FrancophonIA/ELRC3.0 huggingface dataset:
English: In the study of myocardial infarction with ST segment elevation, Arixtra reduced the risk of death or another heart attack by 14% after 30 days, compared to standard care.
Danish: I undersøgelsen af myokardieinfarkt med ST-segmentforhøjelse reducerede Arixtra risikoen for død eller endnu et hjerteanfald med 14 % efter 30 dage i sammenligning med en standardbehandling.
English: For patients who have kidney problems, Arixtra may not be suitable, or the 1.5-mg dose may be used.
Danish: Arixtra er muligvis ikke egnet til patienter med nyreproblemer, eller den lavere dosis på 1,5 mg kan anvendes.
English: Arixtra is not recommended in patients who are about to undergo certain types of operations to unblock the heart's blood vessels.
Danish: Arixtra anbefales ikke til patienter, som skal have foretaget visse former for operationer, som skal udvide blodkarrene i hjertet.
English: Why has Arixtra been approved?
Danish: Hvorfor blev Arixtra godkendt?
English: Arixtra was at least as effective as enoxaparin in preventing death or an ischaemic event in patients with unstable angina or myocardial infarction without ST segment elevation, with around 5% of the patients in each group had died or had an ischaemic event after nine days.
Danish: Arixtra var mindst lige så effektivt som enoxaparin til at forebygge død eller iskæmiske hændelser, selv hos patienter med ustabil angina eller myokardieinfarkt uden ST-segmentforhøjelse, idet ca. 5 % af patienterne i hver gruppe var døde eller havde haft en iskæmisk hændelse efter ni dage.
English: The active ingredient in Arixtra, fondaparinux sodium, stops one of the substances (factors) that are involved in the clotting of blood, factor Xa.
Danish: Det aktive stof i Arixtra, fondaparinuxnatrium, blokerer et af de stoffer, faktor Xa, der medvirker ved blodets størkning.
English: It can also be used in adults at high risk (because of their age or disease) when they are having abdominal surgery or are forced to stay in bed because of an acute illness.
Danish: Det kan desuden anvendes til voksne patienter, der på grund af alder eller sygdommens art er i højrisikogruppen i forbindelse med et mavekirurgisk indgreb eller fordi de er sengeliggende på grund af akut sygdom.
English: By using Arixtra after surgery, the risk of a blood clot forming is greatly reduced.
Danish: Brug af Arixtra efter operationen begrænser risikoen for blodpropdannelse væsentligt.
English: Arixtra was more effective than placebo in reducing the overall occurrence of VTE or death in patients with superficial vein thrombosis.
Danish: Arixtra var mere effektivt end placebo til at reducere den samlede forekomst af venøs tromboemboli og dødsfald hos patienter med overfladisk venetrombose.
English: What is Arixtra?
Danish: Hvad er Arixtra?
English: For the full list of all side effects reported with Arixtra, see the package leaflet.
Danish: Den fuldstændige liste over de indberettede bivirkninger ved Arixtra fremgår af indlægssedlen.
English: While there was one VTE or death for every 100 patients taking Arixtra, there were six for every hundred taking placebo.
Danish: Forekomsten var ét tilfælde af venøs tromboemboli eller dødsfald for hver 100 patienter, som fik Arixtra, i modsætning til seks tilfælde for hver 100 patienter blandt dem, der fik placebo.
English: For patients with unstable angina or myocardial infarction, the recommended dose is 2.5 mg once daily by subcutaneous injection, but the first dose is given intravenously (into a vein) through an existing line or as an infusion (drip) in patients with ST segment elevation.
Danish: For patienter med ustabil angina eller myokardieinfarkt er den anbefalede dosis 2,5 mg en gang daglig ved subkutan injektion, men den første dosis gives intravenøst (i en vene) via et eksisterende kateter eller som en infusion (drop) hos patienter med ST-segmentforhøjelse.
