FrancophonIA/ELRC3.0 huggingface dataset:
English: Adverse reactions in patients treated for VTE1
Danish: Bivirkning hos patienter behandlet for VTE1)
English: Elderly patients - No dosing adjustment is necessary.
Danish: Ældre patienter - Dosisjustering er ikke nødvendig.
English: Fondaparinux does not bind significantly to other plasma proteins, including platelet factor 4 (PF4).
Danish: Fondaparinux bindes ikke væsentligt til andre plasmaproteiner, herunder platelet factor 4 (PF4).
English: If you forget to take Arixtra
Danish: Hvis du har glemt at tage Arixtra
English: The mean treatment duration was 6.2 days on fondaparinux.
Danish: Den gennemsnitlige behandlingsvarighed var 6,2 dage for fondaparinux.
English: The average duration of administration in clinical trials was 7 days and the clinical experience from treatment beyond 10 days is limited.
Danish: I kliniske forsøg varede behandlingen i gennemsnit 7 dage, og der er begrænset klinisk erfaring med behandling ud over 10 dage.
English: If co-administration is essential, close monitoring is necessary.
Danish: Såfremt samtidig administration er essentiel, bør behandling ske under tæt monitorering.
English: If fondaparinux sodium is added to a 0.9% saline minibag it should ideally be infused immediately, but can be stored at room temperature for up to 24 hours.
Danish: Hvis fondaparinuxnatrium tilsættes en minipose med 0,9 % saltopløsning bør infusionen ideelt set gives straks, men den kan opbevares ved stuetemperatur i op til 24 timer.
English: Medical patients who are at high risk for thromboembolic complications based on an individual risk assessment
Danish: Medicinske patienter med høj risiko for tromboemboliske komplikationer ud fra en individuel risikovurdering
English: Treatment should be continued for at least 5 days and until adequate oral anticoagulation is established (International Normalised Ratio 2 to 3).
Danish: Behandlingen fortsættes i mindst 5 dage, og indtil oral antikoagulation er tilfredsstillende (INRværdier, international normaliseret ratio, 2-3).
English: A randomised, open-label, clinical trial was conducted in patients with acute symptomatic PE.
Danish: Et randomiseret, åbent klinisk studie blev udført med patienter med akut symptomatisk PE.
English: The primary outcome was a composite of peri-PCI (defined as time of randomisation up to 48 hours post-PCI) adjudicated major or minor bleeding, or major vascular access site complications.
Danish: Det primære udfald var en kombination af peri-PCI (defineret som randomiseringstidspunkt op til 48 timer efter PCI) bedømt større eller mindre blødning eller større komplikationer på det vaskulære adgangssted.
English: Rare: non-protein-nitrogen (Npn) 2 increased
Danish: Sjælden: forhøjet nonprotein nitrogen (NPN) 2)
English: • Do not inject Arixtra into muscle.
Danish: • Arixtra må ikke injiceres i en muskel.
English: Twelve (0.37%) enrolled patients experienced thrombus in the arterial sheath, of these 7 were reported during angiography and 5 were reported during PCI.
Danish: 12 (0,37 %) inkluderede patienter oplevede trombe i den arterielle sheath; af disse blev 7 rapporteret under angiografi, og 5 blev rapporteret under PCI.
English: • treat some types of heart attack and severe angina (pain caused by narrowing of the arteries in the heart).
Danish: at behandle visse typer af hjerteanfald og alvorlige tilfælde af angina (smerte, som skyldes forsnævring i blodkarrene omkring hjertet).
English: Prevention of VTE following Surgery
Danish: Forebyggelse af VTE efter operation
English: Of the patients treated with a thrombolytic, 84% were treated with a non-fibrin specific agent (primarily streptokinase).
Danish: Af de patienter, som blev behandlet med fibrinolyse, blev 84 % behandlet med et ikke-fibrinselektivt fibrinolytikum (overvejende streptokinase).
English: The elderly population is at increased risk of bleeding.
Danish: Den ældre befolkning har generelt en øget blødningsrisiko.
English: Overdose associated with bleeding complications should lead to treatment discontinuation and search for the primary cause.
