FrancophonIA/ELRC3.0 huggingface dataset:
English: In the event of polycythaemia, Aranesp should be temporarily withheld (see section 4.2).
Danish: I tilfælde af polycytæmi bør Aranesp midlertidigt seponeres (se pkt.
English: Push down
Danish: Tryk ned
English: A paradoxical decrease in haemoglobin and development of severe anaemia associated with low reticulocyte counts should prompt to discontinue treatment with epoetin and perform anti-erythropoietin antibody testing.
Danish: Et paradoks fald i hæmoglobin og udvikling af svær anæmi i forbindelse med lave retikulocyttal bør medføre seponering af epoetin og udførelse af test for anti-erytropoietin-antistoffer.
English: If your doctor has decided to change your treatment from r-HuEPO (erythropoietin produced by gene-technology) to Aranesp, they will choose whether you should receive your Aranesp injection once weekly or once every two weeks.
Danish: Hvis Deres læge beslutter at skifte Deres behandling fra r-HuEPO (genfremstillet erythropoietin) til Aranesp, vælger lægen også, om De skal have en Aranesp-injektion én gang om ugen eller én gang hver anden uge.
English: In patients with chronic renal failure, maintenance haemoglobin concentration should not exceed the upper limit of the target haemoglobin concentration recommended in section 4.2.
Danish: Hos patienter med kronisk nyresvigt må vedligeholdelseskoncentrationen af hæmoglobin ikke overstige den øvre grænse for den målkoncentration af hæmoglobin, der er anbefalet under pkt.
English: Patients starting dialysis during treatment with Aranesp should be closely monitored for adequate control of their haemoglobin.
Danish: Patienter, der starter i dialyse under behandling med Aranesp, skal monotoreres omhyggeligt med henblik på passende kontrol af deres hæmoglobinkoncentration.
English: Treatment of paediatric patients younger than 1 year of age has not been studied in randomised clinical trials (see section 5.1).
Danish: Behandling af børn under 1 år er ikke undersøgt i randomiserede kliniske forsøg (se pkt.
English: Talk to your doctor, pharmacist or nurse before using Aranesp.
Danish: Kontakt lægen, apotekspersonalet eller sygeplejersken, før De bruger Aranesp.
English: Two of the studies recruited patients who were being treated with chemotherapy.
Danish: To af studierne omhandlede patienter, som modtog kemoterapi.
English: • Check that it is the correct dose that your healthcare provider has prescribed.
Danish: • Kontrollér, at dosen er korrekt som ordineret af sundhedspersonalet.
English: When changing the route of administration the same dose must be used and the haemoglobin monitored every one or two weeks so that the appropriate dose adjustments can be made to keep the haemoglobin at the desired level.
Danish: Hvis administrationsvejen ændres, skal samme dosis benyttes og hæmoglobinkoncentrationen skal monitoreres hver eller hveranden uge, så passende dosisjustering kan foretages for at holde hæmoglobinkoncentrationen på det ønskede niveau.
English: Source: Includes 5 randomised, double-blind, active-controlled studies (970200, 970235, 980117, 980202, and
Danish: Kilde: Omfatter 5 randomiserede, dobbeltblindede, aktivt kontrollerede studier (970200, 970235, 980117,
English: Serum potassium levels should be monitored regularly during Aranesp therapy.
Danish: Niveauet af serumkalium bør kontrolleres regelmæssigt under behandlingen med Aranesp.
English: Window Medicine Make sure the medicine in the window is a clear and colourless liquid.
Danish: Sørg for, at lægemidlet i vinduet er en klar og farveløs væske.
English: • Avoid injecting into areas with scars or stretch marks.
Danish: • Undgå at injicere i områder, hvor der er ar og strækmærker.
English: Pooled post-hoc analyses of clinical studies of ESAs have been performed in chronic renal failure patients (on dialysis, not on dialysis, in diabetic and non-diabetic patients).