English: In the prevention studies, Arixtra was compared with other anticoagulants: enoxaparin (in hip or knee surgery; over 8,000 patients) or dalteparin (in abdominal surgery; 2,927 patients).
Danish: I undersøgelserne vedrørende forebyggelse blev Arixtra sammenlignet med andre antikoagulerende midler: enoxaparin (ved hofte- og knæoperationer, over 8 000 patienter) eller dalteparin (ved abdominal kirurgi, 2 927 patienter).
English: The 2.5 mg strength is also used to treat adults with unstable angina (a type of chest pain that changes in severity due to reduced blood flow to the heart) or who are having a myocardial infarction (heart attack) with or without ‘ST segment elevation' (an abnormal reading on the electrocardiogram or ECG).
Danish: 2,5 mg-styrken anvendes også til at behandle voksne patienter med ustabil angina (en form for brystsmerter af skiftende sværhedsgrad som følge af ringe blodforsyning til hjertet), eller som har et myokardieinfarkt (hjerteanfald) med eller uden ‘ST-segmentforhøjelse' (en abnorm måling på elektrokardiogrammet, EKG)
English: Arixtra is a solution for injection in a prefilled syringe.
Danish: Arixtra er en opløsning til injektion i en fyldt injektionssprøjte.
English: The overall rate of thrombotic events in patients treated with Arixtra was significantly less than in patients treated with placebo or enoxaparin (for patients undergoing leg surgery), and was similar to that seen with enoxaparin (treatment of DVT), dalteparin or unfractionated heparin.
Danish: Den samlede forekomst af trombotiske hændelser hos patienter behandlet med Arixtra var betydeligt lavere end hos patienter behandlet med placebo eller enoxaparin (for patienter opereret i benene) og svarede til enoxaparin (ved behandling af blodpropper i de dybe vener), dalteparin eller ufraktioneret heparin.
English: The first compared the effects of Arixtra with those of enoxaparin in over 20,000 patients with unstable angina or myocardial infarction without ST segment elevation, and the second compared Arixtra with standard care (unfractionated heparin in eligible patients, or placebo) in over 12,000 patients with myocardial infarction with ST segment elevation.
Danish: I den første sammenlignedes virkningen af Arixtra med virkningen af enoxaparin hos over 20 000 patienter med ustabil angina eller myokardieinfarkt uden ST-segmentforhøjelse, og i den anden sammenlignedes Arixtra med en standardbehandling (ufraktioneret heparin hos egnede patienter eller placebo) hos over 12 000 patienter med myokardieinfarkt med ST-segmentforhøjelse.
English: Arixtra should not be used in people who may be hypersensitive (allergic) to fondaparinux sodium or any of the other ingredients, who might be bleeding already, who have acute bacterial endocarditis (an infection of the heart) or have severe kidney problems.
Danish: Arixtra bør ikke anvendes til patienter, som kan være overfølsomme (allergiske) over for fondaparinuxnatrium eller andre af indholdsstofferne, til patienter, som i forvejen bløder, patienter med akut bakteriel endocarditis (en infektion i hjertet) eller patienter med stærkt nedsat nyrefunktion.
English: Arixtra (1.5 and 2.5 mg strengths) is also used to treat adults who have blood clots in the superficial veins of the legs (superficial venous thrombosis) but not in their deep veins (deep vein thrombosis, DVT).
Danish: Arixtra (i styrkerne 1,5 and 2,5 mg) anvendes desuden til behandling af voksne, som har blodpropper i de overfladiske vener i benene (overfladisk venetrombose), men ikke i de dybtliggende vener (dyb venetrombose, DVT).
English: The main measure of effectiveness of this study was the overall occurrence of VTE or death.
Danish: Hovedmålet for virkningen i denne undersøgelse var den samlede forekomst af venøs tromboemboli eller dødsfald.
English: Arixtra was at least as effective as the comparators in all of the studies that looked at the prevention of VTE and treatment of DVT and PE.