Danish: Overdosering med blødningskomplikationer bør føre til seponering af behandlingen og diagnose af den primære årsag.
English: To treat some types of heart attack, a health professional may give the first dose into a vein (intravenously).
Danish: Ved behandling af visse typer af hjerteanfald vil lægen give dig den første dosis i en vene (intravenøst).
English: However, studies performed in Asian (Japanese) healthy subjects did not reveal a different pharmacokinetic profile compared to Caucasian healthy subjects.
Danish: Imidlertid påviste studier med asiatiske (japanske), raske forsøgspersoner ingen forskel i den farmakokinetiske profil ved sammenligning med kaukasiske, raske forsøgspersoner.
English: Similarly, no plasma clearance differences were observed between black and Caucasian patients undergoing orthopaedic surgery.
Danish: Der blev heller ikke observeret forskelle i plasmaclearance mellem sorte og kaukasiske patienter, som gennemgik ortopædkirurgi.
English: Patients who required thrombolysis or embolectomy or vena cava filter were excluded.
Danish: Patienter med behov for trombolyse, embolektomi eller vena cava-filter blev udelukket.
English: The risk of these rare events may be higher with postoperative use of indwelling epidural catheters or the concomitant use of other medicinal products affecting haemostasis.
Danish: Risikoen for disse sjældne hændelser kan være højere ved postoperativ brug af epiduralkateter eller samtidig brug af andre lægemidler, som påvirker hæmostasen.
English: There are no adequate data from the use of fondaparinux in pregnant women.
Danish: Der foreligger ikke kliniske data om brugen af fondaparinux hos gravide kvinder.
English: Release the plunger and the needle will automatically withdraw from the skin and go back into the security sleeve where it will be locked permanently (picture F).
Danish: Slip stemplet igen, så nålen automatisk trækker sig ud af huden og op i en sikkerhedsmanchet, hvor den fastlåses permanent (fig. F).
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Danish: Yderligere information om dette lægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/
English: The elimination half-life (t½) is about 17 hours in healthy young subjects and about 21 hours in healthy elderly subjects.
Danish: Eliminationshalveringstiden (t½) er ca. 17 timer hos raske unge forsøgspersoner og ca. 21 timer hos raske ældre forsøgspersoner.
English: Efficacy was maintained up to Day 77 and was consistent across all predefined subgroups including patients with varicose veins and patients with superficial-vein thrombosis located below the knee.
Danish: Virkningen blev opretholdt indtil dag 77 og var konsistent i alle prædefinerede subgrupper, inklusive patienter med åreknuder og patienter med superficiele venetromboser lokaliseret under knæet.
English: Body weight - Plasma clearance of fondaparinux increases with body weight (9% increase per 10 kg).
Danish: Legemsvægt - Plasmaclearance af fondaparinux stiger med stigende legemsvægt (9 % for hver 10 kg).
English: A treatment duration of 6-14 days has been clinically studied in medical patients (see section 5.1).
Danish: Et behandlingsforløb på 6-14 dage er undersøgt ved klinisk brug hos medicinske patienter (se pkt.
English: Treatment of Pulmonary Embolism
Danish: Behandling af lungeemboli
English: Four (0.3%) non-randomised patients experienced thrombus in the diagnostic catheter during coronary angiography.
Danish: 4 (0,3 %) ikke-randomiserede patienter oplevede trombe i det diagnostiske kateter under koronarangiografi.
English: Adverse reactions in medical patients
Danish: Bivirkninger hos medicinske patienter
English: The timing of restarting subcutaneous fondaparinux after sheath removal should be based on clinical judgment.
Danish: Tidspunktet for genoptagelse af subkutan fondaparinux efter fjernelse af sheath bør besluttes ud fra en klinisk vurdering.
English: Both treatment groups received Vitamin K antagonist therapy usually initiated within 72 hours after the first study drug administration and continued for 90 ± 7 days, with regular dose adjustments to achieve an INR of 2-3.