Danish: Der er blevet gennemført samlede post-hoc-analyser af kliniske studier med ESA'er hos patienter med kronisk nyresvigt (patienter i dialyse, ikke i dialyse, med og uden diabetes).
English: In studies performed in rats and rabbits no clinically relevant evidence of harmful effects with respect to pregnancy, embryonal/ foetal development, parturition or postnatal development was observed.
Danish: I studier udført på rotter og kaniner blev der ikke observeret nogen kliniske relevante beviser for skadelig effekt hverken hvad angår graviditet, fosterudvikling, fødsel eller postnatal udvikling.
English: Due to its increased carbohydrate content darbepoetin alfa has a longer terminal half-life than r-HuEPO and consequently a greater in vivo activity.
Danish: På grund af dets øgede kulhydratindhold har darbepoetin alfa en længere terminal halveringstid end r-HuEPO og som konsekvens heraf en større in vivo-aktivitet.
English: There is therefore consistent evidence to suggest that there may be significant harm to patients with cancer who are treated with recombinant human erythropoietin.
Danish: Der er dermed konsekvente tegn på, at stoffet kan være til væsentlig skade for patienter med cancer, som modtager behandling med rekombineret humant erytropoietin.
English: The terminal half-life of darbepoetin alfa is 21 hours (SD 7.5) when administered intravenously.
Danish: Darbepoetin alfas terminale halveringstid er 21 timer (SD 7,5) ved intravenøs administration.
English: Erythropoietin is produced in your kidneys and encourages your bone marrow to produce more red blood cells.
Danish: Erythropoietin produceres i nyrerne og stimulerer Deres knoglemarv til at producere flere røde blodlegemer.
English: One of the main side effects of chemotherapy is that it stops the bone marrow producing enough blood cells.
Danish: En af hovedbivirkningerne ved kemoterapi er, at den forhindrer knoglemarven i at producere tilstrækkeligt mange røde blodlegemer.
English: INSERT the needle into skin.
Danish: STIK kanylen ind i huden.
English: Step 1: Prepare A Remove the pre-filled syringe tray from the package and gather the supplies needed for your injection: alcohol wipes, a cotton ball or gauze pad, a plaster and a sharps disposal container (not included).
Danish: Trin 1: Forbered A Tag bakken med den fyldte injektionssprøjte ud af pakningen og saml de ting sammen, der skal bruges til injektionen: afspritningsservietter, vat eller gazekompresser, plaster og en kanylebøtte (følger ikke med).
English: Release button
Danish: Slip knappen
English: With the grey cap off, place the pre-filled pen on your skin at 90 degrees.
Danish: Tag den grå hætte af og placer den fyldte pen på huden i en vinkel af 90 grader.
English: Aranesp contains sodium
Danish: Aranesp indeholder natrium
English: This was a non inferiority study designed to rule out a 15% risk increase in tumour progression or death of epoetin alfa plus standard of care (SOC) as compared with SOC alone.
Danish: Det var et noninferioritetsstudie, som var designet til at udelukke en 15 % stigning i risikoen for tumorprogression eller død ved behandling med epoetin alfa plus standardbehandling sammenlignet med standardbehandling alene.
English: In these studies, no meaningful differences were identified between the safety profile for paediatric patients and that previously reported for adult patients (see section 4.8).
Danish: Der blev i disse studier ikke observeret en betydningsfuld forskel mellem sikkerhedsprofilen for pædiatriske patienter og den tidligere rapporterede sikkerhedsprofil for voksne patienter (se pkt.
English: In these patients, erythropoietin deficiency and a reduced response of erythroid progenitor cells to endogenous erythropoietin both contribute significantly towards their anaemia.
Danish: For disse patienter bidrager både erytropoietinmanglen og det nedsatte respons på erythroide stamceller af endogent erytropoietin, betydeligt til deres anæmi.
English: Production of endogenous erythropoietin is impaired in patients with chronic renal failure and the primary cause of their anaemia is due to erythropoietin deficiency.
Danish: Produktionen af endogent erytropoietin er nedsat hos patienter med kronisk nyresvigt og den primære årsag til deres anæmi er erytropoietinmangel.