Danish: Arixtra var mindst lige så effektivt som sammenligningspræparaterne i de undersøgelser, som så på forebyggelse af venøs tromboemboli og behandling af dyb venetrombose og lungeemboli.
English: Arixtra has been studied for the prevention of and in the treatment of VTE.
Danish: Arixtra er blevet undersøgt med henblik på forebyggelse og behandling af venøs tromboemboli.
English: At higher strengths (5, 7.5 and 10 mg), Arixtra is used to treat DVT or pulmonary embolism (PE, clot in a blood vessel supplying the lungs).
Danish: Arixtra anvendes ved højere styrker (5, 7,5 og 10 mg) til at behandle dyb venetrombose eller lungeemboli (PE, en blodprop i et blodkar, som fører blod til lungerne).
English: In the treatment of superficial vein thrombosis, Arixtra was compared with placebo in one study of 3,000 patients with superficial vein thrombosis of the legs, without DVT.
Danish: Til behandling af overfladisk venetrombose blev Arixtra sammenlignet med placebo (virkningsløs behandling) i en undersøgelse af 3 000 patienter med overfladisk venetrombose i benene og uden dyb venetrombose.
English: Arixtra (1.5 and 2.5 mg strengths) is used to prevent venous thromboembolic events (VTEs, problems due to the formation of blood clots in the veins) in adults (aged 18 years or over) who are having major surgery to their legs, such as a hip or knee surgery.
Danish: Arixtra (i styrkerne 1,5 og 2,5 mg) anvendes til forebyggelse af venøse tromboemboliske hændelser (dvs. problemer som følge af blodpropper i venerne) hos voksne på 18 år og derover, der får foretaget større operationer i benene, f.eks. hofte- eller knæoperationer.
English: What benefit has Arixtra shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Arixtra?
English: How has Arixtra been studied?
Danish: Hvordan blev Arixtra undersøgt?
English: What is Arixtra used for?
Danish: Hvad anvendes Arixtra til?
English: Arixtra is an anticoagulant: it prevents the blood from coagulating (clotting).
Danish: Det forhindrer blodet i at koagulere (størkne).
English: In the prevention of VTEs, the recommended dose of Arixtra is 2.5 mg once a day by subcutaneous injection (under the skin).
Danish: Til forebyggelse af venøs tromboemboli er den anbefalede dosis af Arixtra 2,5 mg én gang dagligt, indgivet ved subkutan injektion (indsprøjtning under huden).
English: How is Arixtra used?
Danish: Hvordan anvendes Arixtra?
English: In the treatment of DVT or PE, the recommended dose is 7.5 mg once a day by subcutaneous injection, usually for seven days.
Danish: Til behandling af blodpropper i de dybe vener eller lungeemboli er den anbefalede dosis 7,5 mg én gang dagligt, normalt i syv dage.
English: It was also compared with placebo (a dummy treatment) when looking at patients with an acute illness (839 patients) and patients treated for an additional 24 days following hip fracture surgery (656 patients).In the treatment of VTE such as DVT and PE, Arixtra was compared with enoxaparin (DVT: 2,192 patients) or with unfractionated heparin (PE: 2,184 patients).
Danish: Det blev også sammenlignet med placebo (virkningsløs behandling) hos patienter med akut sygdom (839 patienter) og patienter, der blev behandlet i yderligere 24 dage efter en operation for hoftebensbrud (656 patienter).
English: In the treatment of superficial vein thrombosis, the recommended dose is 2.5 mg once a day by subcutaneous injection.
Danish: Til behandling af overfladisk venetrombose er den anbefalede dosis 2,5 mg én gang dagligt ved subkutan injektion (under huden).
English: How does Arixtra work?
Danish: Hvordan virker Arixtra?
English: These conditions can cause dehydration.
Danish: Disse forhold kan medføre dehydrering.
English: It is important to tell your doctor if you are taking:
Danish: Det er vigtigt at fortælle lægen, hvis du tager
English: Follow your doctor's instructions about stopping and re-starting your medicine.