Danish: Begge grupper fik vitamin K-antagonist, og denne behandling blev sædvanligvis indledt i løbet af 72 timer efter første indgivelse af studiemedicin og fortsatte i 90 ± 7 dage med regelmæssig dosisjustering for at opnå INR 2-3.
English: Treatment should be continued for a minimum of 30 days and up to a maximum of 45 days in patients at high risk of thromboembolic complications (see sections 4.4 and 5.1).
Danish: Behandlingen bør fortsætte i mindst 30 dage og maksimalt i 45 dage hos patienter med høj risiko for tromboemboliske komplikationer (se pkt.
English: Contact your doctor or pharmacist before stopping.
Danish: Kontakt lægen eller apoteket, inden du stopper behandlingen.
English: MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLER(E) ANSVARLIG(E) FOR BATCHFRIGIVELSE
English: You should inject at about the same time each day.
Danish: Arixtra skal injiceres på samme tidspunkt hver dag.
English: Hold the fold between the thumb and the forefinger during the entire injection (picture C).
Danish: Hold folden mellem tommel- og pegefinger under hele injektionen (fig. C).
English: Fondaparinux is administered by deep subcutaneous injection while the patient is lying down.
Danish: Fondaparinux gives som dyb subkutan injektion, mens patienten ligger ned.
English: If you have kidney disease, the dose may be reduced to 1.5 mg once a day.
Danish: Hvis du lider af en nyresygdom, vil din dosis muligvis blive nedsat til 1,5 mg én gang daglig.
English: Picture 3.
Danish: Figur 3.
English: • Store below 25°C.
Danish: • Opbevares ved temperaturer under 25 °C.
English: The mean age of the patients was 61 years, and approximately 40% were at least 65 years old.
Danish: Patienternes gennemsnitsalder var 61 år, og ca. 40 % var mindst 65 år eller ældre.
English: All patients received standard treatments for STEMI, including primary PCI (31%), thrombolytics (45%) or no reperfusion (24%).
Danish: Alle patienter modtog standardbehandling for STEMI, i form af primær PCI (31 %), fibrinolyse (45 %) eller ingen reperfusion (24 %).
English: If follow up treatment with a Vitamin K antagonist is required, treatment with fondaparinux should be continued until the target INR value has been reached.
Danish: Hvis der er behov for opfølgende behandling med vitamin K-antagonist, skal behandlingen med fondaparinux fortsættes, indtil den tilsigtede værdi for INR nås.
English: • prevent the formation of blood clots during and shortly after a period of restricted mobility due to acute illness.
Danish: at forebygge dannelsen af blodpropper under og umiddelbart efter en periode med nedsat bevægelighed på grund af akut sygdom.
English: There are no data available on the effect of fondaparinux on human fertility.
Danish: Der er ingen tilgængelige data for fondaparinux' effekt på human fertilitet.
English: This medicinal product contains less than 23 mg of sodium in each dose and therefore is essentially sodium-free.
Danish: Denne medicin indeholder mindre end 23 mg natrium pr. dosis, dvs. den er i det væsentlige natriumfri.
English: Picture 1.
Danish: Figur 1.
English: Choose a place in the lower abdominal (tummy) area, at least 5 cm below your belly button (picture A).
Danish: Vælg et sted nederst på maven, mindst 5 cm fra navlen (fig. A).
English: Uncommon: pain, oedema, Rare: reaction at injection site (1) Isolated AEs have not been considered except if they were medically relevant.
Danish: Ikke almindelig: smerter, ødem Sjælden: lokal reaktion ved injektionssted 1) isolerede bivirkninger er kun taget i betragtning, hvis de havde medicinsk relevans.
English: The mean age of the patients was 67 years, and approximately 60% were at least 65 years old.
Danish: Patienternes gennemsnitsalder var 67 år og ca. 60 % var mindst 65 år.
English: Don't stop using Arixtra without advice
Danish: Stop ikke med at tage Arixtra uden vejledning
English: A similar pattern is observed in DVT and PE treatment patients.
Danish: Et tilsvarende mønster ses hos patienter, der behandles for DVT og PE.
English: Arixtra contains a synthetic substance called fondaparinux sodium.