English: If the haemoglobin continues to increase, the dose should be reduced by approximately 25%.
Danish: Hvis hæmoglobinkoncentrationen fortsat stiger, bør dosis reduceres med ca. 25 %.
English: Do not inject into areas where the skin is tender, bruised, red, or hard.
Danish: Injicer ikke i områder, hvor huden er øm, har blå mærker, er rød eller hård.
English: • 500 micrograms once every three weeks (6.75 micrograms of Aranesp per kilogram of your body weight), or
Danish: • 500 mikrogram én gang hver tredje uge (6,75 mikrogram Aranesp pr. kilo kropsvægt) eller
English: This study supports 500 mcg once every three weeks being comparable to once weekly administration with respect to the incidence of subjects receiving at least one red blood cell transfusion from week 5 to the end of treatment phase.
Danish: Studien understøtter antagelsen om, at 500 mikrog én gang hver tredje uge er sammenlignelig med en ugentlig dosis, når det gælder hyppigheden af forsøgspersonernes modtagelse af mindst én transfusion med røde blodlegemer i perioden fra uge 5 til slutningen af behandlingsforløbet.
English: The extent to which these outcomes might apply to the administration of recombinant human erythropoietin to patients with cancer, treated with chemotherapy to achieve haemoglobin concentrations less than 13 g/dL, is unclear because few patients with these characteristics were included in the data reviewed.
Danish: Det er uklart, i hvor høj grad disse resultater berører indgivelsen af rekombineret humant erytropoietin til patienter med cancer, som modtager kemoterapi med det formål at opnå en hæmoglobinkoncentration på under 13 g/dl, fordi de medtagne data kun indeholder få patienter med disse karakteristika.
English: In case PRCA is diagnosed, therapy with Aranesp must be discontinued and patients should not be switched to another recombinant erythropoietic protein (see section 4.4).
Danish: Hvis PRCA diagnosticeres, skal Aranesp seponeres, og patienten må ikke skifte til et andet rekombinant erytropoietisk protein (se pkt.
English: Injection site pain was reported as attributable to treatment in studies where Aranesp was administered via subcutaneous injection.
Danish: Der er indberettet smerter på injektionsstedet, som tilskrives behandlingen, i studier, hvor Aranesp blev indgivet som subkutan injektion.
English: Your doctor has given you Aranesp (an anti-anaemic) to treat your anaemia.
Danish: Deres læge har ordineret Aranesp (et lægemiddel mod blodmangel) til Dem for at behandle Deres blodmangel.
English: The haemoglobin should be measured every one or two weeks until it is stable.
Danish: Hæmoglobinkoncentrationen skal måles en gang om ugen eller en gang hver anden uge, indtil det er stabilt.
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Aranesp therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Danish: Det skal besluttes, om amning eller behandling med Aranesp skal ophøre, idet der tages højde for fordelen ved amning for barnet i forhold til de terapeutiske fordele for moderen.
English: These can appear as reddish target-like macules or circular patches often with central blisters on the trunk, skin peeling, ulcers of mouth, throat, nose, genitals and eyes and can be preceded by fever and flu-like symptoms.
Danish: Dette kan vise sig på kroppen som rødlige pletter, der ligner skydeskiver, eller runde pletter, ofte med blærer i midten, hudafskalning, sår i mund, hals og næse, på kønsorganerne og i øjnene og kan komme efter feber og influenzalignende symptomer.
English: Do not touch the needle or push the plunger.
Danish: Rør ikke ved kanylen og skub ikke til stemplet.
English: Following monthly administration of darbepoetin alfa, at subcutaneous doses ranging from 0.6 to 2.1 mcg/kg, the terminal half-life was 73 hours (SD 24).
Danish: Efter månedlig administration af darbepoetin alfa ved subkutane doser fra 0,6 til 2,1 mikrog/kg var den terminale halveringstid 73 timer (SD 24).