Danish: Følg lægens anvisninger om at stoppe med eller at genoptage din medicin
English: Therefore, serum creatinine levels should be determined before initiating treatment and regularly thereafter:
Danish: Serumkreatinin skal derfor måles før initiering af behandlingen og derefter regelmæssigt:
English: a derived from postmarketing experience b see section 4.4
Danish: Baseret på rapporter efter markedsføring b Se pkt 4.4
English: Gastrointestinal symptoms3, 5
Danish: Gastrointestinale symptomer3, 5
English: The recommended dose is one tablet twice daily.
Danish: Den anbefalede dosis er én tablet to gange daglig.
English: In these cases, it is also recommended to check renal function before initiating treatment with Synjardy.
Danish: I disse tilfælde anbefales det også at kontrollere nyrefunktionen, inden behandling med Synjardy påbegyndes.
English: Synjardy can also be combined with other medicines.
Danish: Synjardy kan også bruges sammen med andre lægemidler.
English: Diet and exercise can help your body use its blood sugar better.
Danish: Kostomlægning og motion kan hjælpe din krop med at udnytte blodsukkeret bedre.
English: MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Danish: FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE B. BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVRING OG ANVENDELSE C. ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN D. BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET
English: • at least annually in patients with normal renal function
Danish: • Mindst én gang årligt hos patienter med normal nyrefunktion.
English: Erythema3 Urticaria3
Danish: Erytem3 Urticaria3
English: Make sure to ask your doctor for advice regarding when you can start your treatment again;
Danish: Spørg din læge til råds om, hvornår du kan starte behandlingen igen
English: These may be medicines taken by mouth or insulin given by injection.
Danish: Det kan være lægemidler, der tages gennem munden, eller insulin, der indgives som indsprøjtning.
English: Synjardy should be discontinued, at least temporarily, until the situation is clarified.
Danish: Behandlingen med Synjardy skal afbrydes, i hvert fald midlertidigt, indtil situationen er afklaret.
English: Combinations not recommended
Danish: Ikke-anbefalede kombinationsbehandlinger
English: 2 hour post-prandial glucose
Danish: Postprandial glukose efter 2 timer
English: The patient should be informed and more frequent blood glucose monitoring performed, especially at the beginning of treatment with such medicinal products.
Danish: Patienten bør informeres herom, og blodsukkeret bør kontrolleres hyppigere, især i starten af behandling med sådanne lægemidler.
English: Metformin increases the transport capacity of all types of membrane glucose transporters (GLUTs) known to date.
Danish: Metformin øger transportkapaciteten af alle hidtil kendte typer membranglukosetransportører (GLUT).
English: • at least two to four times a year in patients with serum creatinine levels at the upper limit of normal and in elderly subjects
Danish: • Mindst to til fire gange årligt hos patienter med serumkreatinin i overkanten af det normale og hos ældre patienter.
English: 24 hour SBP at week 123
Danish: 24 timers SBP i uge 123
English: In the acute conditions listed, metformin should be temporarily discontinued.
Danish: Ved de angivne akutte tilstande skal metforminbehandling afbrydes midlertidigt.
English: Hypoglycaemia (when used with sulphonylurea or insulin)1
Danish: Hypoglykæmi (ved brug sammen med sulfonylurinstof eller insulin)1
English: Difference from glimepiride1 (97.5% CI)
Danish: Forskel til glimepirid1 (97,5 % CI)
English: (95% CI) 24 hour DBP at week 123
Danish: (95 % CI) 24 timers DBP i uge 123
English: As this medicinal product contains metformin, the treatment must be discontinued 48 hours before elective surgery with general, spinal or peridural anaesthesia.
Danish: Da dette lægemiddel indeholder metformin, skal behandlingen midlertidigt seponeres 48 timer før en elektiv operation med generel, spinal eller peridural anæstesi.