Danish: Arixtra indeholder et syntetisk stof kaldet fondaparinuxnatrium.
English: The mean treatment duration was 5.5 days in the fondaparinux group and 5.2 days in the enoxaparin group.
Danish: Den gennemsnitlige behandlingsvarighed var 5,5 dage i gruppen, som fik fondaparinux, og 5,2 dage i gruppen, som fik enoxaparin.
English: Thus, fondaparinux is not expected to interact with other medicinal products in vivo by inhibition of CYP-mediated metabolism.
Danish: Derfor forventes det ikke, at fondaparinux vil interagere med andre lægemidler in vivo gennem hæmning af CYP-medieret metabolisme.
English: Peri-PCI minor bleeding
Danish: Peri-PCI mindre blødning
English: Follow-up therapy with another anticoagulant medicinal product If follow-up treatment is to be initiated with heparin or LMWH, the first injection should, as a general rule, be given one day after the last fondaparinux injection.
Danish: Opfølgende behandling med andre antikoagulantia Hvis den opfølgende behandling indledes med heparin eller lavmolekylært heparin, skal den første injektion generelt gives dagen efter den sidste injektion af fondaparinux.
English: Randomised patients could have been pre-treated with UFH during the screening phase but patients treated for more than 24 hours with therapeutic dose of anticoagulant or with uncontrolled hypertension were excluded.
Danish: Randomiserede patienter måtte have fået ufraktioneret heparin under screeningsfasen, men patienter, der havde fået antikoagulantia i terapeutiske doser i over 24 timer, eller som havde ukontrolleret hypertension, blev udelukket.
English: All patients received standard medical treatment for UA/NSTEMI, with 34% of patients undergoing PCI and 9% undergoing CABG.
Danish: Alle patienter fik medicinsk UA/NSTEMI-standardbehandling, 34 % fik foretaget PCI, og 9 % fik foretaget CABG.
English: • the solution is clear and colourless and doesn't contain particles
Danish: • at opløsningen er klar, farveløs og ikke indeholder partikler
English: • Arixtra is given by injection under the skin (subcutaneously) into a skin fold of the lower abdominal area.
Danish: • Arixtra injiceres under huden (subkutant) i en hudfold nederst på maven.
English: Picture B1
Danish: Figur B1
English: The adverse event profile reported in the ACS program is consistent with the adverse drug reactions identified for VTE prophylaxis.
Danish: Den bivirkningsprofil, som blev rapporteret i AKS-programmet, stemmer overens med de bivirkninger, som er identificeret ved forebyggelse af VTE.
English: • Do not touch the needle or allow it to touch any surface before the injection.
Danish: • Undgå at røre ved kanylen eller lade den komme i berøring med omgivelserne før injektionen.
English: Although not fully evaluated, there is no evidence of fondaparinux metabolism and in particular no evidence for the formation of active metabolites.
Danish: Selvom en fuldstændig evaluering ikke foreligger, er der ikke fundet tegn på metabolisme af fondaparinux eller dannelse af aktive metabolitter.
English: There are two types of syringes:
Danish: Der findes to typer injektionssprøjter:
English: Peri-PCI major or minor bleeding, or major vascular access site complications
Danish: Peri-PCI større eller mindre blødning eller større komplikationer på det vaskulære adgangssted
English: Secondary
Danish: Sekundær
English: The baseline characteristics and duration of fondaparinux treatment were comparable in both UFH
Danish: Baselinekarakteristika og behandlingsvarighed med fondaparinux var sammenlignelige i de to UFHgrupper.
English: The first dose of fondaparinux is administered intravenously and subsequent doses are administered by subcutaneous injection.
Danish: Den første fondaparinuxdosis skal administreres intravenøst, og efterfølgende doser skal administreres som subkutan injektion.
English: If you inject too much Arixtra
Danish: Hvis du har taget for meget Arixtra
English: There is no known antidote to fondaparinux.
Danish: Der er ingen kendt antidot til fondaparinux.
English: If they do, you must not use Arixtra.
Danish: Hvis det gør, må du ikke tage Arixtra.