English: Potassium elevation has been reported in a few patients receiving Aranesp, though causality has not been established.
Danish: Kaliumforhøjelse er blevet rapporteret hos nogle få patienter i behandling med Aranesp, selvom årsagssammenhæng ikke er blevet påvist.
English: Step 3: Inject G Hold the stretch or pinch.
Danish: Trin 3: Injicer G Hold huden udstrakt eller knebet sammen.
English: • Additional risk minimisation measures for Aranesp solution for injection in pre-filled pen
Danish: • Yderligere risikominimeringsforanstaltninger for Aranesp injektionsvæske, opløsning i fyldt pen
English: Epoetins are growth factors that primarily stimulate red blood cell production.
Danish: Epoetiner er vækstfaktorer, der hovedsageligt stimulerer dannelsen af røde blodlegemer.
English: Aranesp should be used with caution in patients with epilepsy.
Danish: Aranesp bør bruges med forsigtighed hos patienter med epilepsi.
English: Clearance of darbepoetin alfa is 1.9 mL/hr/kg (SD 0.56) and the volume of distribution (Vss) is approximately equal to plasma volume (50 mL/kg).
Danish: Clearance for darbepoetin alfa er 1,9 ml/t/kg (SD 0,56) og fordelingsvolumen (Vss) er omtrent lig plasmavolumen (50 ml/kg).
English: Data from 809 patients receiving Aranesp in European clinical studies were analysed to assess the dose required to maintain haemoglobin; no difference was observed between the average weekly dose administered via the intravenous or subcutaneous routes of injection.
Danish: Resultater opnået ved indgift af Aranesp til 809 patienter i kliniske studier i Europa blev analyseret med henblik på at kunne fastsætte den dosis, som er påkrævet for at fastholde hæmoglobin; der blev ikke observeret nogen forskel på den gennemsnitlige ugentlige dose uanset om injektionen skete intravenøst eller subkutant.
English: If you are receiving chemotherapy
Danish: Hvis De er i kemoterapi
English: For all adults and paediatric patients ≥ 11 years of age not on dialysis, Aranesp could also be given as an injection once monthly.
Danish: For alle voksne og pædiatriske patienter ≥ 11 år, som ikke er i dialyse, kan Aranesp også gives som en injektion én gang om måneden.
English: The pharmacokinetics of darbepoetin alfa has been studied clinically in chronic renal failure patients following intravenous and subcutaneous administration.
Danish: Darbepoetin alfas farmakokinetik er blevet klinisk undersøgt hos patienter med kronisk nyresvigt efter intravenøs og subkutan administration.
English: These studies have shown a consistent unexplained statistically significant excess mortality in patients who have anaemia associated with various common cancers who received recombinant human erythropoietin compared to controls.
Danish: Disse studier har påvist en konsekvent, men uforklarlig statistik signifikant overdødelighed hos patienter med anæmi, der er forbundet med forskellige almindelige former for cancer, og som modtog behandling med rekombineret humant erytropoietin sammenlignet med kontroller.
English: Also, ulcers of mouth, throat, nose, genitals and eyes (red and swollen eyes) can occur.
Danish: Desuden kan der opstå sår i mund, hals og næse, på kønsorganerne og i øjnene (røde og hævede øjne).
English: Do not use the pre-filled pen if any part appears cracked or broken.
Danish: Brug ikke den fyldte pen, hvis en enkelt del ser revnet eller ødelagt ud.
English: Prepare and clean your injection site.
Danish: Forbered og rengør injektionsstedet.
English: Put the used pre-filled pen in the sharps disposal container immediately after use.
Danish: Læg den brugte fyldte pen i en beholder til bortskaffelse af skarpe genstande umiddelbart efter brug.
English: • 2.25 micrograms (once weekly) of Aranesp per kilogram of your body weight.
Danish: • 2,25 mikrogram Aranesp (én gang ugentligt) pr. kilogram kropsvægt.
English: Meta-analyses also indicate consistently a significantly increased relative risk of thromboembolic events in cancer patients receiving recombinant human erythropoietin (see section 4.4).