English: • if you need to have an injection of contrast agent that contains iodine, for example before an X-ray or scan.
Danish: • hvis du skal have en indsprøjtning med et kontraststof, der indeholder jod, f.eks. før en røntgenundersøgelse eller en scanning.
English: If necessary, the dose of the anti-hyperglycaemic medicinal product should be adjusted during therapy with the other medicinal product and on its discontinuation.
Danish: Om nødvendigt bør dosis af det antihyperglykæmiske middel justeres under behandlingen med det andet lægemiddel og ved seponering af dette.
English: Table 1 Adverse reactions reported in placebo-controlled studies System organ class
Danish: Tabel 1: Bivirkninger indberettet i placebokontrollerede studier Systemorganklasse
English: (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), or very rare (<1/10,000), and not known (cannot be estimated from the available data).
Danish: Hyppigheden defineres 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: • a medicine used to remove water from the body (diuretic), as Synjardy may increase the risk of losing too much fluid.
Danish: • et lægemiddel, der bruges til at fjerne vand i kroppen (diuretika), da Synjardy kan øge risikoen for tab af kropsvæske.
English: However, temporary interruption of treatment should be considered in patients with complicated urinary tract infections.
Danish: Midlertidig seponering af behandlingen bør overvejes hos patienter med komplicerede urinvejsinfektioner.
English: • if you are going to have an operation under anaesthesia.
Danish: • hvis du skal opereres under bedøvelse.
English: Vaginal moniliasis, vulvovaginitis, balanitis and other genital infection1, 2
Danish: Vaginal moniliasis, vulvovaginitis, balanitis og andre genitale infektioner1, 2
English: The amount of glucose removed by the kidney through this glucuretic mechanism is dependent on blood glucose concentration and GFR.
Danish: Mængden af glukose, der fjernes af nyrerne via denne glukuretiske mekanisme, afhænger af koncentrationen af glukose i blodet og af GFR.
English: • in patients already being treated with the combination of empagliflozin and metformin as separate tablets.
Danish: • hvis patienten allerede er i behandling med en kombination af empagliflozin og metformin som særskilte tabletter
English: Stop taking Synjardy and see a doctor as soon as possible if you notice any of the following serious or potentially serious side effects:
Danish: Stop med at tage Synjardy og søg læge hurtigst muligt, hvis du bemærker nogle af følgende alvorlige, eller muligt alvorlige, bivirkninger:
English: (95% CI) a Full analysis set (FAS)
Danish: (95 % CI) a Fuldstændigt analysedatasæt (FAS).
English: Further symptoms are reduced body temperature and heart beat.
Danish: Andre symptomer er nedsat kropstemperatur og hjertebanken.
English: - Film coating: hypromellose, macrogol 400, titanium dioxide (E171), talc.
Danish: − Filmovertræk: hypromellose, macrogol 400, titandioxid (E171), talcum.
English: Analysis of the results for overweight patients treated with metformin after failure of diet alone showed:
Danish: Analyse af resultaterne for overvægtige patienter, der blev behandlet med metformin efter manglende effekt af kostomlægning alene, viste:
English: In a prospective, pre-specified meta-analysis of independently adjudicated cardiovascular events from 12 phase 2 and 3 clinical studies involving 10,036 patients with type 2 diabetes, empagliflozin did not increase cardiovascular risk.
Danish: I en prospektiv, præspecificeret metaanalyse af uafhængigt bedømte kardiovaskulære hændelser fra 12 kliniske fase II- og III-studier, som omfattede 10.036 patienter med type 2-diabetes, øgede empagliflozin ikke den kardiovaskulære risiko.
English: Body Weight (kg) at week 52b
Danish: Legemsvægt (kg) i uge 52b
English: Empagliflozin as add on to basal insulin
Danish: Empagliflozin som tillæg til basal insulin
English: • if you have problems with your kidneys;
Danish: • hvis du har problemer med nyrerne
English: Synjardy should not be used in patients with type 1 diabetes.