English: Below 50 kg
Danish: Under 50 kg
English: Other antiplatelet medicinal products (acetylsalicylic acid, dipyridamole, sulfinpyrazone, ticlopidine or clopidogrel), and NSAIDs should be used with caution.
Danish: Anden trombocythæmmende medicin (acetylsalicylsyre, dipyramidol, sulfinpyrazon, ticlopidin eller clopidogrel) samt NSAIDs bør anvendes med forsigtighed.
English: Picture B2
Danish: Figur B2
English: The diagnosis was confirmed by objective testing (lung scan, pulmonary angiography or spiral CT scan).
Danish: Diagnosen blev bekræftet ved objektive undersøgelser (lungescanning, lungeangiografi eller spiral CT scanning).
English: The primary adjudicated endpoint was a composite of death, myocardial infarction (MI) and refractory ischaemia (RI) within 9 days of randomisation.
Danish: Det primære sammensatte endepunkt var død, myokardieinfarkt (MI) og refraktær iskæmi (RI) senest 9 dage efter randomisering.
English: A pilot dose-finding and pharmacokinetic study of fondaparinux in children with deep vein thrombosis
Danish: Et pilotstudie til kortlæggelse af dosis og farmakokinetik for fondaparinux hos børn med dyb venetrombose
English: The study population was 64% female, with a median age of 58 years, 4.4% had a creatinine clearance <50ml/min.
Danish: Forsøgspopulationen bestod af 64 % kvinder, havde en medianalder på 58 år, og 4,4 % havde kreatininclearance <50 ml/min.
English: 10 mg once a day.
Danish: 10 mg en gang daglig.
English: Aspen Notre Dame de Bondeville, 1 rue de l'Abbaye, F-76960 Notre Dame de Bondeville, France.
Danish: Aspen Notre Dame de Bondeville, 1, rue de l'Abbaye, F-76960 Notre Dame de Bondeville, Frankrig
English: Contact your doctor or pharmacist for advice as soon as possible, because of the increased risk of bleeding.
Danish: Kontakt hurtigst muligt din læge eller apoteket, da der er øget risiko for blødninger.
English: However, rare spontaneous reports of HIT in patients treated with fondaparinux have been received.
Danish: Der er dog set sjældne spontane tilfælde af HIT hos patienter i behandling med fondaparinux.
English: This dose may be reduced to 7.5 mg once a day if you have moderate kidney disease.
Danish: Denne dosis kan blive nedsat til 7,5 mg en gang daglig, hvis du lider af en nyresygdom.
English: Randomised patients received either “low dose” UFH regimen (50 U/kg irrespective of planned GPIIb/IIIa use; non ACT guided) or “standard dose” UFH regimen (no GPIIb/IIIa use: 85 U/kg, ACT guided; planned GPIIb/IIIa use: 60 U/kg, ACT guided) immediately prior to the start of the PCI.
Danish: Randomiserede patienter fik enten "lavdosis"UFH-regimet (50 E/kg uanset brug af planlagt GPIIb/IIIa; ikke ACT-vejledt) eller "standarddosis"UFH-regimet (ingen brug af GPIIb/IIIa: 85 E/kg, ACT-vejledt; planlagt brug af GPIIb/IIIa: 60 E/kg, ACT-vejledt) umiddelbart inden påbegyndelse af PCI.
English: Paediatric patients - Limited data are available in paediatric patients (see section 5.1).
Danish: Pædiatriske patienter - Begrænsede data er tilgængelige hos pædiatriske patienter (se pkt.
English: The risk of bleeding increases with increasing renal impairment.
Danish: Blødningsrisikoen øges med øget nedsættelse af nyrefunktionen.
English: The majority (70/80) of the recorded VTE events were venographically detected non-symptomatic cases of DVT.
Danish: Størstedelen (70/80) af de rapporterede venøse tromboemboliske komplikationer var ikke-symptomatiske tilfælde af DVT, der blev påvist ved flebografi.
English: Consequently, unbound concentrations of fondaparinux are expected to be unchanged in patients with mild to moderate hepatic impairment, and therefore, no dose adjustment is necessary based on pharmacokinetics.