Danish: Desuden indikerer meta-analyser konsekvent en signifikant forhøjet relativ risiko for tromboemboliske hændelser hos cancerpatienter, der får rekombinant human erytropoietin (se pkt.
English: The best places to inject yourself are the top of your thighs and the abdomen.
Danish: De bedste steder at give indsprøjtningen er højt oppe på låret og i maveregionen.
English: Aranesp has no or negligible influence on the ability to drive and use machines.
Danish: Aranesp påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: If Aranesp is given concomitantly with any of these treatments, blood levels of these substances should be monitored and the dosage adjusted as the haemoglobin rises.
Danish: Hvis Aranesp gives samtidig med nogle af disse behandlinger, skal koncentrationen af disse stoffer i blodet monitoreres og dosis justeres, når hæmoglobinkoncentrationen stiger.
English: - If you have symptoms which include severe headache, drowsiness, confusion, problems with your eyesight, nausea, vomiting or fits (seizures), it could mean that you have very high blood pressure.
Danish: - Hvis De har symptomer, der blandt andet kan være kraftig hovedpine, døsighed, forvirring, synsforstyrrelser, kvalme, opkastning eller kramper (krampeanfald), kan det betyde, at De har et meget højt blodtryk.
English: In the once weekly group, 75% of patients required dose reductions.
Danish: I gruppen, som modtog dosis én gang om ugen, krævede 75 % af patienterne dosisreduktioner.
English: It must be a clear and colourless liquid.
Danish: Den skal være en klar og farveløs væske.
English: Hypersensitivity reactions have been observed in cancer patients in post-marketing experience.
Danish: Der er observeret overfølsomhedsreaktioner hos cancerpatienter efter markedsføring.
English: • Rash and/or redness of the skin
Danish: • Udslæt og/eller hudrødmen
English: • New pre-filled pen
Danish: • Ny fyldt pen
English: If the bone marrow is consistent with PRCA, testing for anti-erythropoietin antibodies should be performed.
Danish: Hvis knoglemarven er i overensstemmelse med PRCA, bør en anti-erytropoietin-antistoftest udføres.
English: Effect on tumour growth
Danish: Virkning på tumorprogression
English: In a phase 1 pharmacokinetic study, following intravenous administration, an approximate 25% difference between paediatric and adult patients in the area under the curve from time 0 to infinity (AUC[0-∞]) was observed; however, this difference was less than the 2-fold range in AUC(0-∞) observed for the paediatric patients.
Danish: I et farmakokinetisk fase 1-studie blev der efter intravenøs administration observeret en forskel på ca. 25 % mellem børn og voksne i området under kurven fra en tidsfaktor 0 til ubestemt tid (AUC[0-∞]).
English: There are additional educational materials available to train you on how to self administer Aranesp pre-filled pen, a dummy demonstration device and a poster-size instructions for use for patients/caregivers with diminished eyesight.
Danish: Der findes andet undervisningsmateriale til undervisning i, hvordan De selv bruger Aranesp fyldt pen, en attrap-pen til demonstrationsbrug samt en brugsanvisning i plakatstørrelse til patienter/omsorgspersoner med nedsat syn.
English: These parameters were consistent with dose linear pharmacokinetics over a wide dose range (0.5 to 8 mcg/kg weekly and 3 to 9 mcg/kg every two weeks).
Danish: Disse parametre stemte overens med den lineære dosis farmakokinetik over et bredt dosisinterval (0,5 til 8 mikrog/kg ugentlig og 3 til 9 mikrog/kg hver anden uge).
English: It is normal to see a drop of liquid at the end of the needle or yellow safety guard.
Danish: De vil muligvis kunne se en dråbe væske i spidsen af nålen eller den gule sikkerhedsanordning.
English: Caution should be exercised with escalation of Aranesp doses in patients with chronic renal failure, since high cumulative epoetin doses may be associated with an increased risk of mortality, serious cardiovascular and cerebrovascular events.