Danish: Synjardy må ikke bruges til patienter med type 1-diabetes.
English: • Empagliflozin works by blocking a protein in the kidneys called sodium glucose co-transporter 2 (SGLT2).
Danish: • Empagliflozin virker ved at blokere et protein i nyrerne, der kaldes for natrium-glukose co-transportør 2 (SGLT2).
English: • changes the way things taste
Danish: • Ændrer smagsfornemmelsen
English: The safety and efficacy of Synjardy in children and adolescents aged 0 to 18 years has not been established.
Danish: Synjardys sikkerhed og virkning hos børn og unge i alderen 0 til 18 år er ikke klarlagt, idet der ikke foreligger data.
English: Metformin The prospective randomised (UKPDS) study has established the long-term benefit of intensive blood glucose control in type 2 diabetes.
Danish: Metformin Det prospektive, randomiserede studie (UKPDS) har påvist en positiv langtidsvirkning af tæt blodglukosekontrol ved type 2-diabetes.
English: 1 See subsections below for additional information
Danish: 1 Se nedenstående underpunkter for nærmere information.
English: • Renal failure or renal dysfunction (creatinine clearance <60 ml/min).
Danish: • Nyresvigt eller nedsat nyrefunktion (kreatininclearance < 60 ml/min).
English: An urge to pass urine or more frequent urination may be due to the way Synjardy works, but as they can also be signs of urinary tract infection.
Danish: Stærk vandladningstrang eller hyppigere vandladning kan skyldes den måde, som Synjardy virker på, men det kan også være tegn på urinvejsinfektion.
English: Diagnosis
Danish: Diagnosticering
English: Lactic acidosis is a very rare, but serious (high mortality in the absence of prompt treatment), metabolic complication that can occur due to metformin accumulation.
Danish: Laktatacidose er en meget sjælden men alvorlig (høj dødelighed, hvis ikke der iværksættes omgående behandling) metabolisk komplikation, der kan opstå på grund af akkumulation af metformin.
English: Due to the metformin component, co-administration of anaesthesia can increase the risk of side effects.
Danish: På grund af metformin-komponenten kan samtidig administration af anæstesi forøge risikoen for bivirkninger.
English: Vitamin B12 deficiency3, 4
Danish: Vitamin B12mangel3, 4
English: • in patients inadequately controlled on their maximally tolerated dose of metformin alone
Danish: • hvis patienten har utilstrækkelig glykæmisk kontrol på den maksimalt tolererede dosis metformin alene
English: • and delay of intestinal glucose absorption.
Danish: • forsinkelse af den intestinale absorption af glukose.
English: This is a build-up of lactic acid in the blood that can cause death.
Danish: Der er tale om en ophobning af mælkesyre i blodet, og det kan medføre døden.
English: Decreased renal function in elderly patients is frequent and asymptomatic.
Danish: Nedsat nyrefunktion hos ældre patienter er hyppig og uden symptomer.
English: Patients should be instructed to notify these signs immediately to their physicians if they occur, notably if patients had a good tolerance to Synjardy before.
Danish: Patienterne skal informeres om straks at kontakte læge, hvis de får disse symptomer, navnlig hvis de hidtil har tålt Synjardy godt.
English: In the population pharmacokinetic analysis, AUC was estimated to be 13.5% higher in Asians with a body mass index of 25 kg/m2 compared to non-Asians with a body mass index of 25 kg/m2.
Danish: Ved den populationsfarmakokinetiske analyse blev AUC estimeret til at være 13,5 % højere hos asiater med et BMI på 25 kg/m2 sammenlignet med ikke-asiater med et BMI på 25 kg/m2.
English: Reintroduction of Synjardy should then be discussed taking into account the benefit/risk ratio in an individual basis as well as renal function.
Danish: Herefter kan administration af Synjardy igen overvejes under hensyntagen til benefit/risk-forholdet for den enkelte patient, herunder patientens nyrefunktion .