Danish: Som følge heraf, forventes koncentrationen af ubundet fondaparinux at forblive uændret hos patienter med let til moderat nedsat leverfunktion og dosisjustering er derfor ikke nødvendig (baseret på farmakokinetikken).
English: In the large subgroup of patients undergoing cancer surgery (69% of the patient population), the VTE rate was 4.7% in the fondaparinux group, versus 7.7% in the dalteparin group.
Danish: I den store subgruppe af patienter, som gennemgik cancerkirurgi (69 % af patienterne), var forekomsten af VTE 4,7 % i fondaparinuxgruppen versus 7,7 % i dalteparingruppen.
English: The primary efficacy endpoint was the composite of confirmed symptomatic recurrent non-fatal VTE and fatal VTE reported up to Day 97.
Danish: Det primære endepunkt for effekt omfattede bekræftet symptomatisk tilbagevendende ikke-letal VTE og letal VTE indberettet frem til dag 97.
English: There are limited clinical data available from patients with creatinine clearance less than 30 ml/min.
Danish: Der er kun begrænsede kliniske data for patienter med kreatininclearance mindre end 30 ml/min.
English: Sites of administration should alternate between the left and the right anterolateral and left and right posterolateral abdominal wall.
Danish: Injektionsstedet bør alternere mellem højre og venstre anterolaterale samt posterolaterale abdominalvæg.
English: • if you notice that the syringe is damaged
Danish: • hvis du bemærker, at injektionssprøjten er beskadiget.
English: • if you have opened a syringe and you do not use it straightaway.
Danish: • hvis du har lukket op for en sprøjte, som du ikke anvender med det samme.
English: Associated terminal half-life values were 29 h in moderate and 72 h in patients with severe renal impairment.
Danish: Værdierne for terminal halveringstid var 29 timer hos patienter med moderat nedsat nyrefunktion, og 72 timer hos patienter med svært nedsat nyrefunktion.
English: For patients with body weight < 50 kg, the recommended dose is 5 mg. For patients with body weight > 100 kg, the recommended dose is 10 mg.
Danish: Til patienter, der vejer <50 kg, er den anbefalede dosis 5 mg. Til patienter, der vejer >100 kg, er den anbefalede dosis 10 mg.
English: PCI and risk of guiding catheter thrombus
Danish: PCI og risiko for kateterrelateret trombose
English: Fondaparinux must not be administered intramuscularly.
Danish: Fondaparinux må ikke administreres intramuskulært.
English: Aspen Notre Dame de Bondeville 1, rue de l'Abbaye F-76960 Notre Dame de Bondeville France
Danish: Aspen Notre Dame de Bondeville 1, rue de l'Abbaye 76960 Notre Dame de Bondeville Frankrig
English: Remove the needle shield, by first twisting it (picture B1), and then pulling it in a straight line away from the body of the syringe (picture B2).
Danish: Fjern kanylehylsteret ved først at dreje det (fig. B1) og dernæst trække det i lige linje væk fra sprøjtens cylinder (fig. B2).
English: Paediatric population - Fondaparinux is not recommended for use in children below 17 years of age due to a lack of data on safety and efficacy.
Danish: Pædiatrisk population - Fondaparinux bør ikke anvendes til børn under 17 år pga. manglende dokumentation for sikkerhed og virkning.
English: Low body weight
Danish: Lav legemsvægt
English: How long should Arixtra be taken for
Danish: Hvor længe skal du tage Arixtra
English: Fondaparinux is intended for subcutaneous use only.
Danish: Fondaparinux er udelukkende beregnet til subkutan indgift.
English: There is limited experience from treatment with fondaparinux in haemodynamically unstable patients and no experience in patients requiring thrombolysis, embolectomy or insertion of a vena cava filter.
Danish: Der er begrænsede erfaringer med behandling af hæmodynamisk ustabile patienter med fondaparinux, og ingen erfaringer med patienter, der kræver trombolyse, embolektomi eller indlæggelse af vena cava-filter.
English: Arixtra contains sodium
Danish: Arixtra indeholder natrium