Danish: Der skal udvises forsigtighed ved optitrering af Aranesp-dosis hos patienter med kronisk nyresvigt, da høje, kumulative epoetindoser kan være forbundet med en øget risiko for mortalitet og alvorlige kardiovaskulære og cerebrovaskulære hændelser.
English: Your doctor will take regular blood samples to measure how your anaemia is responding and may adjust your dose once every four weeks as necessary in order to maintain long term control of your anaemia.
Danish: Deres læge vil regelmæssigt tage blodprøver for at måle, hvordan Deres anæmi reagerer på behandlingen og justere Deres dosis hver fjerde uge, hvis det er nødvendigt for at sikre langvarig kontrol af anæmien.
English: Subcutaneous use is preferable in patients who are not receiving haemodialysis to avoid the puncture of peripheral veins.
Danish: Subkutan indgivelse foretrækkes hos patienter, der ikke er i hæmodialyse, for at undgå perifer venepunktur.
English: Aranesp is administered either subcutaneously or intravenously as described in the posology.
Danish: Aranesp indgives enten subkutant eller intravenøst som beskrevet under dosering.
English: Convulsions were common in the placebo groups.
Danish: Krampeanfald var almindelig i placebogrupperne.
English: Do not warm Aranesp in any other way (for example, do not warm it in a microwave or in hot water).
Danish: Aranesp må ikke opvarmes på nogen anden måde (fx i mikrobølgeovn eller varmt vand).
English: Do not twist or bend the grey cap.
Danish: Vrid eller bøj ikke den grå hætte.
English: • A poster-size instructions for use (for patients/caregivers with diminished eyesight) - includes the instructions for use located in the package leaflet in a way that patients/caregivers with diminished eyesight are informed on how to handle the pen and administer Aranesp appropriately.
Danish: • En brugsanvisning i plakatstørrelse (til patienter/omsorgspersoner med nedsat syn) - indeholder den brugsanvisning, der findes i indlægssedlen, på en måde så patienter/omsorgspersoner med nedsat syn informeres om, hvordan de skal håndtere pennen og administrere Aranesp korrekt.
English: D Prepare and clean your injection site.
Danish: D Forbered og rengør injektionsstedet.
English: Convulsions have been reported in patients receiving Aranesp.
Danish: Krampeanfald er blevet rapporteret hos patienter, der får Aranesp.
English: Your doctor may decide that it is best for you or a carer to inject Aranesp.
Danish: Deres læge kan beslutte, at det er bedst for Dem, hvis De selv eller en sygeplejerske injicerer Aranesp.
English: • increased risk of death when administered to target a haemoglobin of 12 g/dL (7.5 mmol/L) in patients with active malignant disease receiving neither chemotherapy nor radiation therapy.
Danish: • øget risiko for dødsfald, når det indgives for at behandle en hæmoglobinkoncentration på 12 g/dl (7,5 mmol/l) hos patienter med aktiv malign sygdom, som hverken modtager kemoterapi eller strålebehandling.
English: The frequency is estimated from clinical trial data as common in cancer patients and was also common in the placebo groups.
Danish: Hyppigheden er på baggrund af kliniske forsøgsdata estimeret som almindelig hos cancerpatienter og var også almindelig i placebogrupperne.
English: Do not use the pre-filled pen if the medicine is cloudy or discoloured or contains flakes or particles.
Danish: Brug ikke den fyldte pen, hvis lægemidlet er uklart eller misfarvet eller indeholder flager eller partikler.
English: Haemoglobin concentrations were corrected to ≥ 10 g/dL in > 98% (p < 0.001) of paediatric patients administered darbepoetin alfa once weekly and 84% (p = 0.293) once every two weeks.
Danish: Hæmoglobinkoncentrationerne blev korrigeret til ≥ 10 g/dl hos > 98 % (p < 0,001) af de patienter, som fik administreret darbepoetin alfa én gang ugentligt og 84 % (p = 0,293) én gang hver 14. dag.