
English: - if you have or have had a serious hypersensitivity reaction or is suspected.
Danish: • hvis du har eller tidligere har haft en alvorlig allergisk reaktion, eller der er mistanke om dette.
English: Patients experienced relief of symptoms after discontinuation of the medicinal product and some experienced recurrence of symptoms with reintroduction of the same or another DPP-4 inhibitor.
Danish: Patienterne oplevede lindring af symptomerne efter seponering af lægemidlet, og nogle oplevede, at symptomerne vendte tilbage, når behandling med den samme eller en anden DPP-4-hæmmer blev genoptaget.
English: Qtern is not expected to affect you being able to drive a car or use any tools or machines.
Danish: Qtern forventes ikke at påvirke din evne til at køre bil eller benytte værktøj eller maskiner.
English: The effect in HbA1c observed at Week 24 was sustained at Week 52.
Danish: Virkningen på HbA1c observeret i uge 24 blev opretholdt til uge 52.
English: Maternal toxicity was evident only at the highest dose tested, and limited to transient reductions in body weight and food consumption at dose.
Danish: Maternel toksicitet blev kun påvist ved den højeste testede dosis og var begrænset til forbigående reduktion i legemsvægt og foderindtagelse ved dosering.
English: Be aware that either uro-genital infection or perineal abscess may precede necrotising fasciitis.
Danish: Vær opmærksom på, at såvel urogenitale infektioner som abscesser i mellemkødet kan optræde før forekomst af nekrotiserende fasciitis.
English: HbA1c (%) at week 24
Danish: HbA1c (%) ved uge 24
English: UNIQUE IDENTIFIER 2D BARCODE
Danish: 17 ENTYDIG IDENTIFIKATOR - 2D-STREGKODE
English: Polyuria includes the following preferred terms: polyuria, and pollakiuria.
Danish: Polyuri inkluderer følgende foretrukne termer: polyuri og pollakisuri.
English: Saxagliptin: Race was not identified as a statistically significant covariate on the apparent clearance of saxagliptin and its metabolite.
Danish: Saxagliptin: Race blev ikke identificeret som en statistisk signifikant kovariat for den tilsyneladende clearance af saxagliptin eller metabolitten.
English: Stop taking Qtern and see a doctor straight away if you notice any of the following serious side effects:
Danish: Stop med at tage Qtern og opsøg hurtigst muligt en læge, hvis du får nogen af følgende alvorlige bivirkninger:
English: The inhibition of plasma DPP-4 activity by saxagliptin for at least 24 hours after oral administration of saxagliptin is due to high potency, high affinity, and extended binding to the active site.
Danish: Hæmningen af plasma-DPP-4-aktiviteten i mindst 24 timer efter oral administration af saxagliptin skyldes høj potens, høj affinitet og forlænget binding til det aktive sted.
English: - if you suffer from heart failure or you have other risk factors for developing heart failure such as problems with your kidneys.
Danish: • hvis du lider af hjertesvigt, eller hvis du har andre risikofaktorer for at udvikle hjertesvigt, såsom nyreproblemer.
English: Česká republika AstraZeneca Czech Republic s.r.o.
Danish: AstraZeneca Czech Republic s.r.o.
English: Mechanism of action for Qtern
Danish: Virkningsmekanisme for Qtern
English: Measurement of blood ketone levels is preferred to urine.
Danish: Niveauet af ketonstoffer bør måles i blodet snarere end i urinen.
English: The corresponding plasma Cmax values were 24 ng/ml and 47 ng/ml,
Danish: Den tilsvarende plasma-Cmax var henholdsvis 24 ng/ml og 47 ng/ml.
English: Available epidemiological data for pioglitazone suggest a small increased risk of bladder cancer in diabetic patients treated with pioglitazone.
Danish: De foreliggende epidemiologiske data for pioglitazon tyder på en let øget risiko for blærekræft hos diabetespatienter, der får pioglitazon.
English: You are advised to follow the recommendations for skin care that you are given by your doctor or nurse.
Danish: Du rådes til at følge de anbefalinger for hudpleje, som din læge eller sygeplejerske har givet dig.
English: Randomised and treated patients with baseline and at least 1 post-baseline efficacy measurement.
Danish: Randomiserede og behandlede patienter med baseline-værdi og mindst 1 post-baseline-effektmåling.